A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants.
;
Hermann Sorgho;
Innocent Valea;
Biébo Bihoun;
Issa Guiraud;
Berenger Kaboré;
Olivier Sombié;
Robert Tinga Guiguemdé;
Jean Bosco Ouédraogo;
Mary J Hamel;
Simon Kariuki;
Martina Oneko;
Chris Odero;
Kephas Otieno;
Norbert Awino;
Meredith McMorrow;
Vincent Muturi-Kioi;
Kayla F Laserson;
Laurence Slutsker;
Walter Otieno;
Lucas Otieno;
Nekoye Otsyula;
Stacey Gondi;
Allan Otieno;
Victorine Owira;
Esther Oguk;
George Odongo;
Jon Ben Woods;
Bernhards Ogutu;
Patricia Njuguna;
Roma Chilengi;
Pauline Akoo;
Christine Kerubo;
Charity Maingi;
Trudie Lang;
Ally Olotu;
Philip Bejon;
Kevin Marsh;
Gabriel Mwambingu;
Seth Owusu-Agyei;
Kwaku Poku Asante;
Kingsley Osei-Kwakye;
Owusu Boahen;
David Dosoo ;
Isaac Asante;
George Adjei;
Evans Kwara;
Daniel Chandramohan ;
Brian Greenwood ;
John Lusingu;
Samwel Gesase;
Anangisye Malabeja;
Omari Abdul;
Coline Mahende;
Edwin Liheluka;
Lincoln Malle;
Martha Lemnge;
Thor G Theander;
Chris Drakeley ;
Daniel Ansong;
Tsiri Agbenyega;
Samuel Adjei;
Harry Owusu Boateng;
Theresa Rettig;
John Bawa;
Justice Sylverken;
David Sambian;
Anima Sarfo;
Alex Agyekum;
Francis Martinson;
Irving Hoffman;
Tisungane Mvalo;
Portia Kamthunzi;
Rutendo Nkomo;
Tapiwa Tembo;
Gerald Tegha;
Mercy Tsidya;
Jane Kilembe;
Chimwemwe Chawinga;
W Ripley Ballou;
Joe Cohen;
Yolanda Guerra;
Erik Jongert;
Didier Lapierre;
Amanda Leach;
Marc Lievens;
Opokua Ofori-Anyinam;
Aurélie Olivier;
Johan Vekemans;
Terrell Carter;
David Kaslow;
Didier Leboulleux;
Christian Loucq;
Afiya Radford;
Barbara Savarese;
David Schellenberg ;
Marla Sillman;
Preeti Vansadia;
(2012)
A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants.
The New England journal of medicine, 367 (24).
pp. 2284-2295.
ISSN 0028-4793
DOI: 10.1056/NEJMoa1208394
BACKGROUND: The candidate malaria vaccine RTS,S/AS01 reduced episodes of both clinical and severe malaria in children 5 to 17 months of age by approximately 50% in an ongoing phase 3 trial. We studied infants 6 to 12 weeks of age recruited for the same trial. METHODS: We administered RTS,S/AS01 or a comparator vaccine to 6537 infants who were 6 to 12 weeks of age at the time of the first vaccination in conjunction with Expanded Program on Immunization (EPI) vaccines in a three-dose monthly schedule. Vaccine efficacy against the first or only episode of clinical malaria during the 12 months after vaccination, a coprimary end point, was analyzed with the use of Cox regression. Vaccine efficacy against all malaria episodes, vaccine efficacy against severe malaria, safety, and immunogenicity were also assessed. RESULTS: The incidence of the first or only episode of clinical malaria in the intention-to-treat population during the 14 months after the first dose of vaccine was 0.31 per person-year in the RTS,S/AS01 group and 0.40 per person-year in the control group, for a vaccine efficacy of 30.1% (95% confidence interval [CI], 23.6 to 36.1). Vaccine efficacy in the per-protocol population was 31.3% (97.5% CI, 23.6 to 38.3). Vaccine efficacy against severe malaria was 26.0% (95% CI, -7.4 to 48.6) in the intention-to-treat population and 36.6% (95% CI, 4.6 to 57.7) in the per-protocol population. Serious adverse events occurred with a similar frequency in the two study groups. One month after administration of the third dose of RTS,S/AS01, 99.7% of children were positive for anti-circumsporozoite antibodies, with a geometric mean titer of 209 EU per milliliter (95% CI, 197 to 222). CONCLUSIONS: The RTS,S/AS01 vaccine coadministered with EPI vaccines provided modest protection against both clinical and severe malaria in young infants. (Funded by GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov number, NCT00866619.).
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