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NCT04537208 · ClinicalTrials.gov registry record · Phase 1
Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older
A Phase 1 study of COVID-19 (Healthy Volunteers), sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 441
- Enrollment target
- 11
- Study locations
NCT04537208: Completed Phase 1 study of COVID-19 (Healthy Volunteers), sponsored by Sanofi Pasteur, a Sanofi Company.
NCT04537208 is a Phase 1 study of COVID-19 (Healthy Volunteers) that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 441 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (635% higher). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04537208, a Phase 1 study of COVID-19 (Healthy Volunteers), has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 441 participants
- Enrollment target
- 11
- Study locations
Study Summary
The primary objectives of the study were: * To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group. * To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last injection. The secondary objectives of the study are: * To describe binding antibody profile at Day 1, Day 22, Day 36, Day 181 (Cohort 1) or Day 202 (Cohort 2), and Day 366 (Cohort 1) or Day 387 (Cohort 2) of each study intervention group. * To describe the neutralizing antibody profile at Day 181 (Cohort 1) or Day 202 (Cohort 2) and at Day 366 (Cohort 1) and Day 387 (Cohort 2) of each study intervention group. * To describe the occurrence of virologically-confirmed coronavirus disease (COVID-19)-like illness and serologically-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. * To evaluate the correlation / association between antibody responses to SARS-CoV-2 Recombinant Protein and the risk of virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.
Primary Outcome
GMTs of SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.
Conditions Studied
Interventions
- BIOLOGICAL CoV2 preS dTM-AF03 (low-dose)
- BIOLOGICAL CoV2 preS dTM-AF03 (high-dose)
- BIOLOGICAL CoV2 preS dTM-AS03 (low-dose)
- BIOLOGICAL CoV2 preS dTM-AS03 (high-dose)
- BIOLOGICAL CoV2 preS dTM (high-dose) without adjuvant
Study Locations (11)
Florida
- Investigational Site Number 8400011 - Hollywood
- Investigational Site Number 8400019 - Melbourne
New York
- Investigational Site Number 8400001 - Rochester
- Investigational Site Number 8400007 - Rochester
Alabama
- Investigational Site Number 8400004 - Birmingham
California
- Investigational Site Number 8400012 - Rolling Hills Estates
Massachusetts
- Investigational Site Number 8400016 - Boston
Nebraska
- Investigational Site Number 8400002 - Omaha
Ohio
- Investigational Site Number 8400008 - Cleveland
Pennsylvania
- Investigational Site Number 8400003 - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 441 participants |
| Start Date | 2020-09-03 |
| Est. Completion | 2021-11-19 |
| Phase | Phase 1 |
What the finished NCT04537208 record still lists
NCT04537208 is an interventional study that assigns participants to a tested intervention. The registered 441 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (635% higher).
The record links to 1 condition, with COVID-19 (Healthy Volunteers) appearing as the primary indexed condition, and to 5 interventions - of which CoV2 preS dTM-AF03 (low-dose) is the first listed.
NCT04537208 lists 11 locations in 9 states (Florida, New York, Alabama).
Frequently Asked Questions
What is clinical trial NCT04537208 about?
NCT04537208 is a clinical study titled "Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older". The primary objectives of the study were: * To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group. * To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last injection. The...
What is the current status of trial NCT04537208?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 441 participants. The study started on 2020-09-03. Estimated completion is 2021-11-19.
What conditions does trial NCT04537208 study?
This clinical trial studies the following conditions: COVID-19 (Healthy Volunteers).
What interventions are being tested in trial NCT04537208?
The interventions under investigation include: CoV2 preS dTM-AF03 (low-dose) (BIOLOGICAL), CoV2 preS dTM-AF03 (high-dose) (BIOLOGICAL), CoV2 preS dTM-AS03 (low-dose) (BIOLOGICAL), CoV2 preS dTM-AS03 (high-dose) (BIOLOGICAL), CoV2 preS dTM (high-dose) without adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT04537208?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04537208 being conducted?
This trial has 11 study locations across Alabama, California, Florida, Massachusetts, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04537208's enrollment target sits among peer trials
441 61st of 2000 higher than 1,940 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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