Phase 1 trial of a candidate rotavirus vaccine (RV3) derived from a human neonate

Abstract

Objective: To conduct a phase 1 safety and tolerability trial of an oral rotavirus vaccine candidate RV3 in healthy volunteers. Methodology: Double blind placebo controlled trial of a single 1 mL oral dose (6.5 × 10⁵ fluorescing focus units [FFU]/mL) in 10 healthy young men, 10 3–4 year old children and 10 3 month old infants with a 4 week surveillance period. The study was undertaken at a children's hospital and nearby community in Melbourne, Australia. Results: All subjects successfully completed the trial. There were no significant side‐effects attributable to the vaccine preparation in any age group. No shedding of vaccine virus was detected by enzyme immunoassay. There was evidence of an. immune response in serum and/or gut secretions in two of five vaccinees in each age group. Conclusion: RV3 rotavirus vaccine appears to be safe and well tolerated. Evidence of immunogenicity in some subjects after a single dose encourages further trials to determine immunogenicity after three doses, after reduction of viral dose, and without prior administration of buffer.