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    Immunogenicity

    This report considers only clinical trials that are associated with COVID-19 vaccines.

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (44)


    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

    Correlated MeSH Terms (3)


    Name (Synonyms) Correlation
    D011014 Pneumonia NIH 0.24
    D045169 Severe Acute Respiratory Syndrome NIH 0.20
    D018352 Coronavirus Infections NIH 0.16

    Correlated HPO Terms (1)


    Name (Synonyms) Correlation
    HP:0002090 Pneumonia HPO 0.24

    Clinical Trials

    Navigate: Correlations   HPO

    There are 9 clinical trials


    1 A Single-center,Open-label,Dose-escalating Phase I Clinical Trial to Evaluate Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Healthy Adults Aged 18-60 Years Old

    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) .

    NCT04313127
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

    Primary Outcomes

    Description: Occurrence of adverse reactions post-vaccination

    Measure: Safety indexes of adverse reactions

    Time: 0-7 days post-vaccination

    Secondary Outcomes

    Description: Occurrence of adverse events post-vaccination

    Measure: Safety indexes of adverse events

    Time: 0-28 days post-vaccination

    Description: Occurrence of serious adverse events post-vaccination

    Measure: Safety indexes of SAE

    Time: 0-28 days, within 6 mouths post-vaccination

    Description: Occurrence of abnormal changes of laboratory safety examinations

    Measure: Safety indexes of lab measures

    Time: pre-vaccination, day 7 post-vaccination

    Description: 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-vaccination

    Description: 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-vaccination

    Description: 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-vaccination

    Description: 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-vaccination

    Description: 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-vaccination

    Description: 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-vaccination

    Description: 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-vaccination

    Description: 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-vaccination

    Description: specific cellular immune responses

    Measure: Immunogencity indexes of cellular immune

    Time: day 14, 28,month 6 post-vaccination

    Other Outcomes

    Description: 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-vaccination

    Description: 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-vaccination

    Description: 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-vaccination

    Description: 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-vaccination

    Description: 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-vaccination

    Description: Persistence analysis of specific cellular immune response

    Measure: Persistence analysis of cellular immuse

    Time: day 14, 28,month 6 post-vaccination

    Description: 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-vaccination
    2 A Randomized, Observer-Blind, Dose-escalation Phase I/II Clinical Trial of Ad5-nCoV Vaccine in Healthy Adults From 18 to <85 Years of Age in Canada

    This 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

    NCT04398147
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
    2. Biological: Placebo

    Primary Outcomes

    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 vaccination

    Description: 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 vaccination

    Description: 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 vaccination

    Secondary Outcomes

    Description: 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 group

    Description: 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 group

    Description: 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 group

    Description: 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 group

    Description: 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 group

    Description: 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 group

    Description: 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 group

    Description: 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 group

    Description: 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 group

    Description: 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 group
    3 Phase I, Open-Label, Dose-Ranging Study of the Safety and Immunogenicity of 2019-nCoV Vaccine (mRNA-1273) in Healthy Adults

    This 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.

    NCT04283461
    Conditions
    1. COVID-19
    2. COVID-19 Immunisation
    Interventions
    1. Biological: mRNA-1273

    Primary Outcomes

    Measure: Frequency of solicited local reactogenicity adverse events (AEs)

    Time: Through 7 days post-vaccination

    Measure: Frequency of any medically-attended adverse events (MAAEs)

    Time: Day 1 to Day 394

    Measure: Frequency of any new-onset chronic medical conditions (NOCMCs)

    Time: Day 1 to Day 394

    Measure: Frequency of any serious adverse events (SAEs)

    Time: Day 1 to Day 394

    Measure: Frequency of any unsolicited adverse events (AEs)

    Time: Through 28 days post-vaccination

    Measure: Frequency of solicited systemic reactogenicity adverse events (AEs)

    Time: Through 7 days post-vaccination

    Measure: Grade of any unsolicited adverse events (AEs)

    Time: Through 28 days post-vaccination

    Measure: Grade of solicited local reactogenicity adverse events (AEs)

    Time: Through 7 days post-vaccination

    Measure: Grade of solicited systemic reactogenicity adverse events (AEs)

    Time: Through 7 days post-vaccination

    Secondary Outcomes

    Measure: Geometric mean fold rise (GMFR) in IgG titer from baseline

    Time: Day 1 to Day 57

    Measure: Geometric mean titer (GMT) of antibody

    Time: Day 57

    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 57
    4 COVID-19: A Phase 1, Partially Blind, Placebo-controlled, Dose Escalation, First-in-human, Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity After 1 and 2 Doses of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV Administered Intramuscularly in Healthy Adults

    This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.

    NCT04449276
    Conditions
    1. Severe Acute Respiratory Syndrome
    2. Coronavirus
    3. SARS-CoV-2
    4. COVID-19
    Interventions
    1. Biological: CVnCoV Vaccine
    2. Drug: Placebo
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    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 1

    Description: 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 1

    Measure: Number of Participants with Solicited Local Adverse Events

    Time: 7 days after vaccination

    Measure: Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale

    Time: 7 days after vaccination

    Measure: Duration of Solicited Local Adverse Events

    Time: 7 days after vaccination

    Measure: Number of Participants with Solicited Systemic Adverse Events

    Time: 7 days after vaccination

    Measure: Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale

    Time: 7 days after vaccination

    Measure: Duration of Solicited Systemic Adverse Events

    Time: 7 days after vaccination

    Measure: Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine

    Time: 7 days after vaccination

    Measure: Number of Participants with Unsolicited Adverse Events

    Time: 28 days after vaccination

    Measure: Intensity of Unsolicited Adverse Events Assessed by the Investigator

    Time: 28 days after vaccination

    Measure: Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine

    Time: 28 days after vaccination

    Measure: Number of Participants with One or More Serious Adverse events (SAEs)

    Time: Baseline to Day 393

    Measure: Number of Participants with One or More Serious Adverse events (SAEs) Considered Related to Trial Vaccine

    Time: Baseline to Day 393

    Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs)

    Time: Baseline to Day 393

    Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine

    Time: Baseline to Day 393

    Secondary Outcomes

    Description: 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 393

    Description: 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 393

    Description: 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 393

    Description: 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 393

    Description: 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 393

    Description: 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 393
    5 A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Clinical Study Evaluating the Safety and Immunogenicity of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adult Health Care Workers in Mainz (Germany)

    This 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.

    NCT04674189
    Conditions
    1. Coronavirus
    2. Covid19
    3. SARS-CoV-2
    4. Severe Acute Respiratory Syndrome
    Interventions
    1. Biological: CVnCoV Vaccine
    2. Drug: Placebo
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Measure: Number of Participants with Medically-attended Adverse Events

    Time: Day 29 to Day 211

    Measure: Intensity of Medically-attended Adverse Events per Investigator's Assessment

    Time: Day 29 to Day 211

    Measure: Number of Participants with Medically-attended Adverse Events Considered Related to Trial Vaccine

    Time: Day 29 to Day 211

    Measure: Number of Participants with One or More Serious Adverse Events (SAEs)

    Time: Day 29 to Day 393

    Measure: Intensity of Serious Adverse Events (SAEs) per Investigator's Assessment

    Time: Day 29 to Day 393

    Measure: Number of Participants with One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine

    Time: Day 29 to Day 393

    Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs)

    Time: Day 29 to Day 393

    Measure: Intensity of Adverse Events of Special Interest (AESIs) per Investigator's Assessment

    Time: Day 29 to Day 393

    Measure: Number of Participants with One or More Serious Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine

    Time: Day 29 to Day 393

    Measure: Number of Participants with Death due to a Serious Adverse Event (SAE)

    Time: Day 29 to Day 393

    Measure: Number of Participants with Adverse Events (AEs) Leading to Vaccine Withdrawal or Study Disctontinuation

    Time: Day 29 to Day 393

    Measure: Number of Participants with Solicited Local Adverse Events

    Time: 7 days after vaccination

    Measure: Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale

    Time: 7 days after vaccination

    Measure: Duration of Solicited Local Adverse Events

    Time: 7 days after vaccination

    Measure: Number of Participants with Solicited Systemic Adverse Events

    Time: 7 days after vaccination

    Measure: Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale

    Time: 7 days after vaccination

    Measure: Duration of Solicited Systemic Adverse Events

    Time: 7 days after vaccination

    Measure: Number of Participants with Unsolicited Adverse Events

    Time: 28 days after vaccination

    Measure: Intensity of Unsolicited Adverse Events per the Investigator's Assessment

    Time: 28 days after vaccination

    Measure: Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine

    Time: 28 days after vaccination

    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 393

    Description: 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 393

    Secondary Outcomes

    Measure: Number of Participants that Contract COVID-19 of Any Severity

    Time: Day 1 to Day 393

    Measure: Number of Participants that Contract Mild, Moderate, Severe and Moderate to Severe COVID-19

    Time: Day 1 to Day 393

    Description: 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 393

    Measure: Burden of Disease (BoD) Score Based on First Episodes of Virologically-confirmed Cases of COVID-19

    Time: Day 1 to Day 393

    Description: 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 393

    Description: 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 393

    Description: 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 393
    6 COVID-19: A Phase 2a, Partially Observer-blind, Multicenter, Controlled, Dose-confirmation Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults >60 Years of Age and 18 to 60 Years of Age

    This 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.

    NCT04515147
    Conditions
    1. Coronavirus
    2. Covid19
    3. SARS-CoV-2
    4. Severe Acute Respiratory Syndrome
    Interventions
    1. Biological: CVnCoV 6 μg
    2. Biological: CVnCoV 12 μg
    3. Biological: Hepatitis A vaccine
    4. Biological: Pneumococcal vaccine
    5. Biological: CVnCoV 12μg
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Measure: Number of Participants with Solicited Local Adverse Events

    Time: 7 days after vaccination

    Measure: Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale

    Time: 7 days after vaccination

    Measure: Duration of Solicited Local Adverse Events

    Time: 7 days after vaccination

    Measure: Number of Participants with Solicited Systemic Adverse Events

    Time: 7 days after vaccination

    Measure: Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale

    Time: 7 days after vaccination

    Measure: Duration of Solicited Systemic Adverse Events

    Time: 7 days after vaccination

    Measure: Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine

    Time: 7 days after vaccination

    Measure: Number of Participants with Unsolicited Adverse Events

    Time: 28 days after vaccination

    Measure: Intensity of Unsolicited Adverse Events per the FDA Toxicity Grading Scale

    Time: 28 days after vaccination

    Measure: Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine

    Time: 28 days after vaccination

    Measure: Number of Participants with One or More Serious Adverse Events (SAEs)

    Time: Baseline to Day 393

    Measure: Number of Participants with One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine

    Time: Baseline to Day 393

    Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs)

    Time: Baseline to Day 393

    Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine

    Time: Baseline to Day 393

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies

    Time: Day 29

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies

    Time: Day 43

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum

    Time: Day 29

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum

    Time: Day 43

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies

    Time: Day 29

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies

    Time: Day 43

    Description: Measured using an activity assay.

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies

    Time: Day 29

    Description: Measured using an activity assay.

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies

    Time: Day 43

    Description: Measured using an activity assay.

    Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum

    Time: Day 29

    Description: Measured using an activity assay.

    Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum

    Time: Day 43

    Description: Measured using an activity assay.

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies

    Time: Day 29

    Description: Measured using an activity assay.

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies

    Time: Day 43

    Secondary Outcomes

    Description: 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 vaccination

    Description: 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 vaccination

    Description: 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 vaccination

    Description: 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 vaccination

    Description: 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 vaccination

    Description: 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 vaccination

    Description: 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 vaccination

    Description: 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 vaccination

    Description: 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 vaccination

    Description: 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 vaccination

    Description: 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 393

    Description: 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 393

    Description: 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 393

    Description: 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 393

    Description: 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 393

    Description: 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 393
    7 Safety, Tolerability and Immunogenicity of a Recombinant SARS-CoV-2 Vaccine (Sf9 Cell) in Chinese Healthy Population Aged 18 Years and Older: A Phase I, Single-center, Randomized, Placebo-controlled, Double-blind Study

    This 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.

    NCT04530656
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28
    2. Biological: Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28
    3. Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28
    4. Biological: Two doses of placebo at the schedule of day 0, 28(middle-dose group)
    5. Biological: Two doses of placebo at the schedule of day 0, 28(high-dose group)
    6. Biological: Three doses of placebo at the schedule of day 0, 14, 28(high-dose group)

    Primary Outcomes

    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.

    Secondary Outcomes

    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.
    8 A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱ Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 Years and Above

    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).

    NCT04640402
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen
    2. Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen
    3. Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen
    4. Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen
    5. Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen
    6. Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen
    7. Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen
    8. Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen
    9. Biological: Low-dose placebo (18-59 years) & Two dose regimen
    10. Biological: Low-dose placebo (18-59 years) & Three dose regimen
    11. Biological: High-dose placebo (18-59 years) & Two dose regimen
    12. Biological: High-dose placebo (18-59 years) & Three dose regimen
    13. Biological: Low-dose placebo (60-85 years) & Two dose regimen
    14. Biological: Low-dose placebo (60-85 years) & Three dose regimen
    15. Biological: High-dose placebo (60-85 years) & Two dose regimen
    16. Biological: High-dose placebo (60-85 years) & Three dose regimen

    Primary Outcomes

    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 group

    Description: The incidence of adverse reaction (AR)

    Measure: The incidence of adverse reaction (AR)

    Time: 0 to 7 days after vaccination in each study group

    Secondary Outcomes

    Description: The incidence of adverse events (AE)

    Measure: The incidence of adverse events (AE)

    Time: 0 to 28 days after vaccination in each study group

    Description: 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 group

    Description: The incidence of serious adverse events

    Measure: The incidence of serious adverse events

    Time: 6 months after vaccination in each study group

    Description: 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 group

    Description: 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 group

    Description: 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 group

    Description: 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 group

    Description: 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 group

    Description: 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 group

    Other Outcomes

    Description: 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 group

    Description: 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 group

    Description: 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 group

    Description: 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 group
    9 Safety and Immunogenicity of a Recombinant COVID-19 Vaccine (CHO Cell) in Healthy Population Aged 18 Years and Older: A Phase I Study

    This 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.

    NCT04636333
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14
    2. Biological: Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28
    3. Biological: Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14
    4. Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28
    5. Biological: Two doses of placebo at the schedule of day 0, 14 #middle-dose group#
    6. Biological: Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group#
    7. Biological: Two doses of placebo at the schedule of day 0, 14 #High-dose group#
    8. Biological: Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group#

    Primary Outcomes

    Measure: The proportion of adverse reactions (AR) up to Day 28 after prime and boost vaccination of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.

    Time: 28 days after first dose

    Secondary Outcomes

    Measure: The proportion of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.

    Time: 7 days after each dose

    Measure: The proportion of abnormal markers of hematology, blood chemistry and urine analysis within 3 days after each dose of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo

    Time: 3 days after each dose

    Measure: The proportion of serious adverse events up to Month 12 after prime and boost vaccination.

    Time: Month 12 after prime and boost vaccination

    Measure: The proportion of neutralizing antibody positive conversion rate, positive rate, GMT and GMI at Day 14, Day 21, Day 28, Day 42 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 vaccination program#

    Time: Day 14, Day 21, Day 28, Day 42 after prime vaccination

    Measure: The proportion of IgG antibody positive rate at Day 14, Day 21, Day 28, Day 42 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 vaccination program#

    Time: Day 14, Day 21, Day 28, Day 42 after prime vaccination

    Measure: The proportion of neutralizing antibody positive conversion rate, positive rate, GMT and GM at Day 28, Day 35, Day 42, Day 56 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 ,Day 28 vaccination program#

    Time: Day 28, Day 35, Day 42, Day 56 after prime vaccination

    Measure: The proportion of IgG antibody positive rate at Day 28, Day 35, Day 42, Day 56 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 ,Day 28 vaccination program#

    Time: Day 28, Day 35, Day 42, Day 56 after prime vaccination

    Other Outcomes

    Measure: The proportion of IFN-γ secreted by T cells at Day 14 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo using ELISpot detection method

    Time: Day 14 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo

    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 dose

    Measure: The proportion of neutralizing antibody and the GMT up to Month 3 after the whole process of vaccination

    Time: Month 3 after the whole process of vaccination

    Measure: The proportion of neutralizing antibody and the GMT up to Month 6 after the whole process of vaccination

    Time: Month 6 after the whole process of vaccination

    Measure: The proportion of neutralizing antibody and the GMT up to Month12 after the whole process of vaccination

    Time: Month 12 after the whole process of vaccination

    No related HPO nodes (Using clinical trials)


    HPO

    Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


    No related HPO nodes (Using clinical trials)


    Reports

    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  

    Interventions

    4,818 reports on interventions/drugs

    MeSH

    706 reports on MeSH terms

    HPO

    306 reports on HPO terms

    All Terms

    Alphabetical index of all Terms

    Google Colab

    Python example via Google Colab Notebook