Clinical Trial of COVID-19 Vaccine（SARS-CoV-2 Variant(Omicron BA.5) mRNA Vaccine） in Participants Aged 18 Years and Over

Summary

This is a single-center, randomized, blinded, placebo-controlled clinical trial to evaluate the protective efficacy, safety and immunogenicity of one dose of the SARS-CoV-2 variant (Omicron BA.5) mRNA vaccine in people aged 18 years and older who had received two or three doses of inactivated COVID-19 vaccine.

Timeline

Start

2023-01-04

Primary completion

2023-09

Completion

2023-11

Outcome

Met primary endpoint

paper showing a vaccine efficacy of 51.9% (95% CI, 31.3% to 66.4%). PMID 38903523 ↗

Publications

• Vetter VM, Kurth T, Konigorski S. Evaluation of easy-to-implement anti-stress interventions in a series of N-of-1 trials: study protocol of the anti-stress intervention among physicians study. Front Psychiatry. 2024 Aug 23;15:1420097. doi: 10.3389/fpsyt.2024.1420097. eCollection 2024.
• Emadi Torghabeh A, Aledavood SA, Soltani E, Akbari Oryani M, Akhlaghi S, Hosseini S, Fani Pakdel A, Taghizadeh Kermani A, Anvari K, Shahidsales S, Bahadorian S, Mashreghi Moghaddam S. Pathologic response evaluation of localized or locally advanced esophageal carcinoma to induction chemotherapy followed by preoperative concurrent chemotherapy and hypofractionated radiotherapy: a clinical trial. Front Oncol. 2024 Aug 19;14:1439730. doi: 10.3389/fonc.2024.1439730. eCollection 2024.
• Zhou H, Zheng H, Peng Y, Su Y, Yu X, Wang W, Li S, Ding Y, Jiao S, Wang Y, Zhu X, Luo L, Dong Z, Liu L, Zhang F, Wu Q, Li J, Zhu F. Efficacy, safety, and immunogenicity of SARS-CoV-2 mRNA vaccine (Omicron BA.5) LVRNA012: a randomized, double-blind, placebo-controlled phase 3 trial. Front Immunol. 2024 Jun 6;15:1407826. doi: 10.3389/fimmu.2024.1407826. eCollection 2024.

Drugs

Indications