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NCT04368728 · ClinicalTrials.gov registry record · Phase 2
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
A Phase 2 study of COVID-19 and SARS CoV 2 Infection, sponsored by BioNTech SE.
- Completed
- Registry status
- Phase 2
- Development phase
- 47,079
- Enrollment target
- 20
- Study locations
NCT04368728 is a Phase 2 study of COVID-19 and SARS CoV 2 Infection that has completed, run by BioNTech SE. The registered enrollment target is 47,079 participants, below the 54,983-participant average among 203 other COVID-19 trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 3 states.
The verdict
NCT04368728, a Phase 2 study of COVID-19 and SARS CoV 2 Infection, has completed, sponsored by BioNTech SE.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47,079 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate: * As a 2-dose (separated by 21 days) schedule; * At various different dose levels in Phase 1; * As a booster; * In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age \[stratified as 12-15, 16-55 or \>55 years of age\]). The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg. Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. This will provide an early assessment of the safety of a third dose of BNT162, as well as its immunogenicity. The assessment of boostability will be further expanded in a subset of Phase 3 participants at selected sites in the US who will receive a third dose of BNT162b2 at 30 µg or a third and potentially a fourth dose of prototype BNT162b2VOC at 30 µg (BNT162b2s01, based upon the South African variant and hereafter referred to as BNT162b2SA). A further subset of Phase 3 participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg. To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL BNT162b2
- BIOLOGICAL BNT162b1
- BIOLOGICAL BNT162b2SA
Study Locations (20)
California
- Anaheim Clinical Trials, LLC - Anaheim
- Collaborative Neuroscience Research, LLC - Long Beach
- Long Beach Clinical Trials Services Inc. - Long Beach
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- National Research Institute - Los Angeles
- Velocity Clinical Research, North Hollywood - North Hollywood
- Paradigm Clinical Research Center - Redding
- Kaiser Permanente Sacramento - Sacramento
- Clinical and Translational Science Center (CTSC) Clinical Research Center (CCRC) - Sacramento
Arizona
- Chinle Comprehensive Health Care Facility - Chinle
- Johns Hopkins Center for American Indian Health - Chinle
- The Pain Center of Arizona - Phoenix
- HOPE Research Institute - Phoenix
- Alliance for Multispecialty Research, LLC - Tempe
- Whiteriver Indian Hospital - Whiteriver
Alabama
- North Alabama Research Center, LLC - Athens
- Birmingham Clinical Research Unit - Birmingham
- Medical Affiliated Research Center - Huntsville
- Optimal Research, LLC - Huntsville
- Alliance for Multispecialty Research, LLC - Mobile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47,079 participants |
| Start Date | 2020-04-29 |
| Est. Completion | 2023-02-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04368728
The ClinicalTrials.gov registry entry for NCT04368728 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 47,079 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 54,983-participant average among 203 other COVID-19 trials with a reported enrollment target (14% lower). The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT04368728 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT04368728 about?
NCT04368728 is a clinical study titled "Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals". This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and effica...
What is the current status of trial NCT04368728?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47,079 participants. The study started on 2020-04-29. Estimated completion is 2023-02-10.
What conditions does trial NCT04368728 study?
This clinical trial studies the following conditions: COVID-19, SARS CoV 2 Infection.
What interventions are being tested in trial NCT04368728?
The interventions under investigation include: Placebo (OTHER), BNT162b2 (BIOLOGICAL), BNT162b1 (BIOLOGICAL), BNT162b2SA (BIOLOGICAL).
Who is sponsoring clinical trial NCT04368728?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04368728 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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