Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults
Public ClinicalTrials.gov record NCT04636697. 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
Randomized, Observer-Blind, Placebo-Controlled, Phase 2/3 Study to Assess the Safety, Efficacy, and Immunogenicity of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults 18 Years of Age or Older
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 2/3 study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP has an acceptable immunogenicity and safety profile. The Phase 3 portion is an event-driven, randomized, observer blinded, placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation compared to placebo. Subjects will be followed for safety and immunogenicity for a period of 12 months after the last vaccination.
Study identification
- NCT ID
- NCT04636697
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 30,918 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
- Nov 18, 2020
- Primary completion
- Aug 24, 2021
- Completion
- Apr 29, 2022
- Last update posted
- Apr 5, 2022
2020 – 2022
United States locations
- U.S. sites
- 45
- U.S. states
- 20
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Achieve Clinical Research, LLC dba Accel Research Sites | Birmingham | Alabama | 35216 | — |
| Fiel Family and Sports Medicine/CCT | Tempe | Arizona | 85283 | — |
| Hope Clinical Research | Canoga Park | California | 91303 | — |
| CNS Network | Garden Grove | California | 92845 | — |
| Long Beach Clinical Trial Services Inc. | Long Beach | California | 90806-3221 | — |
| Pharmacology Research Institute | Newport Beach | California | 92660 | — |
| Wr-McCr, Llc | San Diego | California | 92108 | — |
| Ascension Providence Health System | Washington D.C. | District of Columbia | 20017 | — |
| Alliance for Multispecialty Research | Coral Gables | Florida | 33134-4321 | — |
| Research Centers of America | Hollywood | Florida | 33024 | — |
| AppleMed Research Inc | Miami | Florida | 33155 | — |
| Elixia COVID-19 | Palm Beach | Florida | 33410 | — |
| Precision Clinical Research | Sunrise | Florida | 33351 | — |
| Meridian Clinical Research | Savannah | Georgia | 31406 | — |
| ASR, LLC | Nampa | Idaho | 83687 | — |
| Affinity Health | Chicago | Illinois | 60644 | — |
| Meridian Clinical Research | Sioux City | Iowa | 51106 | — |
| Benchmark Research | Covington | Louisiana | 70433 | — |
| Ascension St. John Vaccine Research Unit | Grosse Pointe Woods | Michigan | 48236 | — |
| Methodist Physicians | Fremont | Nebraska | 68130 | — |
| Be Well Clinical Studies, LLC | Lincoln | Nebraska | 68516 | — |
| Meridian Clinical Research LLC | Norfolk | Nebraska | 68701 | — |
| Meridian Clinical Research LLC | Omaha | Nebraska | 68134 | — |
| Forte Family Practice/ CCT Research | Las Vegas | Nevada | 89103 | — |
| Excel Clinical Research | Las Vegas | Nevada | 89109 | — |
| Las Vegas Clinical Trials | North Las Vegas | Nevada | 89030 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Meridian Clinical Research | Endwell | New York | 13760 | — |
| Carolina Institute for Clinical Research | Fayetteville | North Carolina | 28303 | — |
| M3 Wake Research, Inc | Raleigh | North Carolina | 27612 | — |
| Trial Management Associates LLC | Wilmington | North Carolina | 28403 | — |
| Velocity Clinical Research - Cincinnati | Cincinnati | Ohio | 45242 | — |
| Velocity Clinical Research | Cleveland | Ohio | 44122 | — |
| Aventiv Research Inc | Columbus | Ohio | 43213 | — |
| Velocity Clinical Research Providence | Warwick | Rhode Island | 02886 | — |
| Benchmark Research | Austin | Texas | 78705 | — |
| Tekton Research | Austin | Texas | 78745 | — |
| Global Medical Research | Dallas | Texas | 75224 | — |
| Benchmark Research | Fort Worth | Texas | 76135 | — |
| Research Your Health | Plano | Texas | 75093 | — |
| Mt. Olympus Medical Research, LLC | Sugar Land | Texas | 77479 | — |
| Sugar Lakes Family Practice | Sugar Land | Texas | 77479 | — |
| DM Clinical Research/Martin Diagnostic Clinic | Tomball | Texas | 77375 | — |
| South Ogden Family Medicine | Ogden | Utah | 84405 | — |
| Advanced Clinical Research, Inc. | West Jordan | Utah | 84088 | — |
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 46 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04636697, 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 Apr 5, 2022 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04636697 live on ClinicalTrials.gov.