Case-Control Study to Assess the Effectiveness of Rotarix® Vaccine in HIV-infected and HIV-uninfected Children in South Africa
Site Principal Investigator:
Heather J. Zar (Department of Paediatrics and Child Health, Red Cross War Memorial Children’s Hospital, UCT)
Study Principal Investigator:
Shabir A. Madhi (National Institute for Communicable Diseases/University of the Witwatersrand/Medical Research Council Respiratory and Meningeal Pathogens Research Unit and Paediatric Infectious Diseases Research Unit)
Ralph J. Diedericks (Department of Paediatrics and Child Health, Red Cross War Memorial Children’s Hospital, UCT)
Study Co-ordinator and Surveillance Officers:
Diarrhoeal disease remains one of the leading causes of young child mortality in the developing world. Rotavirus is recognised as one of the primary pathogens causing dehydrating diarrhoea leading to morbidity and mortality in children under 5 years of age.
In South Africa the monovalent rotavirus virus vaccine, Rotarix® (RV1; GSK Biologicals, Belgium), was first introduced in South Africa as part of the Expanded Program on Immunization (EPI, SA) in 2009. Immunisation is given to infants via 2 oral doses at 6 and 14 weeks.
Whilst vaccine efficacy during clinical trials in South Africa was 78%, this study is currently being conducted to assess the effectiveness of rotavirus vaccine in limiting the overall burden of diarrhoeal disease. Based at the Research Centre for Adolescent and Child Health (REACH) at Red Cross War Memorial Children's Hospital, University of Cape Town this study is part of a national collaborative study to assess the effectiveness of rotavirus vaccine introduction.
To assess the effectiveness of 2 doses of Rotarix® vaccine against severe rotavirus gastroenteritis that requires hospitalisation among HIV uninfected and infected children under 5 years old.
Inclusion criteria comprise all children hospitalised for acute diarrhoea, defined as three or more stools in a 24-hour period, with onset of diarrhoea ≤ 7 days prior to hospital visit and eligible to have received the first rotavirus vaccine (6 weeks) being at least 8 weeks of age. A case-control study was completed at the end of 2013; research currently continues into the surveillance of rotavirus (epidemiology, severity, serotype distribution) as an enteric pathogen at Red Cross Children’s Hospital. Inclusion criteria have been expanded to include all previously eligible children with diarrhoea for less than 14 days.