Abdulla, Salim; Oberholzer, Rolf; Juma, Omar; Kubhoja, Sulende; Machera, Francisca; Membi, Christopher; Omari, Said; Urassa, Alwisa; Mshinda, Hassan; Jumanne, Ajuza; +14 more... Salim, Nahya; Shomari, Mwanjaa; Aebi, Thomas; Schellenberg, David M; Carter, Terrell; Villafana, Tonya; Demoitié, Marie-Ange; Dubois, Marie-Claude; Leach, Amanda; Lievens, Marc; Vekemans, Johan; Cohen, Joe; Ballou, W Ripley; Tanner, Marcel; (2008) Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants. The New England journal of medicine, 359 (24). pp. 2533-2544. ISSN 0028-4793 DOI: https://doi.org/10.1056/NEJMoa0807773
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Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. (ClinicalTrials.gov number, NCT00289185.)
Item Type | Article |
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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 |
ISI | 261534200005 |