Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older
Public ClinicalTrials.gov record NCT04798027. 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 the First-in-Human SARS-CoV-2 mRNA Vaccine Formulation 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 are: * To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last dose. * To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group. The secondary objectives of the study are: * To describe binding antibody profile from Day 1 to Day 387 of each study intervention group. * To describe the neutralizing antibody profile from Day 91 to Day 387 of each study intervention group. * To describe the occurrence of virologically-confirmed coronavirus disease-2019 (COVID-19)-like illness and serologically-confirmed SARS-CoV-2 infection. * To evaluate the correlation/association between antibody responses to SARS-CoV-2 messenger RNA (mRNA) vaccine and the risk of virologically-confirmed COVID-19-like illness and/or serologically-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection.
Study identification
- NCT ID
- NCT04798027
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 182 participants
Conditions and interventions
Conditions
Interventions
- SARS-CoV-2 mRNA vaccine formulation 1 Biological
- SARS-CoV-2 mRNA vaccine formulation 2 Biological
- SARS-CoV-2 mRNA vaccine formulation 3 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
- Mar 11, 2021
- Primary completion
- Jun 26, 2022
- Completion
- Jun 26, 2022
- Last update posted
- Sep 10, 2025
2021 – 2022
United States locations
- U.S. sites
- 12
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number :8400003 | Rolling Hills Estates | California | 90274 | — |
| Investigational Site Number :8400002 | Hollywood | Florida | 33024 | — |
| Investigational Site Number :8400006 | Miami | Florida | 33135 | — |
| Investigational Site Number :8400017 | Iowa City | Iowa | 52242 | — |
| Investigational Site Number :8400007 | Kansas City | Missouri | 64114 | — |
| Investigational Site Number :8400008 | Omaha | Nebraska | 68134 | — |
| Investigational Site Number :8400001 | Rochester | New York | 14609 | — |
| Investigational Site Number :8400010 | Philadelphia | Pennsylvania | 19104 | — |
| Investigational Site Number :8400004 | North Charleston | South Carolina | 29405 | — |
| Investigational Site Number :8400015 | Knoxville | Tennessee | 37920 | — |
| Investigational Site Number :8400009 | Houston | Texas | 77081 | — |
| Investigational Site Number :8400005 | Salt Lake City | Utah | 84107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04798027, 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 10, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04798027 live on ClinicalTrials.gov.