Long-term safety and efficacy of the RTS,S/AS02A malaria vaccine in Mozambican children

Jahit Sacarlal, Pedro Aide, John J. Aponte, Montse Renom, Amanda Leach, Inácio Mandomando, Marc Lievens, Quique Bassat, Sarah Lafuente, Eusébio Macete, Johan Vekemans, Caterina Guinovart, Betuel Sigaúuque, Marla Sillman, Jessica Milman, Marie Claude Dubois, Marie Ange Demoitié, Joelle Thonnard, Clara Menéndez, W. Ripley BallouJoe Cohen, Pedro L. Alonso

    Research output: Contribution to journalArticle

    Abstract

    Background. We previously reported that the RTS,S/AS02A vaccine had an acceptable safety profile, was immunogenic, and demonstrated efficacy against Plasmodium falciparum malaria disease for 21 months. Methods. We conducted a randomized, controlled, phase 2b trial of RTS,S/AS02A in 2022 Mozambican children aged 1-4 years. We now report safety results for all randomized subjects and vaccine efficacy (VE) findings for children in the Manhiça area over the 45-month surveillance period. Results. During the surveillance period, the VE(2.5-45) (VE over months 2.5-45 of surveillance) against a first or only episode of clinical malaria disease was 30.5% (95% confidence interval [CI], 18.9%-40.4%; P< .001), and the VE (2.5-45) against all episodes was 25.6% (95% CI, 11.9%-37.1%; P< .001 ). When the same period was considered, the VE(2.5-45) for subjects protected against severe malaria was 38.3% (95% CI, 3.4%-61.3%; P = .045). At study month 45, the prevalence of P falciparum was 34% lower in the RTS,S/AS02A group than in the control group (66 [12.2%] of 541 patients vs 101 [18.5%] of 547 patients) (P = .004). Conclusion. These results show evidence that RTS,S/AS02A maintained protection during the 45-month surveillance period, and they highlight the feasibility of developing an effective vaccine against malaria. In combination with other malaria-control measures, such a vaccine could greatly contribute to reducing the intolerable global burden of this disease.

    Original languageEnglish
    Pages (from-to)329-336
    Number of pages8
    JournalJournal of Infectious Diseases
    Volume200
    Issue number3
    DOIs
    Publication statusPublished - 2009

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    Sacarlal, J., Aide, P., Aponte, J. J., Renom, M., Leach, A., Mandomando, I., Lievens, M., Bassat, Q., Lafuente, S., Macete, E., Vekemans, J., Guinovart, C., Sigaúuque, B., Sillman, M., Milman, J., Dubois, M. C., Demoitié, M. A., Thonnard, J., Menéndez, C., ... Alonso, P. L. (2009). Long-term safety and efficacy of the RTS,S/AS02A malaria vaccine in Mozambican children. Journal of Infectious Diseases, 200(3), 329-336. https://doi.org/10.1086/600119