Key result
The novel oral hexavalent rotavirus vaccine was well-tolerated across all age groups with no vaccine-related serious adverse events, and demonstrated immunogenicity in infants.
Why the study?
Rotavirus infections are prevalent and predominantly caused by group A viruses, making immunization in infancy the most effective and economical prevention strategy, but the safety and immunogenicity of a novel hexavalent rotavirus vaccine required evaluation.
Is a novel oral hexavalent rotavirus vaccine safe and immunogenic in healthy adults, toddlers, and infants?
RCT (n=200)
Double-blind
2:1:1 ratio
No
Is a novel oral hexavalent rotavirus vaccine safe and immunogenic in healthy adults, toddlers, and infants?
A novel oral hexavalent rotavirus vaccine demonstrated favorable safety and immunogenicity profiles in a phase I trial, supporting its further clinical development.
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Supports advancement to larger efficacy trials in infants; leaves open questions on long-term protection and real-world performance.
Wu et al. (2021) conducted an RCT in Healthy (n=200). Novel oral hexavalent rotavirus vaccine vs. Placebo was evaluated on Safety (adverse events and serious adverse events) and immunogenicity (anti-rotavirus IgA). The novel oral hexavalent rotavirus vaccine was well-tolerated across all age groups with no vaccine-related serious adverse events, and demonstrated immunogenicity in infants.
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