Name (Synonyms) | Correlation | |
---|---|---|
drug154 | BNT162b1 Wiki | 1.00 |
drug156 | BNT162c2 Wiki | 1.00 |
drug153 | BNT162a1 Wiki | 1.00 |
drug592 | Hydroxychloroquine (HCQ) Wiki | 0.41 |
drug1016 | Placebo Wiki | 0.05 |
Name (Synonyms) | Correlation | |
---|---|---|
D012327 | RNA Virus Infections NIH | 0.35 |
D012141 | Respiratory Tract Infections NIH | 0.16 |
D014777 | Virus Diseases NIH | 0.09 |
D055371 | Acute Lung Injury NIH | 0.08 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.08 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.07 |
D003141 | Communicable Diseases NIH | 0.07 |
D007239 | Infection NIH | 0.05 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0011947 | Respiratory tract infection HPO | 0.16 |
There are 2 clinical trials
This is a Phase 1/2, randomized, placebo-controlled, observer-blind, dose-finding, and vaccine candidate-selection study in healthy adults. The study will evaluate the safety, tolerability, immunogenicity, and potential efficacy of up to 4 different SARS-CoV-2 RNA vaccine candidates against COVID-19: - As a 2-dose or single-dose schedule - At up to 3 different dose levels - In 3 age groups (18 to 55 years of age, 65 to 85 years of age, and 18 to 85 years of age The study consists of 3 stages. Stage 1: to identify preferred vaccine candidate(s), dose level(s), number of doses, and schedule of administration (with the first 15 participants at each dose level of each vaccine candidate comprising a sentinel cohort); Stage 2: an expanded-cohort stage; and Stage 3; a final candidate/dose large-scale stage.
Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Measure: Percentage of participants reporting local reactions Time: For 7 days after dose 1 and dose 2Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
Measure: Percentage of participants reporting systemic events Time: For 7 days after dose 1 and dose 2Description: As elicited by investigational site staff
Measure: Percentage of participants reporting adverse events Time: From dose 1 through 1 month after the last doseDescription: As elicited by investigational site staff
Measure: Percentage of participants reporting serious adverse events Time: From dose 1 through 6 months after the last doseDescription: As measured at the central laboratory
Measure: Percentage of sentinel cohort participants with abnormal hematology and chemistry laboratory values Time: 1 day after dose 1Description: As measured at the central laboratory
Measure: Percentage of sentinel cohort participants with abnormal hematology and chemistry laboratory values Time: 7 days after dose 1Description: As measured at the central laboratory
Measure: Percentage of sentinel cohort participants with abnormal hematology and chemistry laboratory values Time: 7 days after dose 2Description: As measured at the central laboratory
Measure: Percentage of sentinel cohort participants with grading shifts in hematology and chemistry laboratory assessments Time: Between baseline and 1 day after dose 1Description: As measured at the central laboratory
Measure: Percentage of sentinel cohort participants with grading shifts in hematology and chemistry laboratory assessments Time: Between baseline and 7 days after dose 1Description: As measured at the central laboratory
Measure: Percentage of sentinel cohort participants with grading shifts in hematology and chemistry laboratory assessments Time: Between before dose 2 and 7 days after dose 2Description: As measured at the central laboratory
Measure: SARS-CoV-2-specific WT serum neutralizing antibody levels, expressed as GMTs Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: GMFR in SARS-CoV-2-specific WT serum neutralizing titers from before vaccination to each subsequent time point Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: Proportion of participants achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2-specific WT serum neutralizing antibody levels Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: SARS-CoV-2--spike protein-specific binding antibody levels and RBD-specific binding antibody levels, expressed as GMCs Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: Proportion of participants achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2--spike protein-specific binding antibody levels and RBD-specific binding antibody levels Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: GMFR in SARS-CoV-2-spike protein-specific binding antibody levels and RBD-specific binding antibody levels from before vaccination to each subsequent time point Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: GMR of the geometric mean of SARS-CoV-2-specific WT serum neutralizing titers to the geometric mean of SARS CoV 2 (spike protein and RBD) specific binding antibody levels Time: Through 2 years after the final doseDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 incidence Time: From the last dose of study intervention to the end of the study, up to 2 yearsThe trial has two parts: a dose-finding part (Part A) with four dose cohorts (treatment groups) for each vaccine and one pre-defined and one optional dose level for a de-escalation approach and, a second part (Part B) dedicated to recruit expansion cohorts with dose levels which are selected from data generated in Part A. The vaccines BNT162a1, BNT162b1, and BNT162b2 will be administered using a Prime/Boost (P/B) regimen. The vaccine BNT162c2 will be administered using a Single dose (SD) regimen.
Description: For BNT162a1, BNT162b1, BNT162b2 (P/B): occurring up to 21±2 days after the prime immunization.
Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE): Time: 21 days following dose administrationDescription: For BNT162a1, BNT162b1, BNT162b2 (P/B): occurring up to 28±4 days after the boost immunization. For BNT162c2 (SD): The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 days after the immunization.
Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE): Time: 28 days following dose administrationDescription: Functional antibody responses at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2 (P/B): Time: up to 162 days following dose administrationDescription: Fold increase in functional antibody titers 7±1 days and 21±2 days after primary immunization and at 21±2 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2 (P/B): Time: up to 162 days following dose administrationDescription: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2 (P/B): Time: up to 162 days following dose administrationDescription: Functional antibody responses at 7±1 days, 21±2 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administrationDescription: Fold increase in functional antibody titers at 7±1 days, 21±2 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administrationDescription: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days, 21±2 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administration