Trial reportBMC infectious diseases2025
Safety, immunogenicity, persistence and dose evaluation of the CS-2034 mRNA COVID-19 vaccine: a phase II randomized controlled trial in healthy Chinese adults.
Trial report in BMC infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05373472 (A Randomized, Double-blind, Dose-exploring, Placebo-controlled, Multi-center Phase II Clinical Trial Evaluating the Safety and Immunogenicity of COVID-19 mRNA Vaccine in Adults Aged 18 Years and Older), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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A Randomized, Double-blind, Dose-exploring, Placebo-controlled, Multi-center Phase II Clinical Trial Evaluating the Safety and Immunogenicity of COVID-19 mRNA Vaccine in Adults Aged 18 Years and Older
Who cites it
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Authors and funding
16 authors.
Funding
Abstract
backgroundOur objective was to evaluate the safety and immunogenicity of the COVID-19 mRNA vaccine (CS-2034) in Chinese adults, and to determine the optimal dosage with a favorable safety and immunogenicity profile.
methodsThis study was a phase II clinical trial conducted across multiple centers, employing a randomized, double-blinded, dose-exploration, placebo-controlled design which was registered at ClinicalTrials.gov under the identifier NCT05373472 (registration date: May 13, 2022).
resultsA total of 150 participants were randomized into low-dose vaccine, high-dose vaccine, and placebo groups. The vaccine CS-2034 was well tolerated, with adverse reactions largely mild to moderate and comparable across dose groups. Both dose levels induced strong neutralizing antibody responses against the ancestral SARS-CoV-2 strain, with high seroconversion and evidence of antibody persistence over time. In contrast, neutralizing activity against the Omicron BA.1 variant was limited and declined further after the peak response.
conclusionsThe 0.3 mL dose (low-dose vaccine) was selected for further development based on comparable immunogenicity and lower reactogenicity. CLINICAL
trial registrationThe study was registered at ClinicalTrials.gov under the identifier NCT05373472 (registration date: May 13, 2022).
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