Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older
Public ClinicalTrials.gov record NCT04537208. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccine Formulations (With or Without Adjuvant) in Healthy Adults 18 Years of Age and Older
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04537208
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 441 participants
Conditions and interventions
Conditions
Interventions
- 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
- Placebo (0.9% normal saline) Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2, 2020
- Primary completion
- Nov 18, 2021
- Completion
- Nov 18, 2021
- Last update posted
- Sep 16, 2025
2020 – 2021
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8400004 | Birmingham | Alabama | 35294 | — |
| Investigational Site Number 8400012 | Rolling Hills Estates | California | 90274 | — |
| Investigational Site Number 8400011 | Hollywood | Florida | 33024 | — |
| Investigational Site Number 8400019 | Melbourne | Florida | 32934 | — |
| Investigational Site Number 8400016 | Boston | Massachusetts | 02115 | — |
| Investigational Site Number 8400002 | Omaha | Nebraska | 68134 | — |
| Investigational Site Number 8400001 | Rochester | New York | 14609 | — |
| Investigational Site Number 8400007 | Rochester | New York | 14642 | — |
| Investigational Site Number 8400008 | Cleveland | Ohio | 44122 | — |
| Investigational Site Number 8400003 | Philadelphia | Pennsylvania | 19104 | — |
| Investigational Site Number 8400014 | Mt. Pleasant | South Carolina | 29464 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04537208, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 16, 2025 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04537208 live on ClinicalTrials.gov.