%0 Journal Article
%T Evaluation of two formulations of adjuvanted RTS, S malaria vaccine in children aged 3 to 5 years living in a malaria-endemic region of Mozambique: a Phase I/IIb randomized double-blind bridging trial
%A Eusebio V Macete
%A Jahit Sacarlal
%A John J Aponte
%A Amanda Leach
%A Margarita M Navia
%A Jessica Milman
%A Caterina Guinovart
%A Inacio Mandomando
%A Yolanda L車pez-P迆a
%A Marc Lievens
%A Alex Owusu-Ofori
%A Marie-Claude Dubois
%A Conor P Cahill
%A Marguerite Koutsoukos
%A Marla Sillman
%A Ricardo Thompson
%A Filip Dubovsky
%A W Ripley Ballou
%A Joe Cohen
%A Pedro L Alonso
%J Trials
%D 2007
%I BioMed Central
%R 10.1186/1745-6215-8-11
%X We performed a phase I/IIb randomized double-blind bridging study in a malaria-endemic region of Mozambique, to compare the safety and immunogenicity of both candidate vaccines with the aim of replacing RTS, S/AS02A with RTS, S/AS02D as the candidate pediatric vaccine. 200 Mozambican children aged 3 to 5 years were randomized 1:1 to receive one of the 2 vaccines according to a 0, 1, 2 month schedule.Both vaccines were safe and had similar reactogenicity profiles. All subjects with paired pre and post-vaccination samples showed a vaccine response with respect to anti-circumsporozoite (CS) antibodies irrespective of initial anti-CS serostatus. Geometric mean titers (GMTs) were 191 EU/ml (95% CI 150每242) in recipients of RTS, S/AS02D compared to 180 EU/ml (95% CI 146每221) in recipients of RTS, S/AS02A. For the anti-hepatitis B surface antigen (HBsAg), all subjects were seroprotected at day 90, and the GMTs were 23978 mIU/ml (95% CI 17896每32127) in RTS, S/AS02D recipients and 17410 mIU/ml (95% CI 13322每22752) in RTS, S/AS02A recipients. There was a decrease in anti-CS GMTs between months 3 and 14 in both groups (191 vs 22 EU/mL in RTS, S/AS02D group and 180 vs 29 EU/mL in RTS, S/AS02A group).Our data show that the RTS, S/AS02D is safe, well tolerated, and demonstrates non-inferiority (defined as upper limit of the 95% confidence interval of the anti-CS GMT ratio of RTS, S/AS02A to RTS, S/AS02D below 3.0) of the antibody responses to circumsporozoite and HBsAg induced by the RTS, S/AS02D as compared to the RTS, S/AS02A.Malaria is still leading the list of killer diseases in Africa. Two million children die annually from this disease [1,2] primarily due to infection with Plasmodium falciparum. Currently, malaria control strategies are chiefly based on the early diagnosis and treatment of infected individuals. While preventive measures such as vector control and insecticide treated bednets remain indispensable, a vaccine is viewed as an essential part of the long-term stra
%U http://www.trialsjournal.com/content/8/1/11