ArticleOpen forum infectious diseases2025
Phase 1 Randomized Controlled Trial of the Safety and Immunogenicity of the SARS-CoV-2 (Omicron BA.5) mRNA-CR-04 Vaccine in Adults 18-49 Years of Age.
Article in Open forum 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 NCT05972993 (Exploratory, First Time in Human), which is not on this map. Cited by 1 paper.
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
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Exploratory, First Time in Human (FTIH), Observer-blind, Randomized, Controlled Study to Evaluate Safety, Reactogenicity and Immunogenicity of Various Doses of GlaxoSmithKline Biologicals SA's (GSK) Investigational Omicron Variant S Glycoprotein (mRNA-CR-04) Vaccine When Administered Intramuscularly in Healthy Adults 18 to 49 Years of Age
Who cites it
1 citing paper in PubMed.
- Immunogenicity and Protection of mRNA Vaccine Encoding Spike Protein of SARS-CoV-2 Omicron-XEC Subvariant.International journal of molecular sciences · 2026Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: This study (NCT05972993) evaluated a novel mRNA vaccine construct using the SARS-CoV-2 BA.5 Spike (S) protein as the model antigen (mRNA-CR-04). Methods: This first-in-human Phase 1, randomized, placebo-controlled trial enrolled 72 participants in Part A (sentinel vaccination and dose escalation) and 42 in Part B (dose exploration). Adult participants 18-49 years of age were randomized in 3 groups to receive one dose of mRNA-CR-04 (either 10, 30, or 100 µg) or placebo (3:1) in Part A, and 3 µg, 10 µg, or placebo (3:3:1) in Part B. Vaccine safety and immunogenicity in terms of neutralizing titers were assessed until 6 months postinvestigational product administration. Results: Solicited adverse events (AEs) were mostly mild to moderate and transient. In Part A, Grade 3 reactogenicity was only observed in the 100 µg group ( Conclusions: The investigational mRNA-CR-04 vaccine was generally well tolerated, and all doses induced a robust immune response against the encoded antigen at doses ranging between 3 and 100 µg. Further investigation of potential vaccine candidates using this novel mRNA platform is warranted.
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Registered trials
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