Safety, tolerability and immunogenicity of a quadrivalent recombinant norovirus vaccine (Pichia pastoris) in participants six weeks of age or older: Phase I/IIa trial.

ABSTRACT: Noroviruses are the leading cause of epidemic acute gastroenteritis and foodborne diarrheal disease in humans. Here, a randomized, double-blind, multi-cohort, placebo-controlled clinical trial was performed to determine the candidate vaccine's safety and immunogenicity. The experimental framework incorporated an initial Phase I age/dose-escalation stage followed by a Phase IIa dose-expansion component. A total of 580 participants (five groups: 6 weeks to 23 months, 2-5 years, 6-17 years, 18-59 years, and ≥60 years) were randomized into 13 groups to receive intramuscular injections of either a placebo (aluminium-containing or aluminium-free) or vaccine formulation (low-dose or high-dose) on days 0, 30 and 60. The safety outcomes included the incidence of all adverse events within 0-30 days

SUBMITTER: Chen G 

PROVIDER: S-EPMC12498370 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature