Randomized, controlled trial of the long term safety, immunogenicity and efficacy of RTS,S/AS02(D) malaria vaccine in infants living in a malaria-endemic region
Salim Abdulla, Nahya Salim, Francisca Machera, Richard Kamata, Omar Juma, Mwanajaa Shomari, Sulende Kubhoja, Ali Mohammed, Grace Mwangoka, Thomas Aebi, Hassan Mshinda, David Schellenberg, Terrell Carter, Tonya Villafana, Marie-Claude Dubois, Amanda Leach, Marc Lievens, Johan Vekemans, Joe Cohen, W Ripley Ballou Show all
Malaria Journal | BMC | Published : 2013
BACKGROUND: The RTS,S/AS malaria candidate vaccine is being developed with the intent to be delivered, if approved, through the Expanded Programme on Immunization (EPI) of the World Health Organization. Safety, immunogenicity and efficacy of the RTS,S/AS02(D) vaccine candidate when integrated into a standard EPI schedule for infants have been reported over a nine-month surveillance period. This paper describes results following 20 months of follow up. METHODS: This Phase IIb, single-centre, randomized controlled trial enrolled 340 infants in Tanzania to receive three doses of RTS,S/AS02(D) or hepatitis B vaccine at 8, 12, and 16 weeks of age. All infants also received DTPw/Hib (diphtheria an..View full abstract
This study was sponsored by GSK Biologicals SA Belgium, and funded by both GSK Biologicals and the PATH Malaria Vaccine Initiative (MVI). MVI supports the development and testing of several malaria vaccine candidates. MAD, MCD, AL, ML, JV, JC, and WRB are employees of the GlaxoSmithKline group of companies. MAD, MCD, AL, JV, JC and WRB own shares in GSK Biologicals. JC and WRB are listed as the inventors of patented malaria vaccines. However, neither individual holds a patent for a malaria vaccine. TC and TV were, at the time of the study, employees at PATH MVI. DS declares his institution receiving consultancy fees from MVI for other work. MT is a board member of the UBS-Optimus foundation and declares his institution received compensation for his membership of a Novartis scientific advisory board, and reimbursements from the Bill & Melinda Gates Foundation and Wellcome Trust as compensation for travel costs. None of the other authors declare any further potential competing interests.The trial was supported by the PATH Malaria Vaccine Initiative (MVI) and by GSK Biologicals. We thank all the children and parents who participated in this study; the Bagamoyo communities and their leaders; the entire staff at Bagamoyo Research and Training Centre of Ifakara Health Institute, Bagamoyo District Hospital, and the dispensaries in the study area; and Zaria Said and Richard Kamata, study counselors. The staff at the Swiss TPH, Basel, for providing key support to this trial and acting as site partners; Christoph Hatz for serving as a liaison between the trial team and the Swiss institutional review boards; Christine Walliser and Christian Wirz for their administrative and logistic support; Hans-Peter Marti for providing assistance with laboratory procedures; Rahiya Shariff for her coordination of the communications team; our colleagues in other trial sites supported by MVI through the Bill and Melinda Gates Foundation, particularly the team from Centro de Investigacao em Saude de Manhica at Manhica, Mozambique, which provided support and advice for the implementation of the trial; the staff of the Malaria Project Team at GSK Biologicals, particularly Nathalie Annez, Delphine Beauport, Sarah Benns, Issam Jaimai, Isabelle Ramboer, Shantala Rao, Christine Swysen, Marie Chantal Uwamwezi, and Laurence Vigneron. We are grateful to the fruitful exchanges with our colleagues in the various other MVI supported trial sites through the CPTC network and the MCTA initiative of the Bill & Melinda Gates Foundation, particularly the team of Manhica that provided support and advice for building up BRTC-IHI and the implementation of the trial based on their experience with the proof-of concept trial and the staggered approach among infants. Christian Loucq, Melinda Moree, and Regina Rabinovich for their hard work and dedication to the project; Karim Manji for providing continuous support and guidance; Malcolm Molyneux, chair of the data and safety monitoring board, for his instruction and support; Andrew Kitua, director of the National Institute of Health at the Ministry of Health and Social Welfare; and the staff of the Contract Laboratory Services of South Africa for providing invaluable support.