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 Ballou & 2 others Joe Cohen, Pedro L. Alonso

    Research output: Contribution to journalArticleResearchpeer-review

    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

    Fingerprint

    Malaria Vaccines
    Vaccines
    Safety
    Malaria
    Confidence Intervals
    Falciparum Malaria
    RTS,S-AS02A vaccine
    Control Groups

    Cite this

    Sacarlal, J., Aide, P., Aponte, J. J., Renom, M., Leach, A., Mandomando, I., ... 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
    Sacarlal, Jahit ; Aide, Pedro ; Aponte, John J. ; Renom, Montse ; Leach, Amanda ; Mandomando, Inácio ; Lievens, Marc ; Bassat, Quique ; Lafuente, Sarah ; Macete, Eusébio ; Vekemans, Johan ; Guinovart, Caterina ; Sigaúuque, Betuel ; Sillman, Marla ; Milman, Jessica ; Dubois, Marie Claude ; Demoitié, Marie Ange ; Thonnard, Joelle ; Menéndez, Clara ; Ballou, W. Ripley ; Cohen, Joe ; Alonso, Pedro L. / Long-term safety and efficacy of the RTS,S/AS02A malaria vaccine in Mozambican children. In: Journal of Infectious Diseases. 2009 ; Vol. 200, No. 3. pp. 329-336.
    @article{171a16fb433f425782b355919ef11182,
    title = "Long-term safety and efficacy of the RTS,S/AS02A malaria vaccine in Mozambican children",
    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 Manhi{\cc}a 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.",
    author = "Jahit Sacarlal and Pedro Aide and Aponte, {John J.} and Montse Renom and Amanda Leach and In{\'a}cio Mandomando and Marc Lievens and Quique Bassat and Sarah Lafuente and Eus{\'e}bio Macete and Johan Vekemans and Caterina Guinovart and Betuel Siga{\'u}uque and Marla Sillman and Jessica Milman and Dubois, {Marie Claude} and Demoiti{\'e}, {Marie Ange} and Joelle Thonnard and Clara Men{\'e}ndez and Ballou, {W. Ripley} and Joe Cohen and Alonso, {Pedro L.}",
    year = "2009",
    doi = "10.1086/600119",
    language = "English",
    volume = "200",
    pages = "329--336",
    journal = "Journal of Infectious Diseases",
    issn = "0022-1899",
    publisher = "Oxford University Press",
    number = "3",

    }

    Sacarlal, J, Aide, P, Aponte, JJ, 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, MC, Demoitié, MA, Thonnard, J, Menéndez, C, Ballou, WR, Cohen, J & Alonso, PL 2009, 'Long-term safety and efficacy of the RTS,S/AS02A malaria vaccine in Mozambican children', Journal of Infectious Diseases, vol. 200, no. 3, pp. 329-336. https://doi.org/10.1086/600119

    Long-term safety and efficacy of the RTS,S/AS02A malaria vaccine in Mozambican children. / Sacarlal, Jahit; Aide, Pedro; Aponte, John J.; Renom, Montse; Leach, Amanda; Mandomando, Inácio; Lievens, Marc; Bassat, Quique; Lafuente, Sarah; Macete, Eusébio; Vekemans, Johan; Guinovart, Caterina; Sigaúuque, Betuel; Sillman, Marla; Milman, Jessica; Dubois, Marie Claude; Demoitié, Marie Ange; Thonnard, Joelle; Menéndez, Clara; Ballou, W. Ripley; Cohen, Joe; Alonso, Pedro L.

    In: Journal of Infectious Diseases, Vol. 200, No. 3, 2009, p. 329-336.

    Research output: Contribution to journalArticleResearchpeer-review

    TY - JOUR

    T1 - Long-term safety and efficacy of the RTS,S/AS02A malaria vaccine in Mozambican children

    AU - Sacarlal, Jahit

    AU - Aide, Pedro

    AU - Aponte, John J.

    AU - Renom, Montse

    AU - Leach, Amanda

    AU - Mandomando, Inácio

    AU - Lievens, Marc

    AU - Bassat, Quique

    AU - Lafuente, Sarah

    AU - Macete, Eusébio

    AU - Vekemans, Johan

    AU - Guinovart, Caterina

    AU - Sigaúuque, Betuel

    AU - Sillman, Marla

    AU - Milman, Jessica

    AU - Dubois, Marie Claude

    AU - Demoitié, Marie Ange

    AU - Thonnard, Joelle

    AU - Menéndez, Clara

    AU - Ballou, W. Ripley

    AU - Cohen, Joe

    AU - Alonso, Pedro L.

    PY - 2009

    Y1 - 2009

    N2 - 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.

    AB - 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.

    UR - http://www.scopus.com/inward/record.url?scp=67650697101&partnerID=8YFLogxK

    U2 - 10.1086/600119

    DO - 10.1086/600119

    M3 - Article

    VL - 200

    SP - 329

    EP - 336

    JO - Journal of Infectious Diseases

    JF - Journal of Infectious Diseases

    SN - 0022-1899

    IS - 3

    ER -