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Phase 1 trial of a candidate rotavirus vaccine (RV3) derived from a human neonate
G L Barnes1, J S Lund, L Adams
1Department of Gastroenterology and Clinical Nutrition, Royal Children's Hospital, Victoria, Australia.
Insights
The oral rotavirus vaccine candidate RV3 demonstrated safety and tolerability in a phase 1 trial across all age groups. Further studies are recommended to assess immunogenicity after multiple doses.
Area of Science:
- Vaccinology
- Pediatric Infectious Diseases
- Gastroenterology
Background:
- Rotavirus is a leading cause of severe diarrheal disease in infants globally.
- Development of safe and effective rotavirus vaccines is a public health priority.
- RV3 is an oral rotavirus vaccine candidate undergoing clinical evaluation.
Purpose of the Study:
- To evaluate the safety and tolerability of a single oral dose of the RV3 rotavirus vaccine candidate.
- To assess potential side-effects and viral shedding in healthy volunteers.
- To gather preliminary data on the immunogenicity of RV3.
Main Methods:
- Phase 1, double-blind, placebo-controlled trial.
- Single oral dose of RV3 (6.5 x 10(5) FFU/mL) administered to healthy adults, young children, and infants.
- 4-week surveillance period for safety and adverse events.
- Enzyme immunoassay used to detect vaccine virus shedding.
Main Results:
- All participants completed the trial without significant vaccine-related adverse events.
- No vaccine virus shedding was detected in any participant.
- Evidence of immune response (serum and/or gut secretions) observed in 2 out of 5 vaccinees in each age group.
Conclusions:
- The RV3 rotavirus vaccine candidate appears safe and well-tolerated in a single-dose regimen.
- Preliminary immunogenicity data suggests potential for immune response after one dose.
- Further trials are warranted to optimize dosing and assess immunogenicity after multiple doses.
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.