Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure
Public ClinicalTrials.gov record NCT04642638. 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
Phase 2/3 Randomized, Blinded, Placebo-Controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of INO-4800, a Prophylactic Vaccine Against COVID-19 Disease, Administered Intradermally Followed by Electroporation in Adults at High Risk of SARS-CoV-2 Exposure
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent coronavirus disease 2019 (COVID-19) in participants at high risk of exposure to severe acute respiratory syndrome coronavirus - 2 (SARS-CoV-2). The Phase 2 segment will evaluate immunogenicity and safety in approximately 400 participants at two dose levels across three age groups. Safety and immunogenicity information from the Phase 2 segment will be used to determine the dose level for the Phase 3 efficacy segment of the study involving approximately 7116 participants.
Study identification
- NCT ID
- NCT04642638
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 1,307 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 30, 2020 (Actual)
- Primary completion
- Sep 13, 2022 (Actual)
- Completion
- Sep 13, 2022 (Actual)
- Last update posted
- Dec 20, 2023
2020 – 2022
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Synexus Clinical Research US, Inc - Phoenix Southeast | Chandler | Arizona | 85224 | — |
| Central Phoenix Synexus Clinical Research | Phoenix | Arizona | 85020 | — |
| AMR Tempe | Tempe | Arizona | 85283 | — |
| Optimal Research, LLC | San Diego | California | 92108 | — |
| AMR South Florida | Coral Gables | Florida | 33134 | — |
| Clinical Research Trials of Florida, Inc | Tampa | Florida | 33607 | — |
| AMR Lexington | Lexington | Kentucky | 40509 | — |
| Walter Reed Army Institute of Research | Silver Spring | Maryland | 20910 | — |
| Ascension St. John Hospital | Detroit | Michigan | 48236 | — |
| AMR Kansas City | Kansas City | Missouri | 64114 | — |
| AMR, Clinical Research Consortium- Las Vegas | Las Vegas | Nevada | 89119 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Tekton Research | San Antonio | Texas | 78229 | — |
| DM Clinical Research | Tomball | Texas | 78229 | — |
| Advanced Clinical Research | 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 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04642638, 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 Dec 20, 2023 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04642638 live on ClinicalTrials.gov.