Evaluation of the safety and immunogenicity of the RTS,S/AS01E malaria candidate vaccine when integrated in the expanded program of immunization.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Agnandji Selidji T, Asante Kwaku Poku, Lyimo John, Vekemans Johan, Soulanoudjingar Solange S, Owusu Ruth, Shomari Mwanajaa, Leach Amanda, Fernandes Jose, Dosoo David, Chikawe Maria, Issifou Saadou, Osei-Kwakye Kingsley, Lievens Marc, Paricek Maria, Apanga Stephen, Mwangoka Grace, Okissi Blaise, Kwara Evans, Minja Rose, Lange Jorn, Boahen Owusu, Kayan Kingsley, Adjei George, Chandramohan Daniel, Jongert Erik, Demoitié Marie-Ange, Dubois Marie-Claude, Carter Terrel, Vansadia Preeti, Villafana Tonya, Sillman Marla, Savarese Barbara, Lapierre Didier, Ballou William Ripley, Greenwood Brian, Tanner Marcel, Cohen Joe, Kremsner Peter G, Lell Bertrand, Owusu-Agyei Seth, Abdulla Salim
Аннотация
METHODS: This phase 2, randomized, open, controlled trial conducted in Ghana, Tanzania, and Gabon evaluated the safety and immunogenicity of RTS,S/AS01(E) when coadministered with EPI vaccines. Five hundred eleven infants were randomized to receive RTS,S/AS01(E) at 0, 1, and 2 months (in 3 doses with diphtheria, tetanus, and whole-cell pertussis conjugate [DTPw]; hepatitis B [HepB]; Haemophilus influenzae type b [Hib]; and oral polio vaccine [OPV]), RTS,S/AS01(E) at 0, 1, and 7 months (2 doses with DTPwHepB/Hib+OPV and 1 dose with measles and yellow fever), or EPI vaccines only.
RESULTS: The occurrences of serious adverse events were balanced across groups; none were vaccine-related. One child from the control group died. Mild to moderate fever and diaper dermatitis occurred more frequently in the RTS,S/AS01(E) coadministration groups. RTS,S/AS01(E) generated high anti-circumsporozoite protein and anti-hepatitis B surface antigen antibody levels. Regarding EPI vaccine responses upon coadministration when considering both immunization schedules, despite a tendency toward lower geometric mean titers to some EPI antigens, predefined noninferiority criteria were met for all EPI antigens except for polio 3 when EPI vaccines were given with RTS,S/AS01(E) at 0, 1, and 2 months. However, when antibody levels at screening were taken into account, the rates of response to polio 3 antigens were comparable between groups.
CONCLUSION: RTS,S/AS01(E) integrated in the EPI showed a favorable safety and immunogenicity evaluation. Trial registration. ClinicalTrials.gov identifier: NCT00436007 . GlaxoSmithKline study ID number: 106369 (Malaria-050).