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NCT04889209 · ClinicalTrials.gov registry record · Phase 1
Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 867
- Enrollment target
NCT04889209: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04889209 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 867 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1345% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04889209, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 867 participants
- Enrollment target
Study Summary
A phase 1/2, open-label clinical trial in individuals, 18 years of age and older, who are in good health, have no known history of Coronavirus Disease 2019 (COVID-19) or Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, and meet all other eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of a delayed (\>/=12 weeks) vaccine boost on a range of Emergency Use Authorization (EUA)-dosed COVID-19 vaccines (mRNA-1273, and mRNA-1273.211 manufactured by ModernaTX, Inc.; BNT162b2 manufactured by Pfizer/BioNTech; or Ad26.COV2.S manufactured by Janssen Pharmaceuticals/Johnson \& Johnson). This is an adaptive design and may add arms (and increase sample size) as vaccines are awarded EUA and/or variant lineage spike vaccines are manufactured or become available. Enrollment will occur at up to twelve domestic clinical research sites. This study includes two cohorts. Cohort 1 will include approximately 880 individuals (50 subjects/group; Groups 1E-11E) greater than 18 years of age and older, stratified into two age strata (18-55 years and \>/=56 years) who previously received COVID-19 vaccine at Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at the 100 mcg dose, two vaccinations of BNT162b2 at the 30 mcg dose, or one vaccination of Ad26.COV2.S at the 5x10\^10 vp dose). Groups 15E-17E will enroll 60 subjects, split (approximately evenly) between age strata as able. Those subjects will be offered enrollment into this study \>/=12 weeks after they received the last dose of their EUA vaccine. Subjects will receive a single open-label intramuscular (IM) injection of the designated delayed booster vaccine and will be followed through 12 months after vaccination: 1) Group 1E - previously EUA-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10\^10 vp followed by a 100-mcg dose of mRNA-1273, Group 4E - previously EUA-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10\^10 vp follo
Primary Outcome
Geometric Mean AUC of Antibody Against WA-1 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method. Units are Electrochemiluminescence (ECL) Signal x 1/dilution (integrated).
Interventions
- BIOLOGICAL BNT162b2
- BIOLOGICAL mRNA-1273
- BIOLOGICAL mRNA-1273.222
- BIOLOGICAL Ad26.COV2.S
- BIOLOGICAL mRNA-1273.211
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 867 participants |
| Start Date | 2021-05-28 |
| Est. Completion | 2023-06-16 |
| Phase | Phase 1 |
What the finished NCT04889209 record still lists
NCT04889209 is an interventional study that assigns participants to a tested intervention. The registered 867 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 (1345% higher).
The record links to 0 conditions, and to 5 interventions - of which BNT162b2 is the first listed.
NCT04889209 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04889209 about?
NCT04889209 is a clinical study titled "Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines". A phase 1/2, open-label clinical trial in individuals, 18 years of age and older, who are in good health, have no known history of Coronavirus Disease 2019 (COVID-19) or Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, and meet all other eligibility criteria. This clinical tri...
What is the current status of trial NCT04889209?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 867 participants. The study started on 2021-05-28. Estimated completion is 2023-06-16.
What interventions are being tested in trial NCT04889209?
The interventions under investigation include: BNT162b2 (BIOLOGICAL), mRNA-1273 (BIOLOGICAL), mRNA-1273.222 (BIOLOGICAL), Ad26.COV2.S (BIOLOGICAL), mRNA-1273.211 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04889209?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04889209's enrollment target sits among peer trials
867 11th of 2000 higher than 1,990 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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