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 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. 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.
RCT Entities:
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 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. 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.
Authors: N A Cunliffe; S Rogerson; W Dove; B D M Thindwa; J Greensill; C D Kirkwood; R L Broadhead; C A Hart Journal: J Clin Microbiol Date: 2002-04 Impact factor: 5.948
Authors: Margaret H Libonati; Allison F Dennis; Sasirekha Ramani; Sarah M McDonald; Asmik Akopov; Ewen F Kirkness; Gagandeep Kang; John T Patton Journal: J Virol Date: 2014-06-04 Impact factor: 5.103
Authors: Sarah M McDonald; Jelle Matthijnssens; John K McAllen; Erin Hine; Larry Overton; Shiliang Wang; Philippe Lemey; Mark Zeller; Marc Van Ranst; David J Spiro; John T Patton Journal: PLoS Pathog Date: 2009-10-23 Impact factor: 6.823