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 oral rotavirus vaccine candidate RV3 in healthy volunteers.


METHODS
Double blind placebo controlled trial of a single 1 mL 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 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.


CONCLUSIONS
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.
Barnes
G L
GL
Department of Gastroenterology and Clinical Nutrition, Royal Children's Hospital, Victoria, Australia.
Lund
J S
JS
Adams
L
L
Mora
A
A
Mitchell
S V
SV
Caples
A
A
Bishop
R F
RF
D000284:Administration, Oral; D000328:Adult; D000914:Antibodies, Viral / Q000032:analysis*; D002675:Child, Preschool; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D012016:Reference Values; D012401:Rotavirus / Q000276:immunology*; D012400:Rotavirus Infections / Q000276:immunology / Q000517:prevention & control*; D022243:Rotavirus Vaccines; D014765:Viral Vaccines / Q000008:administration & dosage*
D000914:Antibodies, Viral; C109545:RV3 rotavirus vaccine; D022243:Rotavirus Vaccines; D014765:Viral Vaccines