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NCT05373485
Phase I Clinical Trial of COVID-19 mRNA Vaccine in Adults Aged 18 Years and Older
Phase 1 trial testing COVID-19 mRNA vaccine in COVID-19 in 43 participants. Completed in 8 August 2022.
8 August 2022
Quick facts
| Lead sponsor | CanSino Biologics Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 43 |
| Start date | 17 May 2022 |
| Primary completion | 8 August 2022 |
| Estimated completion | 8 August 2022 |
| Sites | 3 locations across China |
Drugs / interventions tested
- COVID-19 mRNA vaccine — full drug profile →
- Placebo
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
CanSino Biologics Inc. — full company profile →
Who can join
18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the safety and immunogenicity of the COVID-19 mRNA vaccine in people aged 18 years and older, 80 participants will be enrolled and divided into two groups: low- and high-dose groups. Each dose group will be divided into 2 age groups (20 people each):18 to 59 years old and ≥ 60 years old. Subjects will be randomized into vaccine group or placebo group in a ratio of 3:1. Subjects will receive 2 doses of either vaccine or placebo on Day 0 and Day 21, in which the low-dose group will received 0.3 ml of the study vaccine or placebo, and the high dose group will receive 0.5 ml of the study vaccine or placebo.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Nanoparticle technology for mRNA: Delivery strategy, clinical application and developmental landscape.
Li X, Qi J, Wang J, Hu W, et al · · 2024 · cited 47× · PMID 38169577 · DOI 10.7150/thno.84291 -
Research progress of mRNA vaccines for infectious diseases.
Zhang Z, Du J, Zhang D, Han R, et al · · 2025 · cited 5× · PMID 40847375 · DOI 10.1186/s40001-025-03060-x -
mRNA Vaccine Technology Beyond COVID-19.
Oloruntimehin S, Akinyi F, Paul M, Ariyo O. · · 2025 · cited 2× · PMID 40573932 · DOI 10.3390/vaccines13060601 -
Safety and immunogenicity of the COVID-19 mRNA vaccine CS-2034: A randomized, double-blind, dose-exploration, placebo-controlled multicenter Phase I clinical trial in healthy Chinese adults.
Jin Z, Wu J, Wang Y, Huang T, et al · · 2023 · cited 2× · PMID 37898410 · DOI 10.1016/j.jinf.2023.10.012
Verify or expand the search:
- PubMed search for NCT05373485
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of COVID-19 mRNA vaccine
Trials testing the same drug.
- NCT06374394 — A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and To · Phase 3 · completed
- NCT05938075 — Study of VXCO-100, a SARS-CoV Candidate Vaccine, in Adults in the Republic of South Africa · Phase 1 · completed
- NCT05373472 — Phase II Clinical Trial of COVID-19 mRNA Vaccine in Adults Aged 18 Years and Older · Phase 2 · completed
- NCT05144139 — A Phase I/II Clinical Trial in Healthy People Aged 18 Years and Above · Phase 1, PHASE2 · 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 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 NCT05373485 (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 December 2024
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/NCT05373485.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing