Last reviewed · How we verify
NCT04313127: CTCOVID-19
Phase I Clinical Trial of a COVID-19 Vaccine in 18-60 Healthy Adults
Phase 1 trial testing Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in COVID-19 in 108 participants. Completed in 20 February 2021.
20 January 2021
Quick facts
| Lead sponsor | CanSino Biologics Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 108 |
| Start date | 16 March 2020 |
| Primary completion | 20 January 2021 |
| Estimated completion | 20 February 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) — full drug profile →
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
CanSino Biologics Inc. — full company profile →
Who can join
Adults 18 to 60, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment. This study is a phase I clinical trial. The investigators intent to evaluate the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) .
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Immunology of COVID-19: Current State of the Science.
Vabret N, Britton GJ, Gruber C, Hegde S, et al · · 2020 · cited 1248× · PMID 32505227 · DOI 10.1016/j.immuni.2020.05.002 -
Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial.
Zhu FC, Li YH, Guan XH, Hou LH, et al · · 2020 · cited 1017× · PMID 32450106 · DOI 10.1016/s0140-6736(20)31208-3 -
COVID-19 Vaccine: A comprehensive status report.
Kaur SP, Gupta V. · · 2020 · cited 482× · PMID 32800805 · DOI 10.1016/j.virusres.2020.198114 -
COVID-19: Transmission, prevention, and potential therapeutic opportunities.
Lotfi M, Hamblin MR, Rezaei N. · · 2020 · cited 447× · PMID 32474009 · DOI 10.1016/j.cca.2020.05.044 -
Impact of Vaccines; Health, Economic and Social Perspectives.
Rodrigues CMC, Plotkin SA. · · 2020 · cited 394× · PMID 32760367 · DOI 10.3389/fmicb.2020.01526 -
Diarrhea During COVID-19 Infection: Pathogenesis, Epidemiology, Prevention, and Management.
D'Amico F, Baumgart DC, Danese S, Peyrin-Biroulet L. · · 2020 · cited 357× · PMID 32278065 · DOI 10.1016/j.cgh.2020.04.001 -
Overview of Immune Response During SARS-CoV-2 Infection: Lessons From the Past.
Shah VK, Firmal P, Alam A, Ganguly D, et al · · 2020 · cited 317× · PMID 32849654 · DOI 10.3389/fimmu.2020.01949 -
Ongoing Clinical Trials for the Management of the COVID-19 Pandemic.
Lythgoe MP, Middleton P. · · 2020 · cited 247× · PMID 32291112 · DOI 10.1016/j.tips.2020.03.006
Verify or expand the search:
- PubMed search for NCT04313127
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Trials testing the same drug.
- NCT05169008 — A Study to Evaluate the Safety and Immunogenicity of Ad5-nCoV and Ad5-nCoV-IH in CoronaVac Immunized Children and Adoles · Phase 3 · terminated
- NCT04840992 — Phase I/II Clinical Trial of Recombinant Novel Coronavirus (COVID-19) Vaccine (Adenovirus Type 5 Vector) for Inhalation · Phase 1, PHASE2 · completed
- NCT04566770 — A Clinical Trial of A COVID-19 Vaccine Named Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) · Phase 2 · completed
- NCT04526990 — Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above · Phase 3 · completed
- NCT04540419 — Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Against COVID-19 · Phase 3 · completed
Other recruiting trials for COVID-19
Currently open trials in the same condition.
- NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
- 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 CanSino Biologics Inc. trials
Trials by the same sponsor.
- NCT07017777 — A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infant · Phase 3 · recruiting
- NCT06708286 — A Clinical Trials of Adsorbed Cell-free DPT Vaccine (Five-component) · Phase 2, PHASE3 · active not recruiting
- NCT06700148 — A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 7 to 17 Year Olds · Phase 3 · active not recruiting
- NCT06120751 — A Clinical Trial to Evaluate the Safety and Immunogenicity of a Single Dose of Adsorbed Tetanus Vaccine in a Population · Phase 3 · completed
- NCT06101173 — A Study to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) in Health · Phase 1 · completed
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 NCT04313127 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 CanSino Biologics Inc.
- Last refreshed: 4 August 2021
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/NCT04313127.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing