This article is more than 5 years old. Information may no longer be current.
RV3-BB improves rotavirus protection at birth in high-burden regions
Click Here to Manage Email Alerts
The administration of monovalent human neonatal rotavirus vaccine RV3-BB at birth or during infancy is effective, well-tolerated and has the potential to improve rotavirus vaccine coverage in high-burden areas, according to a study published in The Lancet Infectious Diseases.
“Our findings show that the RV3-BB vaccine is well-tolerated and immunogenic when given as a three-dose neonatal or infant schedule,” Julie E. Bines, MD, of the department of pediatrics, at the University of Melbourne, Australia, and colleagues wrote. “The unique characteristics of the human neonatal rotavirus strain make RV3-BB ideal as a vaccine candidate for birth dose administration, which has the potential to improve the effectiveness and safety of rotavirus vaccines in low-income countries.”
The researchers performed a phase 2a randomized, double blind, placebo-controlled, safety and immunogenicity trial at a hospital in New Zealand from January 2012 to April 2014. The study included 89 healthy, full-term infants. Participants were randomly assigned to three study groups: a neonatal schedule group, which received a first dose of RV3-BB at ages 0 to 5 days followed by two doses and a placebo (n = 30); an infant schedule group, which received an initial placebo dose at ages 0 to 5 days followed by three doses of RV3-BB (n = 27); and a placebo group, which received four placebo doses (n = 32).
After three doses of RV3-BB, 90% of the neonatal group displayed a cumulative vaccine take, compared with 13% in the placebo group (P < .0001). Likewise, after three doses of RV3-BB and one placebo, 93% of the infant group displayed a cumulative vaccine take, compared with 25% of the placebo group (P < .0001). Serum rotavirus IgA antibody titers were detected in 63% of the neonatal group and 74% of the infant group.
The researchers said administration of RV3-BB was not related to an increased frequency of adverse events, such as fever and gastrointestinal symptoms, when compared with the placebo group. They also wrote that implementation of a birth dose strategy may have added benefits due to the unique characteristics of neonatal patients.
“This strategy may also increase the proportion of infants completing a full course of a rotavirus vaccine,” Bines and colleagues wrote. “A birth dose strategy could also limit interference to vaccine take, since most newborn babies have a neutral gastric environment and low breast milk intake.”
In a related editorial, Timo Vesikari, MD, PhD, of the Vaccine Research Center at the University of Tampere, Finland, supported Bines and colleagues’ findings, while further examining some of the study’s limitations.
“The whole study is … important in drawing attention to the somewhat neglected issue of neonatal vaccination against rotavirus,” Vesikari wrote. “However, the immunogenicity of the RV3-BB vaccine still seems modest. In infants who received a non-neonatal schedule at 8, 15, and 24 weeks of age, rotavirus IgA response rate after two doses was 50% and after three doses 74%. For comparison, when human G1P rotavirus vaccine, later to become Rotarix (RV1, GlaxoSmithKline), was first tested in Finland the rotavirus IgA response after two doses given at 8 and 16 weeks of age was 96%.” – by David Costill
Disclosures: Bines reports no relevant financial disclosures. Vesikari reports receiving lecture or consultation fees from GlaxoSmithKline, MSD and Sanofi Pasteur MSD. Please see the full study for a list of all other authors’ relevant financial disclosures.
Click Here to Manage Email Alerts