NCT05373472

Phase II Clinical Trial of COVID-19 mRNA Vaccine in Adults Aged 18 Years and Older

Completed Phase 2 Last updated 4 December 2024

What this trial tests

Phase 2 trial testing COVID-19 mRNA vaccine in COVID-19 in 150 participants. Completed in 21 September 2022.

Timeline

6 July 2022

Primary endpoint
21 September 2022

21 September 2022

Quick facts

Lead sponsor	CanSino Biologics Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	150
Start date	6 July 2022
Primary completion	21 September 2022
Estimated completion	21 September 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 COVID-19 mRNA vaccine in people aged 18 years and older, 300 participants will be enrolled and divided into two groups: low- and high-dose groups. Each dose group (150 people) will be divided into 2 age groups (75 each):18 to 59 years old and ≥ 60 years old. The subjects will be randomized into vaccine group or placebo group in a ratio of 2:1. Subjects will complete 2 doses of vaccination 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 received 0.5 ml of the study vaccine or placebo.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent Advances in Lipid Nanoparticles for Delivery of mRNA.
   Yang L, Gong L, Wang P, Zhao X, et al · · 2022 · cited 105× · PMID 36559175 · DOI 10.3390/pharmaceutics14122682
2. 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
3. Race with virus evolution: The development and application of mRNA vaccines against SARS-CoV-2.
   Lee KM, Lin SJ, Wu CJ, Kuo RL. · · 2023 · cited 9× · PMID 36642222 · DOI 10.1016/j.bj.2023.01.002
4. Advancing mRNA vaccines for infectious diseases: key components, innovations, and clinical progress.
   Li S, Zheng L, Zhong J, Gao X. · · 2025 · cited 8× · PMID 40321006 · DOI 10.1042/ebc20253009
5. 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
6. mRNA Vaccine Technology Beyond COVID-19.
   Oloruntimehin S, Akinyi F, Paul M, Ariyo O. · · 2025 · cited 2× · PMID 40573932 · DOI 10.3390/vaccines13060601
7. Safety, immunogenicity, persistence and dose evaluation of the CS-2034 mRNA COVID-19 vaccine: a phase II randomized controlled trial in healthy Chinese adults.
   Jin Z, Wu J, Huang T, Zhao K, et al · · 2025 · PMID 41267026 · DOI 10.1186/s12879-025-12053-4