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NCT04591717
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
Phase 1 trial testing hAd5-S-Fusion+N-ETSD vaccine in COVID-19 in 34 participants. Completed in 18 January 2023.
20 April 2022
Quick facts
| Lead sponsor | ImmunityBio, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 34 |
| Start date | 19 October 2020 |
| Primary completion | 20 April 2022 |
| Estimated completion | 18 January 2023 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- hAd5-S-Fusion+N-ETSD vaccine — full drug profile →
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
ImmunityBio, Inc. — full company profile →
Who can join
Adults 18 to 55, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a phase 1b, open-label study in adult healthy subjects. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Coronavirus vaccine development: from SARS and MERS to COVID-19.
Li YD, Chi WY, Su JH, Ferrall L, et al · · 2020 · cited 242× · PMID 33341119 · DOI 10.1186/s12929-020-00695-2 -
COVID-19 vaccines: rapid development, implications, challenges and future prospects.
Kashte S, Gulbake A, El-Amin Iii SF, Gupta A. · · 2021 · cited 240× · PMID 33677814 · DOI 10.1007/s13577-021-00512-4 -
Adenoviral vector vaccine platforms in the SARS-CoV-2 pandemic.
Mendonça SA, Lorincz R, Boucher P, Curiel DT. · · 2021 · cited 223× · PMID 34354082 · DOI 10.1038/s41541-021-00356-x -
COVID-19 vaccine: A recent update in pipeline vaccines, their design and development strategies.
Rawat K, Kumari P, Saha L. · · 2021 · cited 169× · PMID 33245898 · DOI 10.1016/j.ejphar.2020.173751 -
COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials.
Yan ZP, Yang M, Lai CL. · · 2021 · cited 89× · PMID 33923054 · DOI 10.3390/ph14050406 -
Mucosal Vaccines, Sterilizing Immunity, and the Future of SARS-CoV-2 Virulence.
Focosi D, Maggi F, Casadevall A. · · 2022 · cited 73× · PMID 35215783 · DOI 10.3390/v14020187 -
Mucosal vaccines for SARS-CoV-2: triumph of hope over experience.
Pilapitiya D, Wheatley AK, Tan HX. · · 2023 · cited 71× · PMID 37146404 · DOI 10.1016/j.ebiom.2023.104585 -
Advances in gene-based vaccine platforms to address the COVID-19 pandemic.
Pushparajah D, Jimenez S, Wong S, Alattas H, et al · · 2021 · cited 66× · PMID 33422546 · DOI 10.1016/j.addr.2021.01.003
Verify or expand the search:
- PubMed search for NCT04591717
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of hAd5-S-Fusion+N-ETSD vaccine
Trials testing the same drug.
- NCT04710303 — COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults · Phase 1 · completed
Other recruiting trials for COVID-19
Currently open trials in the same condition.
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- NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
- NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
- NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
- NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting
Other ImmunityBio, Inc. trials
Trials by the same sponsor.
- NCT07492888 — Nogapendekin Alfa-Inbakicept and iNKT Cells for Critically Ill Adults With Severe Community-Acquired Pneumonia (With or · Phase 2 · not yet recruiting
- NCT07524257 — ResQ1010-NSCLC: NAI + Chemoimmunotherapy vs Chemoimmunotherapy for First-Line Advanced/Metastatic NSCLC · Phase 3 · not yet recruiting
- NCT07492875 — Study of Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia · Phase 3 · not yet recruiting
- NCT07488884 — Open-Label, Phase 1 Clinical Trial of Neoadjuvant Nogapendekin Alfa Inbakicept, Sotevtamab, and Zabadinostat in Combinat · Phase 1 · not yet recruiting
- NCT07125872 — Study of Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04591717 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ImmunityBio, Inc.
- Last refreshed: 28 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04591717.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing