Safety and Immunogenicity of RTS,S/AS02D Malaria Vaccine in Infants.

Abdulla, S; Oberholzer, R; Juma, O; Kubhoja, S; Machera, F; Membi, C; Omari, S; Urassa, A; Mshinda, H; Jumanne, A; Salim, N; Shomari, M; Aebi, T; Schellenberg, DM; Carter, T; Villafana, T; Demoitié, MA; Dubois, MC; Leach, A; Lievens, M; Vekemans, J; Cohen, J; Ballou, WR; Tanner, M; (2008) Safety and Immunogenicity of RTS,S/AS02D Malaria Vaccine in Infants. The New England journal of medicine, 359 (24). pp. 2533-44. ISSN 0028-4793 DOI:

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: The RTS,S/AS malaria vaccine is being developed for delivery through the World Health Organization's Expanded Program on Immunization (EPI). We assessed the feasibility of integrating RTS,S/AS02D into a standard EPI schedule for infants.<br/> : In this phase 2B, single-center, double-blind, controlled trial involving 340 infants in Bagamoyo, Tanzania, we randomly assigned 340 infants to receive three doses of either the RTS,S/AS02D vaccine or the hepatitis B vaccine at 8, 12, and 16 weeks of age. All infants also received a vaccine containing diphtheria and tetanus toxoids, whole-cell pertussis vaccine, and conjugated Haemophilus influenzae type b vaccine (DTPw/Hib). The primary objectives were the occurrence of serious adverse events during a 9-month surveillance period and a demonstration of noninferiority of the responses to the EPI vaccines (DTPw/Hib and hepatitis B surface antigen) with coadministration of the RTS,S/AS02D vaccine, as compared with the hepatitis B vaccine. The detection of antibodies against Plasmodium falciparum circumsporozoite and efficacy against malaria infection were secondary objectives.<br/> : At least one serious adverse event was reported in 31 of 170 infants who received the RTS,S/AS02D vaccine (18.2%; 95% confidence interval [CI], 12.7 to 24.9) and in 42 of 170 infants who received the hepatitis B vaccine (24.7%; 95% CI, 18.4 to 31.9). The results showed the noninferiority of the RTS,S/AS02D vaccine in terms of antibody responses to EPI antigens. One month after vaccination, 98.6% of infants receiving the RTS,S/AS02D vaccine had seropositive titers for anticircumsporozoite antibodies on enzyme-linked immunosorbent assay (ELISA). During the 6-month period after the third dose of vaccine, the efficacy of the RTS,S/AS02D vaccine against first infection with P. falciparum malaria was 65.2% (95% CI, 20.7 to 84.7; P=0.01).<br/> : The use of the RTS,S/AS02D vaccine in infants had a promising safety profile, did not interfere with the immunologic responses to coadministered EPI antigens, and reduced the incidence of malaria infection. ( number, NCT00289185.)<br/>

Item Type: Article
Faculty and Department: Faculty of Infectious and Tropical Diseases > Dept of Disease Control
Research Centre: Centre for Maternal, Reproductive and Child Health (MARCH)
Malaria Centre
Vaccine Centre
PubMed ID: 19064623
Web of Science ID: 261534200005


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