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. Trial registration. ClinicalTrials.gov identifiers NCT00197041 and NCT00323622 .
RCT Entities:
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. Trial registration. ClinicalTrials.gov identifiers NCT00197041 and NCT00323622 .
Authors: Pedro Aide; John J Aponte; Montse Renom; Tacilta Nhampossa; Jahit Sacarlal; Inacio Mandomando; Quique Bassat; Maria Nélia Manaca; Amanda Leach; Marc Lievens; Johan Vekemans; Marie-Claude Dubois; Christian Loucq; W Ripley Ballou; Joe Cohen; Pedro L Alonso Journal: PLoS One Date: 2010-11-04 Impact factor: 3.240
Authors: John N Waitumbi; Samuel B Anyona; Carol W Hunja; Carolyne M Kifude; Mark E Polhemus; Douglas S Walsh; Chris F Ockenhouse; D Gray Heppner; Amanda Leach; Marc Lievens; W Ripley Ballou; Joe D Cohen; Colin J Sutherland Journal: PLoS One Date: 2009-11-17 Impact factor: 3.240