PHASE-1 TRIAL OF A CANDIDATE ROTAVIRUS VACCINE (RV3) DERIVED FROM A HUMAN NEONATE

Objective: To conduct a phase 1 safety and tolerability trial of an or al rotavirus vaccine candidate RV3 in healthy volunteers. Methodology: Double blind placebo controlled trial of a single 1 mt oral dose (6.5 x 10(5) 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 survei llance period. The study was undertaken at a children's hospital and n earby community in Melbourne, Australia. Results: All subjects success fully completed the trial. There were no significant side-effects attr ibutable to the vaccine preparation in any age group, No shedding of v accine virus was detected by enzyme immunoassay. There was evidence of an immune response in serum and/or gut secretions in two of five vacc inees in each age group. Conclusion: RV3 rotavirus vaccine appears to be safe and well tolerated. Evidence of immunogenicity in some subject s after a single dose encourages further trials to determine immunogen icity after three doses, after reduction of viral dose, and without pr ior administration of buffer.