Article

First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children.

Selidji Todagbe Agnandji, Bertrand Lell, Solange Solmeheim Soulanoudjingar, José Francisco Fernandes, Béatrice Peggy Abossolo, Cornelia Conzelmann, Barbara Gaelle Nfono Ondo Methogo, Yannick Doucka, Arnaud Flamen, Benjamin Mordmüller, Saadou Issifou, Peter Gottfried Kremsner, Jahit Sacarlal, Pedro Aide, Miguel Lanaspa, John J Aponte, Arlindo Nhamuave, Diana Quelhas, Quique Bassat, Sofia Mandjate, Eusébio Macete, Pedro Alonso, Salim Abdulla, Nahya Salim, Omar Juma, Mwanajaa Shomari, Kafuruki Shubis, Francisca Machera, Ali Said Hamad, Rose Minja, Ali Mtoro, Alma Sykes, Saumu Ahmed, Alwisa Martin Urassa, Ali Mohammed Ali, Grace Mwangoka, Marcel Tanner, Halidou Tinto, Umberto D'Alessandro, Hermann Sorgho, Innocent Valea, Marc Christian Tahita, William Kaboré, Sayouba Ouédraogo, Yara Sandrine, Robert Tinga Guiguemdé, Jean Bosco Ouédraogo, Mary J Hamel, Simon Kariuki, Chris Odero, Martina Oneko, Kephas Otieno, Norbert Awino, Jackton Omoto, John Williamson, Vincent Muturi-Kioi, Kayla F Laserson, Laurence Slutsker, Walter Otieno, Lucas Otieno, Otsyula Nekoye, Stacey Gondi, Allan Otieno, Bernhards Ogutu, Ruth Wasuna, Victorine Owira, David Jones, Agnes Akoth Onyango, Patricia Njuguna, Roma Chilengi, Pauline Akoo, Christine Kerubo, Jesse Gitaka, Charity Maingi, Trudie Lang, Ally Olotu, Benjamin Tsofa, Philip Bejon, Norbert Peshu, Kevin Marsh, Seth Owusu-Agyei, Kwaku Poku Asante, Kingsley Osei-Kwakye, Owusu Boahen, Samuel Ayamba, Kingsley Kayan, Ruth Owusu-Ofori, David Dosoo, Isaac Asante, George Adjei, Daniel Chandramohan, Brian Greenwood, John Lusingu, Samwel Gesase, Anangisye Malabeja, Omari Abdul, Hassan Kilavo, Coline Mahende, Edwin Liheluka, Martha Lemnge, Thor Theander, Chris Drakeley, Daniel Ansong, Tsiri Agbenyega, Samuel Adjei, Harry Owusu Boateng, Theresa Rettig, John Bawa, Justice Sylverken, David Sambian, Alex Agyekum, Larko Owusu, Francis Martinson, Irving Hoffman, Tisungane Mvalo, Portia Kamthunzi, Ruthendo Nkomo, Albans Msika, Allan Jumbe, Nelecy Chome, Dalitso Nyakuipa, Joseph Chintedza, W Ripley Ballou, Myriam Bruls, Joe Cohen, Yolanda Guerra, Erik Jongert, Didier Lapierre, Amanda Leach, Marc Lievens, Opokua Ofori-Anyinam, Johan Vekemans, Terrell Carter, Didier Leboulleux, Christian Loucq, Afiya Radford, Barbara Savarese, David Schellenberg, Marla Sillman, Preeti Vansadia

Albert Schweitzer Hospital, Lambarene, Gabon.
New England Journal of Medicine (impact factor: 53.3). 11/2011; 365(20):1863-75. DOI:10.1056/NEJMoa1102287 pp.1863-75
Source: PubMed

ABSTRACT An ongoing phase 3 study of the efficacy, safety, and immunogenicity of candidate malaria vaccine RTS,S/AS01 is being conducted in seven African countries.
From March 2009 through January 2011, we enrolled 15,460 children in two age categories--6 to 12 weeks of age and 5 to 17 months of age--for vaccination with either RTS,S/AS01 or a non-malaria comparator vaccine. The primary end point of the analysis was vaccine efficacy against clinical malaria during the 12 months after vaccination in the first 6000 children 5 to 17 months of age at enrollment who received all three doses of vaccine according to protocol. After 250 children had an episode of severe malaria, we evaluated vaccine efficacy against severe malaria in both age categories.
In the 14 months after the first dose of vaccine, the incidence of first episodes of clinical malaria in the first 6000 children in the older age category was 0.32 episodes per person-year in the RTS,S/AS01 group and 0.55 episodes per person-year in the control group, for an efficacy of 50.4% (95% confidence interval [CI], 45.8 to 54.6) in the intention-to-treat population and 55.8% (97.5% CI, 50.6 to 60.4) in the per-protocol population. Vaccine efficacy against severe malaria was 45.1% (95% CI, 23.8 to 60.5) in the intention-to-treat population and 47.3% (95% CI, 22.4 to 64.2) in the per-protocol population. Vaccine efficacy against severe malaria in the combined age categories was 34.8% (95% CI, 16.2 to 49.2) in the per-protocol population during an average follow-up of 11 months. Serious adverse events occurred with a similar frequency in the two study groups. Among children in the older age category, the rate of generalized convulsive seizures after RTS,S/AS01 vaccination was 1.04 per 1000 doses (95% CI, 0.62 to 1.64).
The RTS,S/AS01 vaccine provided protection against both clinical and severe malaria in African children. (Funded by GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov number, NCT00866619 .).

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Keywords

11 months
 
12 months
 
14 months
 
17 months
 
average follow-up
 
clinical malaria
 
combined age categories
 
first dose
 
intention-to-treat population
 
non-malaria comparator vaccine
 
older age category
 
ongoing phase 3 study
 
PATH Malaria Vaccine Initiative
 
per-protocol population
 
primary end point
 
Serious adverse events
 
severe malaria
 
three doses
 
two study groups
 
Vaccine efficacy
 

Selidji Todagbe Agnandji