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Human Neonatal Rotavirus Vaccine (RV3-BB) to Target Rotavirus from Birth
Julie E Bines1, Jarir At Thobari1, Cahya Dewi Satria1
1From the RV3 Rotavirus Vaccine Program, Murdoch Children's Research Institute (J.E.B., A.H., E.W., D.C., J.S., F.J., G.B., K.J.L., G.L.B., K.B., N.B.-S., D.P., R.F.B., C.D.K., J.P.B.), the Department of Paediatrics, University of Melbourne (J.E.B., D.C., K.J.L., G.L.B., R.F.B., C.D.K., J.P.B.), and the Department of Gastroenterology and Clinical Nutrition, Royal Children's Hospital Melbourne (J.E.B., J.S.), Parkville, the Departments of Paediatrics and of Epidemiology and Preventive Medicine, Monash University, and the Department of Infection and Immunity, Monash Children's Hospital, Clayton (J.P.B.), and Medicines Development for Global Health (A.H.) and Global BioSolutions (J.A.), Melbourne - all in Victoria, Australia; the Department of Pharmacology and Therapy (J.A.T.), the Pediatric Research Office, Department of Paediatrics (C.D.S., A.V.I., Y.S.), and the Department of Microbiology (H.N.), Faculty of Medicine, Universitas Gadjah Mada, Yogyakarta, and PT Bio Farma, Bandung (N.S.B.) - all in Indonesia; and the Bill and Melinda Gates Foundation, Seattle (C.D.K.).
Insights
A neonatal rotavirus vaccine (RV3-BB) administered at birth proved effective in preventing severe rotavirus gastroenteritis in Indonesian infants. The neonatal schedule showed a 75% efficacy, offering a promising strategy for early rotavirus prevention.
Area of Science:
- Pediatrics
- Infectious Diseases
- Vaccinology
Background:
- Rotavirus gastroenteritis is a significant global health concern, particularly in neonates.
- Current rotavirus vaccine implementation faces barriers, necessitating novel administration strategies.
- Early prevention through neonatal vaccination may overcome existing challenges in global rotavirus control.
Purpose of the Study:
- To evaluate the efficacy of an oral human neonatal rotavirus vaccine (RV3-BB) in preventing rotavirus gastroenteritis.
- To compare the efficacy of RV3-BB administered on a neonatal schedule versus an infant schedule.
- To assess the safety and immunogenicity of RV3-BB in a randomized controlled trial.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted in Indonesia.
- Healthy newborns received RV3-BB or placebo on either a neonatal (birth, 8, 14 weeks) or infant (8, 14, 18 weeks) schedule.
- Efficacy was assessed based on severe rotavirus gastroenteritis incidence in per-protocol and intention-to-treat populations.
Main Results:
- The neonatal schedule demonstrated 75% efficacy against severe rotavirus gastroenteritis, compared to 51% for the infant schedule.
- Combined efficacy for both schedules was 63% in the per-protocol analysis.
- High vaccine response rates (94-99%) were observed, with similar adverse event profiles across groups. No early intussusception events were reported.
Conclusions:
- The RV3-BB vaccine is efficacious in preventing severe rotavirus gastroenteritis when administered via neonatal or infant schedules in Indonesia.
- The neonatal schedule shows particular promise for early and effective rotavirus prevention.
- The study supports the potential of RV3-BB as a valuable tool in global rotavirus disease control efforts.
Background:
A strategy of administering a neonatal rotavirus vaccine at birth to target early prevention of rotavirus gastroenteritis may address some of the barriers to global implementation of a rotavirus vaccine.
Methods:
We conducted a randomized, double-blind, placebo-controlled trial in Indonesia to evaluate the efficacy of an oral human neonatal rotavirus vaccine (RV3-BB) in preventing rotavirus gastroenteritis. Healthy newborns received three doses of RV3-BB, administered according to a neonatal schedule (0 to 5 days, 8 weeks, and 14 weeks of age) or an infant schedule (8 weeks, 14 weeks, and 18 weeks of age), or placebo. The primary analysis was conducted in the per-protocol population, which included only participants who received all four doses of vaccine or placebo within the visit windows, with secondary analyses performed in the intention-to-treat population, which included all participants who underwent randomization.
Results:
Among the 1513 participants in the per-protocol population, severe rotavirus gastroenteritis occurred up to the age of 18 months in 5.6% of the participants in the placebo group (28 of 504 babies), in 1.4% in the neonatal-schedule vaccine group (7 of 498), and in 2.7% in the infant-schedule vaccine group (14 of 511). This resulted in a vaccine efficacy of 75% (95% confidence interval [CI], 44 to 91) in the neonatal-schedule group (P<0.001), 51% (95% CI, 7 to 76) in the infant-schedule group (P=0.03), and 63% (95% CI, 34 to 80) in the neonatal-schedule and infant-schedule groups combined (combined vaccine group) (P<0.001). Similar results were observed in the intention-to-treat analysis (1649 participants); the vaccine efficacy was 68% (95% CI, 35 to 86) in the neonatal-schedule group (P=0.001), 52% (95% CI, 11 to 76) in the infant-schedule group (P=0.02), and 60% (95% CI, 31 to 76) in the combined vaccine group (P<0.001). Vaccine response, as evidenced by serum immune response or shedding of RV3-BB in the stool, occurred in 78 of 83 participants (94%) in the neonatal-schedule group and in 83 of 84 participants (99%) in the infant-schedule group. The incidence of adverse events was similar across the groups. No episodes of intussusception occurred within the 21-day risk period after administration of any dose of vaccine or placebo, and one episode of intussusception occurred 114 days after the third dose of vaccine in the infant-schedule group.
Conclusions:
RV3-BB was efficacious in preventing severe rotavirus gastroenteritis when administered according to a neonatal or an infant schedule in Indonesia. (Funded by the Bill and Melinda Gates Foundation and others; Australian New Zealand Clinical Trials Registry number, ACTRN12612001282875 .).
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