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Name (Synonyms) | Correlation | |
---|---|---|
drug678 | CVnCoV Vaccine Wiki | 0.38 |
drug2490 | Placebo Wiki | 0.35 |
drug157 | Ad26.COV2.S Wiki | 0.31 |
Name (Synonyms) | Correlation | |
---|---|---|
drug384 | BNT162b1 Wiki | 0.31 |
drug3578 | Vaccinated with polio vaccine (IPV) Wiki | 0.27 |
drug674 | CVnCoV Wiki | 0.27 |
drug840 | Comparable Placebo of drug Wiki | 0.27 |
drug1437 | Heparin Wiki | 0.27 |
drug385 | BNT162b2 Wiki | 0.27 |
drug454 | Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo group Wiki | 0.27 |
drug103 | ARCT-021 single dose priming Wiki | 0.27 |
drug677 | CVnCoV 6 μg Wiki | 0.27 |
drug739 | ChAdOx1 nCoV-19 single dose + paracetamol Wiki | 0.27 |
drug1359 | GM-CSF Wiki | 0.27 |
drug2108 | NA-831 Wiki | 0.27 |
drug2504 | Placebo (two doses), priming Wiki | 0.27 |
drug2002 | MenACWY single dose + paracetamol Wiki | 0.27 |
drug386 | BNT162b3 Wiki | 0.27 |
drug676 | CVnCoV 12μg Wiki | 0.27 |
drug2593 | Pneumococcal vaccine Wiki | 0.27 |
drug740 | ChAdOx1 nCoV-19 two dose + paracetamol Wiki | 0.27 |
drug1443 | Hepatitis A vaccine Wiki | 0.27 |
drug2312 | One COVID-19 vaccine candidate (TMV-083) administration - High dose Wiki | 0.27 |
drug452 | Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group Wiki | 0.27 |
drug453 | Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group Wiki | 0.27 |
drug2503 | Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%) Wiki | 0.27 |
drug3494 | Two COVID-19 vaccine candidate (TMV-083) administrations - High dose Wiki | 0.27 |
drug829 | Combination of oral polio vaccine and NA-831 Wiki | 0.27 |
drug1583 | IIBR-100, low dose (prime) Wiki | 0.27 |
drug458 | Biological: oral polio vaccine Wiki | 0.27 |
drug3495 | Two COVID-19 vaccine candidate (TMV-083) administrations - Low dose Wiki | 0.27 |
drug1582 | IIBR-100 medium dose (prime) Wiki | 0.27 |
drug1581 | IIBR-100 low-dose (prime-boost) Wiki | 0.27 |
drug1869 | Low Dose of KBP-COVID-19 Wiki | 0.27 |
drug2787 | Randomized booster Wiki | 0.27 |
drug2001 | MenACWY prime & saline placebo boost + paracetamol Wiki | 0.27 |
drug2806 | Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo Wiki | 0.27 |
drug105 | ARCT-021 two lower dose priming Wiki | 0.27 |
drug104 | ARCT-021 two higher dose priming Wiki | 0.27 |
drug839 | Comparable Placebo of Oral Polio Vaccine and Placebo of drug Wiki | 0.27 |
drug838 | Comparable Placebo Wiki | 0.27 |
drug1447 | High Dose of KBP-COVID-19 Wiki | 0.27 |
drug675 | CVnCoV 12 μg Wiki | 0.27 |
drug623 | COVID-19 convalescent plasma Wiki | 0.27 |
drug1580 | IIBR-100 high-dose (prime) Wiki | 0.27 |
drug928 | Covax-19™ Wiki | 0.27 |
drug1210 | EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) Wiki | 0.27 |
drug2530 | Placebo booster Wiki | 0.27 |
drug2988 | Saline Placebo Wiki | 0.19 |
drug370 | BCG-Denmark Wiki | 0.15 |
drug119 | AV-COVID-19 Wiki | 0.15 |
drug366 | BCG Vaccine Wiki | 0.13 |
drug2805 | Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki | 0.12 |
drug2985 | Saline Wiki | 0.12 |
Navigate: Correlations HPO
There are 14 clinical trials
This study is a randomized, double-blind, placebo -controlled IIb clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people 6 years old and above and .
Description: Occurrence of adverse reactions post vaccination
Measure: Safety indexes of adverse reactions Time: within 14 days post each vaccinationDescription: Evaluate the Geometric mean titer (GMT) of IgG antibody
Measure: Immunogencity indexes of GMT Time: Day 28 post the second vaccinationDescription: Evaluate the Geometric mean titer (GMT) of neutralizing antibody
Measure: Immunogencity indexes of neutralizing antibody Time: Day 28 post the second vaccinationDescription: Occurrence of adverse reactions post-vaccination
Measure: Safety indexes of adverse events Time: Day 0-7,0-14,0-28 post each vaccinationDescription: Occurrence of abnormal changes of Hematological examination indexes(only fit for MID and sentinel group)
Measure: Safety indexes of Hematological examination measures(Hemoglobin, WBC) Time: pre-vaccination, day 4 post each vaccinationDescription: Occurrence of abnormal changes of lBlood routine indexes (only fit for MID and sentinel group)
Measure: Safety indexes of Blood routine measures(ALT, AST) Time: pre-vaccination, day 4 post each vaccinationDescription: Occurrence of serious adverse events post-vaccination
Measure: Safety indexes of SAE Time: Within 6 months post the second vaccinationDescription: Evaluate the Geometric mean titer of IgG antibody
Measure: Immunogencity indexes of GMT Time: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccinationDescription: Evaluate the Geometric mean titer (GMT) of neutralizing antibody
Measure: Immunogencity indexes of neutralizing antibody Time: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccinationDescription: Number of cell-mediated immune response against SARS-CoV-2(IL-2)
Measure: Immunogencity indexes of cellular immune Time: Day 28 post the first vaccination, pre and day 28 post the second vaccinationThis study aims to: - Demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any severity in SARS-CoV-2 naïve participants. - Demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episode of virologically-confirmed moderate to severe cases of COVID-19 in SARS-CoV-2 naïve participants.
Description: Seroconversion is defined as detectable SARS-CoV-2 N protein antibodies in the serum of asymptomatic seronegative participants who tested seronegative on Day 1 and on Day 43.
Measure: Number of participants with seroconversion to the nucleocapsid (N) protein of SARS-CoV-2 ≥ 15 days after the second study vaccination Time: Days 1, 43, 211 and 393Description: S protein will be measured by enzyme-linked immunosorbent assay (ELISA).
Measure: Number of participants with serum antibodies to SARS-CoV-2 spike (S) protein Time: Days 1, 29, 43, 57, 120, 211 and 393Description: S protein will be measured by enzyme-linked immunosorbent assay (ELISA). Seroconversion is defined as detectable SARS-CoV-2 S protein antibodies in the serum of participants who tested seronegative on Day 1.
Measure: Number of participants who experience seroconversion to SARS-CoV-2 spike (S) protein Time: Days 1, 29, 43, 57, 120, 211 and 393Description: Serum vital neutralizing antibodies to SARS-CoV-2 virus will be measured by a viral neutralizing antibody assay.
Measure: Number of participants with serum vital neutralizing antibodies to SARS-CoV-2 virus Time: Days 1, 29, 43, 57, 120, 211 and 393Description: Seroconversion to SARS-CoV-2 virus will be measured by a viral neutralizing antibody assay. Seroconversion is defined as detectable SARS-CoV-2 viral neutralizing antibodies in the serum of participants who tested seronegative on Day 1.
Measure: Number of participants who experience seroconversion to SARS-CoV-2 virus Time: Days 1, 29, 43, 57, 120, 211 and 393This is a randomized, placebo-controlled, two center, Phase I trial in healthy adult volunteer participants consisting of two phases, an unblinded dose escalation and a double blind treatment phase to investigate the safety, tolerability and immunogenicity of a novel measles-vector based vaccine candidate against SARS-CoV-2 infection (TMV-083).
Description: Rate of solicited Adverse Event up to 14 days after each injection. Rate of unsolicited AE up to 28 days after the last injection. Rate of serious adverse events (SAEs), serious adverse reactions (SARs), suspected unexpected serious adverse reactions (SUSARs) and adverse events of special interest (AESI) all along the study period.
Measure: To assess the safety and tolerability of the COVID-19 vaccine following one or two consecutive intramuscular injections in healthy volunteers Time: Day 390Description: SARS-CoV-2 specific antibodies up to study day 390 as measured by spike protein-specific ELISA
Measure: To assess induction of SARS-CoV-2 spike protein-binding antibodies upon one or two administrations of the COVID-19 vaccine by means of ELISA up to study day 390 Time: Day 390Description: SARS-CoV-2 specific antibodies up to study day 390 for each cohort as measured by serum neutralization assay
Measure: To assess induction of SARS-CoV-2 neutralizing antibodies upon one or two administrations of the COVID-19 vaccine by means of serum neutralization assay up to study day 390 Time: Day 390Description: SARS-CoV-2 spike protein-specific cell-mediated immune response up to study day 390 induced by one or two doses as measured by intracellular staining and flow cytometry
Measure: To assess SARS-CoV-2 spike protein-specific, cell-mediated immune responses up to study day 390, induced by one or two doses of vaccine, by means of intracellular staining and flow cytometry. Time: up to Day 390Description: Occurrence of measles virus shedding as evidenced by a positive RT-PCR for saliva, nasal swab, urine, or blood sample in sentinel groups.
Measure: To assess potential measles virus shedding by means of RT-qPCR of saliva, nasal swab, urine, or blood samples in sentinel groups on day 0 and up to day 42 Time: up to Day 42Description: Measles virus antibody levels as assessed by standard ELISA assays on day 0 and day 28.
Measure: To assess the anti-measles antibody levels at baseline and on day 28 by ELISA Time: up to Day 28Description: SARS-CoV-2 N protein specific antibody up to study day 390 as measured by ELISA to differentiate the response to the COVID-19 vaccine from infection
Measure: To assess the natural exposure of the subjects to SARS-CoV-2 during the duration of the trial by means of N protein-specific ELISA Time: Day 390Description: Occurrence of confirmed COVID-19 (i.e. asymptomatic, paucisymptomatic or symptomatic) cases in the study participant all along the study period
Measure: To assess the occurrence of COVID-19 cases in study participants all along the duration of the study Time: Day 390This trial has two parts. Part A, a dose finding part, with three dose escalation cohorts, one dose de-escalation cohort, three dose refinement cohorts, and up to three optional cohorts in older subjects. Part B, a part with expansion cohorts with dose levels which are selected using data generated in Part A. The vaccine BNT162b3 will be administered using a Prime/Boost (P/B) regimen.
Description: At 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, 162±7 days, and 365±14 days after the boost immunization.
Measure: Functional antibody responses. Time: up to 365 days following dose administrationDescription: At 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, 162±7 days, and 365±14 days after the boost immunization.
Measure: Fold increase in functional antibody titers. Time: up to 365 days following dose administrationDescription: At 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, 162±7 days, and 365±14 days after the boost immunization.
Measure: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline. Time: up to 365 days following dose administrationThis is an First In Human (FIH), observer-blinded, randomized, placebo-controlled, parallel group study to evaluate the safety and immunogenicity of KBP-COVID-19 vaccine in healthy CoV-2seronegative adult subjects in 2 age groups, Part A (18-49 years) and Part B (50-70 years).
Description: Occurrence of Adverse Events
Measure: Solicited Administration site reactions Time: 7 days after vaccinationDescription: Occurrence of Adverse Events
Measure: Solicited systemic events Time: 7 days after vaccinationDescription: Safety Endpoints
Measure: Unsolicited Adverse Events and medically attended adverse events Time: 43 days after vaccinationDescription: Safety Endpoints
Measure: Serious Adverse Events, Medically Attended Adverse Events and New Onset Chronic Diseae Time: 365 days after vaccinationDescription: Immunogenicity
Measure: Vaccine ELISA and neutralizing antibody titers for each treatment group Time: Baseline, Day 8, 15, 22, 29, 43, 90, 181, 273, 365Description: Immunogenicity
Measure: Seroconversion rates Time: Days 8, 15, 22, 29, 43, 90, 181, 273, 365This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. The study will evaluate the safety, tolerability, and immunogenicity of 2 different SARS CoV 2 RNA vaccine candidates against COVID 19 and the efficacy of 1 candidate: - As a 2-dose (separated by 21 days) schedule; - At various different dose levels in Phase 1; - In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]). The candidate selected for evaluation in Phase 2/3 is BNT162b2 (mid-dose). Participants ≥16 years of age who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study.
Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Measure: Percentage of participants in Phase 1 reporting local reactions Time: For 7 days after dose 1 and dose 2Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
Measure: Percentage of participants in Phase 1 reporting systemic events Time: For 7 days after dose 1 and dose 2Description: As elicited by investigational site staff
Measure: Percentage of participants in Phase 1 reporting adverse events Time: From dose 1 through 1 month after the last doseDescription: As elicited by investigational site staff
Measure: Percentage of participants in Phase 1 reporting serious adverse events Time: From dose 1 through 6 months after the last doseDescription: As measured at the central laboratory
Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values Time: 1 day after dose 1Description: As measured at the central laboratory
Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values Time: 7 days after dose 1Description: As measured at the central laboratory
Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values Time: 7 days after dose 2Description: As measured at the central laboratory
Measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments Time: Between baseline and 1 day after dose 1Description: As measured at the central laboratory
Measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments Time: Between baseline and 7 days after dose 1Description: As measured at the central laboratory
Measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments Time: Between before dose 2 and 7 days after dose 2Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions Time: For 7 days after dose 1 and dose 2Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events Time: For 7 days after dose 1 and dose 2Description: As elicited by investigational site staff
Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events Time: From dose 1 through 1 month after the last doseDescription: As elicited by investigational site staff
Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events Time: From dose 1 through 6 months after the last doseDescription: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Measure: In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions Time: For 7 days after dose 1 and dose 2Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
Measure: In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events Time: For 7 days after dose 1 and dose 2Description: As elicited by investigational site staff
Measure: Percentage of participants in Phase 2/3 reporting adverse events Time: From dose 1 through 1 month after the last doseDescription: As elicited by investigational site staff
Measure: Percentage of participants in Phase 2/3 reporting serious adverse events Time: From dose 1 through 6 months after the last doseDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: As elicited by investigational site staff
Measure: Percentage of participants 12-15 years of age in Phase 3 reporting adverse events Time: From dose 1 through 1 month after the last doseDescription: As elicited by investigational site staff
Measure: Percentage of participants 12-15 years of age in Phase 3 reporting adverse events Time: From dose 1 through 6 months after the last doseDescription: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Measure: In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions Time: For 7 days after dose 1 and dose 2Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
Measure: In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events Time: For 7 days after dose 1 and dose 2Description: As measured at the central laboratory
Measure: In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: In Phase 1 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: In Phase 1 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMCs Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: In Phase 1 participants, GMFR in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels from before vaccination to each subsequent time point Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: In Phase 1 participants, GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS CoV 2 (anti-S1 and anti-RBD) binding antibody levels Time: Through 2 years after the final doseDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: As measured at the central laboratory
Measure: GMR of SARS CoV 2 neutralizing titers in the 2 age groups (12-15 years of age to 16-25 years of age) Time: 1 month after the second doseThis study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.
Description: This data will be collected for decisions on subsequent vaccination of an additional open-label sentinel group with the same dose level.
Measure: Number of Participants With Grade 3 Adverse Reactions or any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination Time: Up to 24 hours after vaccination on Day 1Description: This data will be collected for decisions on dose escalation as well as continuation of enrollment at the same dose level in the observer-blind placebo-controlled part of the trial.
Measure: Number of Participants With Grade 3 Adverse Reactions or any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination Time: Up to 60 hours after vaccination on Day 1Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies Time: Baseline and on Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393Description: Measured using an activity assay.
Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies Time: Baseline and on Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393Description: Measured using an activity assay.
Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393Description: Measured using an activity assay.
Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393This study aims to evaluate the safety (in all participants) and reactogenicity (in a subset of participants) of CVnCoV administered as a 2-dose schedule to adult participants 18 years of age or older. The study also aims to assess antibody responses to the receptor-binding domain (RBD) of spike (S) protein of SARS-CoV-2 after 1 and 2 doses of CVnCoV in adults 18 years of age or older included in a subset of participants.
Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Individual SARS-CoV-2 Spike (S) Protein-Specific Antibody Levels in Serum Time: Days 1, 29, 43, 57, 120, 211 and 393Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA). Seroconversion is defined as detectable SARS-CoV-2 RBD of S protein antibodies in the serum of participants who tested seronegative on prior to vaccination on Day 1.
Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike (S) Protein Antibodies Time: Days 1, 29, 43, 57, 120, 211 and 393Description: Seroconversion is defined as detectable SARS-CoV-2 N protein antibodies in the serum of subjects on Day 211 and/or Day 393 of the trial, who tested seronegative at prior to vaccination on Day 1 and Day 43.
Measure: Number of Participants Seroconverting to the Nucleocapsid (N) Protein of SARS-SoV-2 Time: Day 1, 43, 211 and 393Description: Measured by a virus neutralizing assay in a subset of participants.
Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum Time: Days 1, 29, 43, 57, 120, 211 and 393Description: Measured by a virus neutralizing assay in a subset of participants.
Measure: Number of Participants Seroconverting to SARS-CoV-2 Time: Days 1, 29, 43, 57, 120, 211 and 393Description: Measured by a virus neutralizing assay in a subset of participants.
Measure: Individual Serum Antibodies to Spike (S) Protein of SARS-CoV-2 Time: Days 43, 57, 120, 211 and 393The study will enroll up to 60,000 participants in order to evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.
Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate greater than or equal to (>=) 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus Time: 1 Day post-vaccination (Day 2) to end of study (2.1 Years)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease COVID-19 Regardless of Their Serostatus Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate greater than or equal to (>=) 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) Time: 1 Day post-vaccination (Day 2) to end of study (2.1 Years)Description: Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, intensive care unit (ICU) admission, mechanical ventilation, and extracorporeal membrane oxygenation (ECMO), linked to objective measures such as decreased oxygenation, X-ray or CT findings) or linked to any molecularly confirmed, COVID-19 at least 14 days post vaccination will be reported.
Measure: Number of Participants with First Occurrence of COVID-19 Requiring Medical Intervention Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: The viral load of SARS-CoV-2 will be assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs will be used to detect and/or quantify SARS-CoV-2.
Measure: SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants with Molecularly Confirmed, Moderate to Severe/Critical COVID-19 Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Molecularly confirmed mild COVID-19 is defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Mild COVID-19 includes: Fever, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, or chills, without shortness of breath or dyspnea.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Mild COVID-19 Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Molecularly confirmed moderate and severe/critical COVID-19 defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of this protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized case Definition Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: BOD will be evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.
Measure: Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Serologic conversion between baseline and (Day 1; pre-vaccination), Day 71, 6 Months, 1 year post-vaccination using an ELISA and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 nucleocapsid (N) protein will be reported.
Measure: Serologic Conversion Between Baseline and (Day 1; Pre-vaccination), Day 71, 6 Months and 1- Year Post-vaccination using an Enzyme-linked Immunosorbent Assay (ELISA) Time: Between baseline (Day 1; pre-vaccination) and Day 71, 6 Months, 1-Year post-vaccination (up to 52 Weeks)Description: Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) with onset at least 14 days after vaccination (Day 15) to end of Study (2.1 Years) will be reported.
Measure: Number of Participants with First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Measure: Number of Participants with Serious Adverse Events (SAEs) Time: Up to 104 WeeksDescription: MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.
Measure: Number of Participants with Medically-Attended Adverse Events (MAAEs) Time: Up to 6 MonthsDescription: MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
Measure: Number of Participants with Medically-Attended Adverse Events (MAAEs) Leading to Study Discontinuation Time: Up to 104 WeeksDescription: Participants will be asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Measure: Number of Participants with Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination Time: Up to Day 8 (7 Days after first vaccination on Day 1)Description: Participants will be instructed on how to record daily temperature using a thermometer provided for home use. Participants should record the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement is made on any given day, the highest temperature of that day will be recorded in the e-Diary. Fever is defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants will also be instructed on how to note signs and symptoms in the e-Diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.
Measure: Number of Participants with Solicited Systemic AEs During 7 Days Following Vaccination Time: Up to Day 8 (7 Days after first vaccination on Day 1)Description: Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measure: Number of Participants with Unsolicited Local Adverse Events (AEs) During 28 Days Post-vaccination Time: Up to Day 29 (28 Days after first vaccination on Day 1)Description: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralizing antibody titers as assessed by VNA to measure the humoral immune responses will be reported
Measure: SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA) Time: Up to 104 WeeksDescription: SARS-CoV-2 binding antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response will be reported.
Measure: SARS-CoV-2 Binding Antibodies Assessed by ELISA Time: Up to 104 WeeksThis study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of investigational SARS-CoV-2 mRNA vaccine (CVnCoV) at different dose levels and to evaluate the humoral immune response after 1 and 2 dose administrations of CVnCoV.
Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies Time: Day 29Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies Time: Day 43Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum Time: Day 29Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum Time: Day 43Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies Time: Day 29Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies Time: Day 43Description: Measured using an activity assay.
Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies Time: Day 29Description: Measured using an activity assay.
Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies Time: Day 43Description: Measured using an activity assay.
Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum Time: Day 29Description: Measured using an activity assay.
Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum Time: Day 43Description: Measured using an activity assay.
Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies Time: Day 29Description: Measured using an activity assay.
Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies Time: Day 43Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Number of Participants with Solicited Local Adverse Events Following the Booster Vaccine Time: 7 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine Time: 7 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Duration of Solicited Local Adverse Events Following the Booster Vaccine Time: 7 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Number of Participants with Solicited Systemic Adverse Events Following the Booster Vaccine Time: 7 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine Time: 7 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Duration of Solicited Systemic Adverse Events Following the Booster Vaccine Time: 7 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine Following the Booster Vaccine Time: 7 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Number of Participants with Unsolicited Adverse Events Following the Booster Vaccine Time: 28 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Intensity of Unsolicited Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine Time: 28 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine Following the Booster Vaccine Time: 28 days after booster vaccinationDescription: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies Time: Day 57, Day 85, Day 180, Day 208 and Day 393Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum Time: Day 57, Day 85, Day 180, Day 208 and Day 393Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies Time: Day 57, Day 85, Day 180, Day 208 and Day 393Description: Measured using an activity assay.
Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies Time: Day 57, Day 85, Day 180, Day 208 and Day 393Description: Measured using an activity assay.
Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum Time: Day 57, Day 85, Day 180, Day 208 and Day 393Description: Measured using an activity assay.
Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies Time: Day 57, Day 85, Day 180, Day 208 and Day 393This is a phase I, randomized, placebo-controlled, observer-blind study, for evaluation of safety and immunogenicity of SARS-CoV-2 mRNA vaccine (BNT162b1) in Chinese healthy population. After randomization, the trial for each subject will last for approximately 12 months. Screening period is 2 weeks prior to randomization (Day -14 to Day 0), and each dose of either SARS-CoV-2 vaccine (BNT162b1) or placebo will be given intramuscularly (IM).
This is a phase II, randomized, placebo-controlled, observer-blinded study of the safety and immunogenicity of SARS-CoV-2 messenger RNA (mRNA) vaccine (BNT162b2) in Chinese healthy population. After randomization, the trial for each participant will last for approximately 13 months. Screening period is 2 weeks prior to randomization (Day -14 to Day 0), and two doses of either SARS-CoV-2 vaccine (BNT162b2) or placebo will be given intramuscularly (IM) separated by 21 days.
Description: SCR of SARS-CoV-2 serum neutralizing titers at 1-month after dose 2. Seroconversion is defined as ≥4-fold rise from before vaccination to 1-month post dose 2.
Measure: SARS-CoV-2 serum neutralizing titers - Seroconversion rates (SCR) Time: 1 Month after Dose 2Description: Compared with baseline before Vaccination 1, SCR of SARS-CoV-2 serum neutralizing titers at 1 week, 6 and 12 months after dose 2.
Measure: SARS-CoV-2 serum neutralizing titers - SCR Time: 1 Week, 6 and 12 Months after Dose 2Description: GMT of SARS-CoV-2 serum neutralizing titers at 1 week, 6 and 12 months after dose 2.
Measure: SARS-CoV-2 serum neutralizing titers - GMT Time: 1 Week, 6 and 12 Months after Dose 2Description: Compared with baseline before Vaccination 1, SCR of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.
Measure: SARS-CoV-2 anti-S1 immunoglobulin G (IgG) antibody level - SCR Time: 1 Week, 1, 6 and 12 Months after Dose 2Description: GMT of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.
Measure: SARS-CoV-2 anti-S1 IgG antibody level - GMT Time: 1 Week, 1, 6 and 12 Months after Dose 2Description: Compared with baseline before Vaccination 1, the GMFR of SARS-CoV-2 serum neutralizing antibody titers at 1 week, 1, 6 and 12 months after dose 2.
Measure: SARS-CoV-2 serum neutralizing antibody level - Geometric mean fold rise (GMFR) Time: 1 Week, 1, 6 and 12 Months after Dose 2Description: Compared with baseline before Vaccination 1, GMFR of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.
Measure: SARS-CoV-2 anti-S1 IgG antibody level - GMFR Time: 1 Week, 1, 6 and 12 Months after Dose 2Description: Pain at the injection site, redness, and swelling as self-reported on diary cards.
Measure: Percentage of participants reporting local reactions Time: Within 7 Days and 14 Days after each vaccinationDescription: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on diary cards.
Measure: Percentage of participants reporting systemic events Time: Within 7 Days and 14 Days after each vaccinationDescription: Percentage of participants with abnormal hematology laboratory values 1 and 7 days after dose 1, before dose 2, and 7 days after dose 2.
Measure: Hematology laboratory assessments Time: Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2Description: Percentage of participants with abnormal chemistry laboratory values 1 and 7 days after dose 1, before dose 2, and 7 days after dose 2.
Measure: Chemistry laboratory assessments Time: Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2Description: Percentage of participants with grading shifts in hematology laboratory assessments between baseline and 1 and 7 days after dose 1; and before dose 2 and 7 days after dose 2.
Measure: Hematology laboratory assessments Time: Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2Description: Percentage of participants with grading shifts in chemistry laboratory assessments between baseline and 1 and 7 days after dose 1; and before dose 2 and 7 days after dose 2.
Measure: Chemistry laboratory assessments Time: Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2Description: AEs from dose 1 to 1 month after the last dose.
Measure: Adverse events (AEs) Time: From Dose 1 through 1 Month after the last DoseDescription: SAEs from dose 1 to 6 months after the last dose.
Measure: Serious AEs (SAEs) Time: From Dose 1 through 6 Months after the last DoseThe SARS-CoV-2 virus is responsible for the COVID-19 pandemic. The pandemic emerged from Wuhan Province in China in December 2019 and was declared by the WHO Director-General a Public Health Emergency of International Concern on 30 January 2020. In this study, a vaccine developed by IIBR for SARS-CoV-2 virus will be assessed for its safety and potential efficacy in volunteers. The study is comprised of two phases, a dose-escalation phase (phase I) during which subjects (18-55 years old) will be randomly allocated to receive a single administration of IIBR-100 100 at low, mid or high dose or saline or two administrations of IIBR-100 at low dose, or saline, 28 days apart. Based on results obtained during phase I, and cumulative phase I data review, the expansion phase (phase II) will begin, during which larger cohorts as well as elderly age subjects will be randomly allocated to receive a single administration of IIBR-100 at low, mid or high dose or saline, or two administrations of IIBR-100 at low dose (prime-boost) or saline, 28 days apart. The subjects will be followed for a period of up to 12 months post last vaccine administration to assess the safety and efficacy of the vaccine.
Description: Solicited events for 7 days after vaccination. Unsolicited events through 28 days after vaccination. SAEs 365 days after last vaccination New Onset Chronic Medical Condition (NOCMC) or Medically Attended AE (MAAE) 365 days after last vaccination.
Measure: Phase I and II - The number, grade and percentage of study participants who experience any study injection-associated AEs or SAEs. Time: 365 days post last vaccinationDescription: Immunogenicity will be evaluated at the following days: 0, 7±2d, 14±2d, 28±4d, 56±5d, 84±4d, 168±14d and 365±14d after the first vaccination for single-dose groups (prime), and at days 0, 14±2d, 28±4d, 35±4d, 42±4d, 56±5d, 84±4d, 112±14d, 196±14d and 393±14d for the prime-boost groups
Measure: Phase I and II - IIBR-100 Immunogenicity as determined by GMT, GMFR, Seroconversion rates of the neutralizing antibody titers to SARS-CoV-2 at baseline (day 0) and throughout the study Time: 365 days post last vaccinationDescription: Immunogenicity will be evaluated at the following days: 0, 7±2d, 14±2d, 28±4d, 56±5d, 84±4d, 168±14d and 365±14d after the first vaccination for single-dose groups (prime), and at days 0, 14±2d, 28±4d, 35±4d, 42±4d, 56±5d, 84±4d, 112±14d, 196±14d and 393±14d for the prime-boost groups
Measure: Phase I and II - IIBR-100 immunogenicity as determined by GMT, GMFR, Seroconversion rates of the binding antibody titers to SARS-CoV-2 at baseline (day 0) and throughout the study Time: 365 days post last vaccinationDescription: Cellular immunity will be assessed at the following days: 0, 28±4d, 56±5d, 84±4d, 168±14d and 365±14d for single dose groups and at days 0, 56±5d, 84±4d, 112±14d, 196±14d and 393±14d for the prime-boost groups.
Measure: Phase I and II - Cellular immunity as assessed by ELISPOT and ELISA. Time: 365 days post last vaccinationDescription: immunogenicity as determined by GMT, GMFR and seroconversion rates of the neutralizing, and binding, antibody titers to SARS-CoV-2 at 3, 6, 9 and 12 months after first vaccination, in a sub-group of subjects.
Measure: phase I and II - Evaluate the kinetics of antibody decline based on temporal sub-group analyses (at 3, 6, 9, 12 months post first vaccination) Time: 365 daysThe purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort, in healthy adults aged greater than or equal to 18 to less than or equal to 55 years and in adults aged greater than or equal to 65 years in good health with or without stable underlying conditions.
Description: Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after first vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination Time: Day 8 (7 Days after first vaccination on Day 1)Description: Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after second vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination Time: Day 64 (7 Days after second vaccination on Day 57)Description: Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after first vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.
Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination Time: Day 8 (7 Days after first vaccination on Day 1)Description: Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after second vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.
Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination Time: Day 64 (7 Days after second vaccination on Day 57)Description: Number of participants with unsolicited AEs for 28 days after first vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.
Measure: Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination Time: Day 29 (28 Days after first vaccination on Day1)Description: Number of participants with unsolicited AEs for 28 days after second vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.
Measure: Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination Time: Day 85 (28 Days after second vaccination)Description: SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Measure: Cohort 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 1 Year after the Second Vaccination Time: From Day 57 (vaccination 2) up to 1 yearDescription: SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Measure: Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination Time: Day 1 (vaccination 1) up to 6 MonthsDescription: Number of participants with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralizing antibody titers as assessed by VNA to measure the humoral immune responses will be reported.
Measure: Cohorts 1, 2, and 3: Number of Participants With SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA) Time: Up to 38 MonthsDescription: Number of participants with SARS-CoV-2 binding antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response will be reported.
Measure: Cohorts 1, 2, and 3: Number of Participants with SARS-CoV-2 Binding Antibodies Assessed by ELISA Time: Up to 38 MonthsDescription: Number of participants with Th-1 and Th-2 immune responses will be reported. Th1 and Th2 immune responses will be assessed by flow cytometry after SARS-CoV-2 S protein peptide stimulation of peripheral blood mononuclear cells (PBMCs) and intracellular staining [ICS] including cluster of differentiation (CD)-4+/CD-8+, Interferons (INF)-gamma, interleukin [IL] 2, Tumor Necrosis Factor (TNF)-alpha, IL-4, IL-5, IL-13, and/or other Th-1/Th-2 markers.
Measure: Cohorts 1, 2, and 3: Number of Participants with T-helper (Th)-1 and Th-2 Immune Responses as Assessed by Flow Cytometry Time: Up to 38 MonthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports