Details

Autor(en) / Beteiligte

• 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
• Sigaúque, Betuel
• Sillman, Marla
• Milman, Jessica
• Dubois, Marie-Claude
• Demoitié, Marie-Ange
• Thonnard, Joelle
• Menéndez, Clara
• Ballou, W. Ripley
• Cohen, Joe
• Alonso, Pedro L.

Titel

Long-Term Safety and Efficacy of the RTS,S/AS02A Malaria Vaccine in Mozambican Children

Ist Teil von

• The Journal of infectious diseases, 2009-08, Vol.200 (3), p.329-336

Ort / Verlag

Oxford: The University of Chicago Press

Erscheinungsjahr

2009

Link zum Volltext

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• 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.