title: 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.
  
  
  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.
authors.affiliation: Department of Gastroenterology and Clinical Nutrition, Royal Children's Hospital, Victoria, Australia.
authors.forename: G L
authors.initials: GL
authors.lastname: Barnes
authors.forename: J S
authors.initials: JS
authors.lastname: Lund
authors.forename: L
authors.initials: L
authors.lastname: Adams
authors.forename: A
authors.initials: A
authors.lastname: Mora
authors.forename: S V
authors.initials: SV
authors.lastname: Mitchell
authors.forename: A
authors.initials: A
authors.lastname: Caples
authors.forename: R F
authors.initials: RF
authors.lastname: Bishop
mesh_terms: 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*
chemical_list: D000914:Antibodies, Viral; C109545:RV3 rotavirus vaccine; D022243:Rotavirus Vaccines; D014765:Viral Vaccines