Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants
| Autor: | Marie Ange Demoitié, Rolf Oberholzer, Joe Cohen, Marie-Claude Dubois, Amanda J. Leach, Hassan Mshinda, Ajuza Jumanne, Thomas Aebi, Marc Lievens, Nahya Salim, Salim Abdulla, Johan Vekemans, Alwisa Urassa, Francisca Machera, Terrell Carter, David Schellenberg, Tonya Villafana, Omar Juma, Said Omari, W. Ripley Ballou, Christopher Membi, Mwanjaa Shomari, Marcel Tanner, Sulende Kubhoja |
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| Jazyk: | angličtina |
| Rok vydání: | 2008 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Hepatitis B vaccine Plasmodium falciparum Protozoan Proteins Antibodies Protozoan Kaplan-Meier Estimate Double-Blind Method Malaria Vaccines parasitic diseases Medicine Animals Humans Malaria Falciparum Hepatitis B Surface Antigens business.industry Malaria vaccine Diphtheria RTS S Infant General Medicine medicine.disease Vaccination Immunization Immunology Bacterial Vaccines Pertussis vaccine Female business Malaria medicine.drug |
| ISSN: | 0028-4793 |
| Popis: | 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.) |
| Databáze: | OpenAIRE |
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