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Efficacy of the RTS,S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: randomised controlled trial.

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Title: Efficacy of the RTS,S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: randomised controlled trial.
Authors: Alsonso, Pedro L., Sacarlal, Jahit, Aponte, John J., Leach, Amanda, Macete, Eusebio, Milman, Jessica, Mandomando, Inacio, Spiessens, Bart, Guinovart, Caterina, Espasa, Mateu, Bassat, Quique, Aide, Pedro, Ofori-Anyinam, Opokua, Navia, Margarita M., Corachan, Sabine, Ceuppens, Marc, Dubois, Marie-Claude, Demoitié, Marie-Ange, Dubovsky, Filip, Menéndez, Clara
Source: Lancet. 10/16/2004, Vol. 364 Issue 9443, p1411-1420. 10p. 2 Diagrams, 3 Charts, 3 Graphs.
Subjects: Malaria, Vaccine research, Preventive medicine, Plasmodium falciparum, Immunization of children, Prevention of communicable diseases, Drug efficacy, Clinical trials, Health outcome assessment, Vaccination
Geographic Terms: Africa
Abstract: Background Development of an effective malaria vaccine could greatly contribute to disease control. RTS,S/AS02A is a pre-erythrocytic vaccine candidate based on Plasmodium falciparum circumsporozoite surface antigen. We aimed to assess vaccine efficacy, immunogenicity, and safety in young African children. Methods We did a double-blind, phase IIb, randomised controlled trial in Mozambique in 2022 children aged 1--4 years. The study included two cohorts of children living in two separate areas which underwent different follow-up schemes. Participants were randomly allocated three doses of either RTS,S/AS02A candidate malaria vaccine or control vaccines. The primary endpoint, determined in cohort 1 (n=1605), was time to first clinical episode of P falciparum malaria (axillary temperature 37.5°C and P falciparum asexual parasitaemia >2500 per L) over a 6-month surveillance period. Efficacy for prevention of new infections was determined in cohort 2 (n=417). Analysis was per protocol. Findings 115 children in cohort 1 and 50 in cohort 2 did not receive all three doses and were excluded from the perprotocol analysis. Vaccine efficacy for the first clinical episodes was 29.9% (95% CI 11.0--44.8; p=0.004). At the end of the 6-month observation period, prevalence of P falciparum infection was 37% lower in the RTS,S/AS02A group compared with the control group (11.9% vs 18.9%; p=0.0003). Vaccine efficacy for severe malaria was 57.7% (95% CI 16.2--80.6; p=0.019). In cohort 2, vaccine efficacy for extending time to first infection was 45.0% (31.4--55.9; p<0.0001). Interpretation The RTS,S/AS02A vaccine was safe, well tolerated, and immunogenic. Our results show development of an effective vaccine against malaria is feasible. [ABSTRACT FROM AUTHOR]
Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Efficacy of the RTS,S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: randomised controlled trial.
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  Data: Background Development of an effective malaria vaccine could greatly contribute to disease control. RTS,S/AS02A is a pre-erythrocytic vaccine candidate based on Plasmodium falciparum circumsporozoite surface antigen. We aimed to assess vaccine efficacy, immunogenicity, and safety in young African children. Methods We did a double-blind, phase IIb, randomised controlled trial in Mozambique in 2022 children aged 1--4 years. The study included two cohorts of children living in two separate areas which underwent different follow-up schemes. Participants were randomly allocated three doses of either RTS,S/AS02A candidate malaria vaccine or control vaccines. The primary endpoint, determined in cohort 1 (n=1605), was time to first clinical episode of P falciparum malaria (axillary temperature 37.5&#176;C and P falciparum asexual parasitaemia &gt;2500 per L) over a 6-month surveillance period. Efficacy for prevention of new infections was determined in cohort 2 (n=417). Analysis was per protocol. Findings 115 children in cohort 1 and 50 in cohort 2 did not receive all three doses and were excluded from the perprotocol analysis. Vaccine efficacy for the first clinical episodes was 29.9% (95% CI 11.0--44.8; p=0.004). At the end of the 6-month observation period, prevalence of P falciparum infection was 37% lower in the RTS,S/AS02A group compared with the control group (11.9% vs 18.9%; p=0.0003). Vaccine efficacy for severe malaria was 57.7% (95% CI 16.2--80.6; p=0.019). In cohort 2, vaccine efficacy for extending time to first infection was 45.0% (31.4--55.9; p&lt;0.0001). Interpretation The RTS,S/AS02A vaccine was safe, well tolerated, and immunogenic. Our results show development of an effective vaccine against malaria is feasible. [ABSTRACT FROM AUTHOR]
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  Data: &lt;i&gt;Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder&#39;s express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.&lt;/i&gt; (Copyright applies to all Abstracts.)
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