RotaNeo: Rotavirus vaccine in premature babies
Research type
Research Study
Full title
RotaNeo: Evaluation of rotavirus vaccine administration in premature babies in the neonatal unit
IRAS ID
161327
Contact name
Andrew J Pollard
Contact email
Research summary
The main aim of this study is to discover how long rotavirus vaccine is present in the poo of premature babies after vaccination.
Rotavirus is the commonest cause of severe tummy infection in young children, and premature babies are at high risk of serious disease. RV1 rotavirus vaccine is given to all children at 8 weeks and 12 weeks of age. It is given by mouth and can be found in a baby's poo following vaccination. Premature babies often receive their initial vaccines while they are still in hospital in neonatal units. There are no data regarding stool excretion of the RV1 rotavirus vaccine in premature babies - there is a theoretical risk of transmission of the vaccine virus to other babies in the unit. Some countries have therefore advised against immunisation of babies while in the neonatal unit. In the UK, however, the vaccine is being given in neonatal units, enabling evaluation of the vaccine in hospitalised premature babies.
Each baby will have poo samples taken before and after receiving the vaccine. We will also take some blood from these babies to test how they respond to the vaccine.
The study will enrol 10-20 babies from the neonatal unit at the John Radcliffe Hospital, Oxford University Hospitals NHS Trust. The study will take 24 months. Recruitment will occur over approximately 12-18 months, with an additional 6 months to complete the study for the last participant and the laboratory analysis.
In this study we will be able to find out how long premature babies in hospital have rotavirus vaccine in their poo for after vaccination, and this will help to plan a larger study which will provide definitive information on how to use the RV1 rotavirus vaccine in premature babies.
The study is funded by the Medical Research Fund, University of Oxford.
REC name
Wales REC 7
REC reference
14/WA/1148
Date of REC Opinion
11 Sep 2014
REC opinion
Favourable Opinion