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

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

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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.
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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.}",
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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.

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U2 - 10.1086/600119

DO - 10.1086/600119

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SP - 329

EP - 336

JO - Journal of Infectious Diseases

JF - Journal of Infectious Diseases

SN - 0022-1899

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