ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2
Public ClinicalTrials.gov record NCT05329220. 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
Evaluation of the Immunogenicity, Safety, and Tolerability of a Single Dose of ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2: a Phase 3 Trial in Two Parts
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This trial is composed of a randomized, double-blind, active controlled component (Part A) and an open-label, single-arm component (Part B) conducted in parallel. Part A is designed to compare vaccination with a single 100 µg dose of ABNCoV2 to a single 30 µg adult booster dose of Comirnaty (active control) in adult subjects who either previously completed primary vaccination (Cohort 1) or have already received 1 booster dose (Cohort 2) of SARS-CoV-2 locally authorized vaccine(s), and whose last locally authorized SARS-CoV-2 vaccination was at least 3 months prior to the screening visit. Subjects will be randomized in a 1:1 ratio to receive either ABNCoV2 or Comirnaty. Part B is designed to collect ABNCoV2 safety and tolerability data from a larger population of adult subjects, as well as additional immunogenicity data from a subset. Part B involves vaccination with the same single 100 µg dose of ABNCoV2 in the same population of adult subjects as the randomized component, and subjects will similarly be enrolled into 2 cohorts according to whether they have completed primary vaccination only or primary plus booster vaccination.
Study identification
- NCT ID
- NCT05329220
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 4,205 participants
Conditions and interventions
Conditions
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
- Aug 30, 2022 (Actual)
- Primary completion
- Mar 15, 2023 (Actual)
- Completion
- Oct 5, 2023 (Actual)
- Last update posted
- Feb 24, 2025
2022 – 2023
United States locations
- U.S. sites
- 44
- U.S. states
- 18
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Achieve Clinical Research LLC d/b/a Accel Research Sites | Birmingham | Alabama | 35216 | — |
| Arizona Clinical Trials | Mesa | Arizona | 85210 | — |
| Tucson Neuroscience Research - M3 WR | Tucson | Arizona | 85710 | — |
| Wr-Pri, Llc | Los Alamitos | California | 90720 | — |
| PRI, LLC - Newport Beach - M3 WR | Newport Beach | California | 92660 | — |
| FOMAT Medical Research | Oxnard | California | 93030 | — |
| Women's Healthcare Research Corporation | San Diego | California | 92111 | — |
| Medical Center For Clinical Research | San Diego | California | 92120 | — |
| Tekton Research | Fort Collins | Colorado | 80525 | — |
| Clinical Site Partners | Leesburg | Florida | 34748 | — |
| Accel Research Sites | Maitland | Florida | 32751 | — |
| Suncoast Research Group LLC | Miami | Florida | 33135 | — |
| Suncoast Research Associates LLC | Miami | Florida | 33173 | — |
| Clinical Site Partners | Miami | Florida | 33186 | — |
| TrueBlue Clinical Research | Tampa | Florida | 33609 | — |
| Clinical Site Partners | Winter Park | Florida | 32789 | — |
| Atlanta Center for Medical Research - CenExel ACMR | Atlanta | Georgia | 30331 | — |
| Tekton Research | Chamblee | Georgia | 30341 | — |
| Columbus Regional Research Institute at Talbotton | Columbus | Georgia | 31904 | — |
| Accel Research Site - NeuroStudies.net, LLC | Decatur | Georgia | 30030 | — |
| Mount Vernon Clinical Research, LLC | Sandy Springs | Georgia | 30328 | — |
| Meridian Clinical Research, LLC | Savannah | Georgia | 31406 | — |
| AES - DRS - Synexus Clinical Research US, Inc. | Evansville | Indiana | 47714 | — |
| Meridian Clinical Research | Sioux City | Iowa | 51106 | — |
| CBH Health - CenExel CBH | Gaithersburg | Maryland | 20877 | — |
| Sundance Clinical Research | St Louis | Missouri | 63141 | — |
| Meridian Clinical Research , LLC | Grand Island | Nebraska | 68803 | — |
| Meridian Clinical Research LLC | Lincoln | Nebraska | 68510 | — |
| Quality Clinical Research, Inc. | Omaha | Nebraska | 68114 | — |
| Meridian Clinical Research | Omaha | Nebraska | 68134 | — |
| Meridian Clinical Research | Binghamton | New York | 13901 | — |
| Emerging Medical Research, LLC | Durham | North Carolina | 27704 | — |
| Carolina Institute for Clinical Research | Fayetteville | North Carolina | 28303 | — |
| M3 Wake Research, Inc | Raleigh | North Carolina | 27612 | — |
| Meridian Clinical Research, LLC | Cincinnati | Ohio | 45219 | — |
| Tekton Research | Edmond | Oklahoma | 73013 | — |
| ClinSearch, LLC | Chattanooga | Tennessee | 37421 | — |
| Tekton Research | Austin | Texas | 78745 | — |
| Tekton Research | Beaumont | Texas | 77706 | — |
| Global Medical Research | Dallas | Texas | 75224 | — |
| Ventavia Research Group | Fort Worth | Texas | 76104 | — |
| Ventavia Research Group | Houston | Texas | 77008 | — |
| DM Clinical Research | Sugar Land | Texas | 77478 | — |
| Meridian Clinical Research - Family Practice | Portsmouth | Virginia | 23703 | — |
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 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05329220, 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 Feb 24, 2025 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05329220 live on ClinicalTrials.gov.