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
C2 - 19569964
SN - 0022-1899
VL - 200
SP - 329
EP - 336
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 3
ER -