Safety and Immunogenicity of a Neonatal Rotavirus Vaccine in a Phase 2A study

August 31, 2015

The development of a neonatal rotavirus vaccine has taken a step forward through the joint efforts of Australian and New Zealand researchers, with the publication of a phase 2a clinical trial demonstrating safety and immunogenicity of the RV3-BB human neonatal rotavirus vaccine.

The study was published online on the 27th August in the journal Lancet Infectious Diseases. Medicines Development has been working with the RV3 Rotavirus Vaccine team at the Murdoch Childrens Research Institute (MCRI), with support from Medicines Development’s Director of Development Management Amanda Handley and CEO Mark Sullivan.

Worldwide, rotavirus infection is the leading cause of severe diarrhoea in young children and infants. In addition to its significant contribution to childhood hospitalization from gastroenteritis, the World Health Organization estimates that over 500,000 children under the age of 5 die each year from preventable rotavirus infection, the majority of whom live in developing countries.

Two live attenuated oral rotavirus vaccines, RotaTeq (Merck) and Rotarix (GlaxoSmithKline), are currently licensed worldwide for the prevention of rotavirus in infants from 6 weeks of age. While these vaccines are safe and generally effective, their administration schedule may not provide adequate coverage for infants in regions where the rotavirus burden is high and infections occur early in life. The successful phase 2a study of RV3-BB provides proof-of-concept for vaccination in neonates using a human neonatal rotavirus strain, potentially providing a measure to extend vaccine coverage and uptake.

Continued testing of this promising vaccine candidate is underway in Indonesia in a phase 2b trial to determine efficacy in protecting newborns and infants from gastroenteritis (ACTRN12612001282875).