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Name (Synonyms) | Correlation | |
---|---|---|
drug678 | CVnCoV Vaccine Wiki | 0.47 |
drug1469 | High-dose placebo (18-59 years) & Three dose regimen Wiki | 0.33 |
drug1889 | Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen Wiki | 0.33 |
Name (Synonyms) | Correlation | |
---|---|---|
drug3408 | Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group# Wiki | 0.33 |
drug1472 | High-dose placebo (60-85 years) & Two dose regimen Wiki | 0.33 |
drug1470 | High-dose placebo (18-59 years) & Two dose regimen Wiki | 0.33 |
drug3510 | Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14 Wiki | 0.33 |
drug1891 | Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen Wiki | 0.33 |
drug677 | CVnCoV 6 μg Wiki | 0.33 |
drug3745 | avdoralimab Wiki | 0.33 |
drug3517 | Two doses of placebo at the schedule of day 0, 14 #middle-dose group# Wiki | 0.33 |
drug3409 | Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group# Wiki | 0.33 |
drug1893 | Low-dose placebo (18-59 years) & Two dose regimen Wiki | 0.33 |
drug1895 | Low-dose placebo (60-85 years) & Two dose regimen Wiki | 0.33 |
drug1466 | High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen Wiki | 0.33 |
drug676 | CVnCoV 12μg Wiki | 0.33 |
drug2593 | Pneumococcal vaccine Wiki | 0.33 |
drug3519 | Two doses of placebo at the schedule of day 0, 28(middle-dose group) Wiki | 0.33 |
drug3406 | Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28 Wiki | 0.33 |
drug1443 | Hepatitis A vaccine Wiki | 0.33 |
drug1468 | High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen Wiki | 0.33 |
drug3407 | Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28 Wiki | 0.33 |
drug1888 | Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen Wiki | 0.33 |
drug3518 | Two doses of placebo at the schedule of day 0, 28(high-dose group) Wiki | 0.33 |
drug3410 | Three doses of placebo at the schedule of day 0, 14, 28(high-dose group) Wiki | 0.33 |
drug3504 | Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14 Wiki | 0.33 |
drug3511 | Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 Wiki | 0.33 |
drug1465 | High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen Wiki | 0.33 |
drug1892 | Low-dose placebo (18-59 years) & Three dose regimen Wiki | 0.33 |
drug1890 | Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen Wiki | 0.33 |
drug3405 | Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28 Wiki | 0.33 |
drug675 | CVnCoV 12 μg Wiki | 0.33 |
drug1894 | Low-dose placebo (60-85 years) & Three dose regimen Wiki | 0.33 |
drug3516 | Two doses of placebo at the schedule of day 0, 14 #High-dose group# Wiki | 0.33 |
drug928 | Covax-19™ Wiki | 0.33 |
drug1471 | High-dose placebo (60-85 years) & Three dose regimen Wiki | 0.33 |
drug3505 | Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 Wiki | 0.33 |
drug1467 | High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen Wiki | 0.33 |
drug2805 | Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki | 0.30 |
drug370 | BCG-Denmark Wiki | 0.19 |
drug3923 | mRNA-1273 Wiki | 0.19 |
drug2490 | Placebo Wiki | 0.17 |
drug366 | BCG Vaccine Wiki | 0.17 |
drug2985 | Saline Wiki | 0.15 |
Navigate: Correlations HPO
There are 9 clinical trials
The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment. This study is a phase I clinical trial. The investigators intent to evaluate the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) .
Description: Occurrence of adverse reactions post-vaccination
Measure: Safety indexes of adverse reactions Time: 0-7 days post-vaccinationDescription: Occurrence of adverse events post-vaccination
Measure: Safety indexes of adverse events Time: 0-28 days post-vaccinationDescription: Occurrence of serious adverse events post-vaccination
Measure: Safety indexes of SAE Time: 0-28 days, within 6 mouths post-vaccinationDescription: Occurrence of abnormal changes of laboratory safety examinations
Measure: Safety indexes of lab measures Time: pre-vaccination, day 7 post-vaccinationDescription: Geometric mean titer(GMT)of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Measure: Immunogencity indexes of GMT(ELISA) Time: day14,28,month 3,6 post-vaccinationDescription: Geometric mean titer(GMT)of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Measure: Immunogencity indexes of GMT(pseudoviral neutralization test method) Time: day14,28,month 6 post-vaccinationDescription: the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Measure: Immunogencity indexes of seropositivity rates(ELISA) Time: day14,28,month 3,6 post-vaccinationDescription: the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Measure: Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method) Time: day14,28,month 6 post-vaccinationDescription: Geometric mean fold increase(GMI)of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Measure: Immunogencity indexes of GMI(ELISA) Time: day14,28,month 3,6 post-vaccinationDescription: Geometric mean fold increase(GMI)of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Measure: Immunogencity indexes of GMI(pseudoviral neutralization test method) Time: day14,28,month 6 post-vaccinationDescription: Geometric mean concentration(GMC)of anti-Ad5 vector neutralizing antibody responses
Measure: Immunogencity indexes of GMC(Ad5 vector) Time: day、14,28,month3,6 post-vaccinationDescription: Geometric mean fold increase(GMI)of anti-Ad5 vector neutralizing antibody responses
Measure: Immunogencity indexes of GMI(Ad5 vector) Time: day、14,28,month3,6 post-vaccinationDescription: specific cellular immune responses
Measure: Immunogencity indexes of cellular immune Time: day 14, 28,month 6 post-vaccinationDescription: Consistency analysis of S-specific antibodies against 2019 novel coronavirus tested by ELISA against those tested by pseudoviral neutralization test method
Measure: Consistency analysis(ELISA and pseudoviral neutralization test method) Time: day,14,28, month 6 post-vaccinationDescription: Relationship between Geometric mean titer (GMT) of S protein-specific antibodies against 2019 novel coronavirus and vaccine dose among study groups
Measure: Dose-response relationship(Humoral immunity) Time: day14,28,month 3,6 post-vaccinationDescription: Persistence analysis of anti-S protein antibodies among study groups
Measure: Persistence analysis of anti-S protein antibodies Time: day14,28,month 3,6 post-vaccinationDescription: Relationship between the appearance time of S-specific antibodies against 2019 novel coronavirus and the vaccination dose.
Measure: Time-dose-response relationship(Humoral immunity) Time: day14,28,month 3,6 post-vaccinationDescription: Relationship between cellular immune levels against 2019 novel coronavirus and vaccine dose among study groups
Measure: Dose-response relationship( cellular immunity) Time: day 14, 28,month 6 post-vaccinationDescription: Persistence analysis of specific cellular immune response
Measure: Persistence analysis of cellular immuse Time: day 14, 28,month 6 post-vaccinationDescription: Relationship between the appearance time of cellular immunity against 2019 novel coronavirus and the vaccination dose.
Measure: Time-dose-response relationship(cellular immunity) Time: day 14, 28,month 6 post-vaccinationThis study is a phase I /II adaptive clinical trial to evaluate the safety, tolerability and the Immunogenicity of Ad5-nCoV in healthy adults from 18 to <55 and 65 to <85 years of age,with the randomized, observer-blind, dose-escalation design
Description: The occurrence of Solicited AE in all groups within 0-6 days after each vaccination;
Measure: Incidence of the Solicited AE in all groups Time: 0-6 days after each vaccinationDescription: The occurrence of Unsolicited AE in all groups within 0-28 days after each vaccination.
Measure: Incidence of Unsolicited AE in all groups Time: 0-28 days after each vaccinationDescription: The occurrence of Serious adverse events (SAE) in all groups within 6 months after the final vaccination.
Measure: Incidence of Serious adverse events (SAE) in all groups Time: 6 months after the final vaccinationDescription: Geometric mean titer (GMT) of the IgG antibody against SARS-CoV-2 measured on Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group (ELISA method);
Measure: Geometric mean titer (GMT) of the IgG antibody against SARS-CoV-2 (ELISA method); Time: Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: Seroconversion rate (%of subjects with 4-fold or greater increase in antibody level) of the IgG antibody against SARS-CoV-2 measured on Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group (ELISA method );
Measure: Seroconversion rate of the IgG antibody against SARS-CoV-2(ELISA method ) Time: Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: Geometric Mean Increase Ratio (GMI) of the specific antibody against SARS-CoV-2 measured on Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group (ELISA method);
Measure: Geometric Mean Increase Ratio (GMI) of the specific antibody against SARS-CoV-2(ELISA method); Time: Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: Geometric mean titer (GMT) of the neutralizing antibody against SARS-CoV-2 measured on Day 0, Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group (Pseudo-viral neutralization assay)
Measure: Geometric mean titer (GMT) of the neutralizing antibody against SARS-CoV-2(Pseudo-viral neutralization assay) Time: Day 0, Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: Seroconversion rate of the neutralizing antibody against SARS-CoV-2 measured on Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group(Pseudo-viral neutralization assay);
Measure: Seroconversion rate of the neutralizing antibody against SARS-CoV-2(Pseudo-viral neutralization assay) Time: Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: Geometric mean increase ratio (GMI) of neutralizing antibody against SARS-CoV-2 measured on Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group (Pseudo-viral neutralization assay)
Measure: Geometric mean increase ratio (GMI) of neutralizing antibody against SARS-CoV-2 (Pseudo-viral neutralization assay) Time: Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: Geometric Mean Titer (GMT) of the neutralizing antibody against adenovirus type 5 vector measured on Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group;
Measure: Geometric Mean Titer (GMT) of the neutralizing antibody against adenovirus type 5 vector Time: Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: Geometric mean increase ratio (GMI) of the neutralizing antibody against adenovirus type 5 vector measured on Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group
Measure: Geometric mean increase ratio (GMI) of the neutralizing antibody against adenovirus type 5 vector Time: Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: The positive rate of IFN-γ stimulated by S protein overlapping peptide library detected by ELISpot
Measure: cellular immune response by ELISpot Time: on Day 0, Day 14, Day 28 and Day 168 in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: The positive rate of IFN-γ, TNF-α, and IL-2 expressed by CD4+ and CD8+ T lymphocytes stimulated by S protein overlapping peptide library detected by Intracellular Cytokine Staining (ICS);
Measure: cellular immune response by ICS Time: Day 0, Day 14, Day 28 and Day 168 in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose groupThis is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at up to 3 domestic clinical research sites. One hundred and fifty-five subjects will be enrolled into one of thirteen cohorts (10 micrograms [mcg], 25 mcg, 50 mcg, 100 mcg, and 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliters [mL]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post second vaccination (Day 394). Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 5 dosages in healthy adults.
Description: Seroconversion is defined as a 4-fold change in antibody titer from baseline
Measure: Percentage of subjects who seroconverted Time: Day 1 to Day 57This 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 393This 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, single-center, randomized, placebo-controlled, double-blind study, to evaluate safety, tolerability and immunogenicity of a recombinant SARS-CoV-2 vaccine (Sf9 cell) in Chinese healthy population aged 18 years and older. After randomization, the trial for each subject will last for approximately 13 months. Screening period is 1 week prior to randomization (Day -7 to Day -1), and each dose of either SARS-CoV-2 vaccine (Sf9 Cell) or placebo will be given intramuscularly (IM) on Day 0 and Day 28 for a two-dose regimen, or on Day 0, Day 14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 55 years old will be enrolled in adult group, and healthy elderly population who are >55 years old will be enrolled in elderly group. After adult group completes the follow-up 7 days after first vaccination, elderly group will be recruited.
Description: Occurrence of solicited AR in the subjects within 7 days after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.
Measure: Occurrence of adverse reactions (AR) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo. Time: 7 days after each dose.Description: Occurrence of solicited AE in the subjects within 7 days after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.
Measure: Occurrence of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo. Time: 7 days after each dose.Description: Occurrence of subjects experiencing AE associated with recombinant SARS-CoV-2 vaccine (Sf9 cell) up to Day 28.
Measure: Occurrence of AE up to Day 28 after prime and boost vaccination. Time: Day 28 after prime and boost vaccination.Description: The proportion of subjects experiencing SAEs up to Day 28 after prime and boost vaccination.
Measure: The proportion of SAEs up to Day 28 after prime and boost vaccination. Time: Day 28 after prime and boost vaccination.Description: Month 12 after prime and boost vaccination.
Measure: The proportion of SAEs up to Month 12 after prime and boost vaccination. Time: The proportion of subjects experiencing SAEs up to Month 12 after prime and boost vaccination.Description: The proportion of subjects experiencing abnormal markers of hematology, blood chemistry and urine analysis within 7 days before prime vaccination and at Day 3 after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.
Measure: The proportion of abnormal markers of hematology, blood chemistry and urine analysis within 7 days before prime vaccination and at Day 3 after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo. Time: 7 days before prime vaccination and Day 3 after each dose.Description: Geometric mean titer (GMT) of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.
Measure: GMT of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.Description: Four-fold increase in anti-RBD specific antibody titers, as compared to baseline, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.
Measure: Four-fold increase in anti-RBD specific antibody titers, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.Description: Geometric mean fold increase (GMFI) of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.
Measure: GMFI of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.Description: Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody (including pseudovirus and live virus-based SARS-CoV-2 neutralizing antibody assay) at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after prime and boost vaccination.
Measure: GMT of SARS-CoV-2 neutralizing antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.Description: Four-fold increase in SARS-CoV-2 neutralizing antibody titers (including pseudovirus and live virus-based SARS-CoV-2 neutralizing antibody assay), as compared to baseline, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.
Measure: Four-fold increase in SARS-CoV-2 neutralizing antibody titers, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination. Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.Description: Geometric mean fold increase (GMFI) of SARS-CoV-2 neutralizing antibody (including pseudovirus and live virus-based SARS-CoV-2 neutralizing antibody assay) at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.
Measure: GMFI of SARS-CoV-2 neutralizing antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after prime and boost vaccination. Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.Description: Seroconversion rates of IFN-γ stimulated by the overlapping peptide library of S-RBD protein at Day 14, Day 28 after boost vaccination.
Measure: Seroconversion rates of IFN-γ stimulated by the overlapping peptide library of S-RBD protein at Day 14, Day 28 after boost vaccination. Time: Day 14, Day 28 after boost vaccination.This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with different immunization procedures (0, 21 days and 0, 14, 28 days) and doses (20μg/40μg).
Description: Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA)
Measure: Geometric mean (GMT) of specific antibody Time: 1 months after immunization in each study groupDescription: The incidence of adverse reaction (AR)
Measure: The incidence of adverse reaction (AR) Time: 0 to 7 days after vaccination in each study groupDescription: The incidence of adverse events (AE)
Measure: The incidence of adverse events (AE) Time: 0 to 28 days after vaccination in each study groupDescription: The incidence of severe adverse events (SAE)
Measure: The incidence of severe adverse events (SAE) Time: 0 to 28 days after vaccination in each study groupDescription: The incidence of serious adverse events
Measure: The incidence of serious adverse events Time: 6 months after vaccination in each study groupDescription: Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays)
Measure: Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies Time: 1 months after immunization in each study groupDescription: The positive conversion rate of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2
Measure: The positive conversion rate of S-RBD protein-specific antibody Time: 14 days, 30 days after immunization in each study groupDescription: Geometric mean fold increase (GMI) of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2
Measure: Geometric mean fold increase (GMI) of S-RBD protein-specific antibody Time: 14 days, 30 days after immunization in each study groupDescription: Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays)
Measure: Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies Time: 14 days after immunization in each study groupDescription: The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization test)
Measure: The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody Time: 14 days, 30 days after immunization in each study groupDescription: Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies (eucivirus and pseudovirus neutralization assays)
Measure: Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies Time: 14 days, 30 days after immunization in each study groupDescription: The consistency analysis of the specific antibody (ELISA) and the specific neutralizing antibody (euvirus and pseudovirus neutralization assays) against SARS-CoV-2 S-RBD protein
Measure: The consistency analysis of the specific antibody and the specific neutralizing antibody Time: 1 months after immunization in each study groupDescription: The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody in each study groups
Measure: The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody Time: 1 months after immunization in each study groupDescription: The persistence (GMT,GMI,positive conversion rate) of specific antibodies against SARS-CoV-2 S-RBD protein
Measure: The persistence (GMT,GMI,positive conversion rate) of specific antibodies Time: 6 months after vaccination in each study groupDescription: Subtypes of IgG antibodies against the S-RBD protein of SARS-CoV-2 after immunization in each study group
Measure: Subtypes of immunoglobulin G (IgG) antibodies Time: 1 months after immunization in each study groupThis is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 18 years and older. After randomization, the trial for each subject will last for approximately 13 months. Screening period is 1 week prior to randomization (Day -7 to Day -1), and each dose of either SARS-CoV-2 vaccine (CHO Cell) or placebo will be given intramuscularly (IM) on Day 0 and Day 14 for a two-dose regimen, or on Day 0, Day 14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 59 years old will be enrolled in adult group, and healthy elderly population who are >59 years old will be enrolled in elderly group. After adult group completes the follow-up 7 days after first vaccination, elderly group will be recruited.
Description: The units of IL2 and IL6 are both pg/ml
Measure: Changes in serum cytokine (IL2, IL6) levels from baseline after 3 days of each dose Time: 3 days of each doseAlphabetical 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