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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children
New England Journal of Medicine, Volume 365, No. 20, Year 2011
Notification
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Description
BACKGROUND: 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. METHODS: 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. RESULTS: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). CONCLUSIONS: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.) Copyright © 2011 Massachusetts Medical Society.
Authors & Co-Authors
Agnandji, Sélidji Todagbe M.
Gabon, Lambarene
Unité de Recherche Médicale, Albert Schweitzer Hospital
Germany, Tubingen
Eberhard Karls Universität Tübingen
Lell, Bertrand
Gabon, Lambarene
Unité de Recherche Médicale, Albert Schweitzer Hospital
Germany, Tubingen
Eberhard Karls Universität Tübingen
Soulanoudjingar, Solange Solmeheim
Gabon, Lambarene
Unité de Recherche Médicale, Albert Schweitzer Hospital
Germany, Tubingen
Eberhard Karls Universität Tübingen
Fernandes, José Francisco
Gabon, Lambarene
Unité de Recherche Médicale, Albert Schweitzer Hospital
Germany, Tubingen
Eberhard Karls Universität Tübingen
Abossolo, Béatrice Peggy
Gabon, Lambarene
Unité de Recherche Médicale, Albert Schweitzer Hospital
Germany, Tubingen
Eberhard Karls Universität Tübingen
Conzelmann, Cornelia
Gabon, Lambarene
Unité de Recherche Médicale, Albert Schweitzer Hospital
Germany, Tubingen
Eberhard Karls Universität Tübingen
Methogo, Barbara Gaelle Nfono Ondo
Gabon, Lambarene
Unité de Recherche Médicale, Albert Schweitzer Hospital
Germany, Tubingen
Eberhard Karls Universität Tübingen
Doucka, Yannick
Gabon, Lambarene
Unité de Recherche Médicale, Albert Schweitzer Hospital
Germany, Tubingen
Eberhard Karls Universität Tübingen
Flamen, Arnaud
Gabon, Lambarene
Unité de Recherche Médicale, Albert Schweitzer Hospital
Germany, Tubingen
Eberhard Karls Universität Tübingen
Mordmüller, Benjamin G.
Gabon, Lambarene
Unité de Recherche Médicale, Albert Schweitzer Hospital
Germany, Tubingen
Eberhard Karls Universität Tübingen
Issifou, Saadou
Gabon, Lambarene
Unité de Recherche Médicale, Albert Schweitzer Hospital
Germany, Tubingen
Eberhard Karls Universität Tübingen
Kremsner, Peter G.
Gabon, Lambarene
Unité de Recherche Médicale, Albert Schweitzer Hospital
Germany, Tubingen
Eberhard Karls Universität Tübingen
Sacarlal, J.
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Aíde, Pedro
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Lanaspa, Miguel
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Aponte, John Jairo
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Nhamuave, Arlindo
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Quelhas, Diana
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Bassat, Quique
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Mandjate, Sofia
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
MacEte, Eusébio V.
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Alonso, Pedro Luís
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Abdulla, Salim Mohammed K.
Tanzania, Ifakara
Ifakara Health Institute
Salim, Nahya
Tanzania, Ifakara
Ifakara Health Institute
Juma, Omar Ali
Tanzania, Ifakara
Ifakara Health Institute
Shomari, Mwanajaa
Tanzania, Ifakara
Ifakara Health Institute
Kafuruki, Shubis
Tanzania, Ifakara
Ifakara Health Institute
Machera, Francisca
Tanzania, Ifakara
Ifakara Health Institute
Hamad, Ali Said
Tanzania, Ifakara
Ifakara Health Institute
Minja, Rose
Tanzania, Ifakara
Ifakara Health Institute
Mpina, Maxmillian Gideon
Tanzania, Ifakara
Ifakara Health Institute
Mtoro, Ali Takadir
Tanzania, Ifakara
Ifakara Health Institute
Sykes, Alma
Tanzania, Ifakara
Ifakara Health Institute
Ahmed, Saumu
Tanzania, Ifakara
Ifakara Health Institute
Urassa, Alwisa Martin
Tanzania, Ifakara
Ifakara Health Institute
Ali, Mohammed Ayub
Tanzania, Ifakara
Ifakara Health Institute
Mwangoka, Grace W.
Tanzania, Ifakara
Ifakara Health Institute
Tanner, Marcel
Tanzania, Ifakara
Ifakara Health Institute
Tinto, Halidou
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
D'Alessandro, Umberto
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Sorgho, Hermann
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Valea, Innocent
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Tahita, Marc Christian
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Kaboré, William Mf
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Ouédraogo, Sayouba
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Sandrine, Yara
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Guiguemdé, Tinga Robert
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Ouedraogo, Jean Bosco
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Hamel, Mary J.
Kenya, Liverpool
Kemri/cdc Research and Public Health Collaboration
Kariuki, Simon K.
Kenya, Liverpool
Kemri/cdc Research and Public Health Collaboration
Odero, Chris O.
Kenya, Liverpool
Kemri/cdc Research and Public Health Collaboration
Oneko, Martina
Kenya, Liverpool
Kemri/cdc Research and Public Health Collaboration
Otieno, Kephas O.
Kenya, Liverpool
Kemri/cdc Research and Public Health Collaboration
Awino, Norbert
Kenya, Liverpool
Kemri/cdc Research and Public Health Collaboration
Omoto, Jackton
Kenya, Liverpool
Kemri/cdc Research and Public Health Collaboration
Williamson, John Michael
Kenya, Liverpool
Kemri/cdc Research and Public Health Collaboration
Muturi-Kioi, Vincent
Kenya, Liverpool
Kemri/cdc Research and Public Health Collaboration
Laserson, Kayla F.
Kenya, Liverpool
Kemri/cdc Research and Public Health Collaboration
Slutsker, Laurence
Kenya, Liverpool
Kemri/cdc Research and Public Health Collaboration
Otieno, Walter None
Kenya
Kemri-walter Reed Project
Otieno, Lucas
Kenya
Kemri-walter Reed Project
Nekoye, Otsyula
Kenya
Kemri-walter Reed Project
Gondi, Stacey
Kenya
Kemri-walter Reed Project
Otieno, Allan James
Kenya
Kemri-walter Reed Project
Ogutu, Bernhards R.
Kenya
Kemri-walter Reed Project
Wasuna, Ruth
Kenya
Kemri-walter Reed Project
Owira, Victorine
Kenya
Kemri-walter Reed Project
Jones, David
Kenya
Kemri-walter Reed Project
Onyango, Agnes Akoth
Kenya
Kemri-walter Reed Project
Njuguna, Patricia W.
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Chilengi, Roma
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Akoo, Pauline
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Kerubo, Christine
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Gitaka, Jesse N.
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Maingi, Charity
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Lang, Trudie A.
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Olotu, Ally Ibrahim
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Tsofa, Benjamin K.
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Bejon, Philip A.
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Peshu, Norbert M.
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Marsh, Kevin
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Owusu-Agyei, Seth
Ghana, Kintampo
Kintampo Health Research Center
Asante, Kwaku Poku
Ghana, Kintampo
Kintampo Health Research Center
Osei-Kwakye, Kingsley
Ghana, Kintampo
Kintampo Health Research Center
Boahen, Owusu
Ghana, Kintampo
Kintampo Health Research Center
Ayamba, Samuel
Ghana, Kintampo
Kintampo Health Research Center
Kayan, Kingsley
Ghana, Kintampo
Kintampo Health Research Center
Owusu-Ofori, Ruth
Ghana, Kintampo
Kintampo Health Research Center
Dosoo, David Kwame
Ghana, Kintampo
Kintampo Health Research Center
Adjei, George
Ghana, Kintampo
Kintampo Health Research Center
Kwara, Evans
Ghana, Kintampo
Kintampo Health Research Center
Chandramohan, Daniel
Ghana, Kintampo
Kintampo Health Research Center
Greenwood, Brian M.
Ghana, Kintampo
Kintampo Health Research Center
Lusingu, John Peter Andrea
Tanzania, Tanga
National Institute for Medical Research Tanga
Gesase, Samwel
Tanzania, Tanga
National Institute for Medical Research Tanga
Malabeja, Anangisye I.
Tanzania, Tanga
National Institute for Medical Research Tanga
Abdul, Omari
Tanzania, Tanga
National Institute for Medical Research Tanga
Kilavo, Hassan
Tanzania, Tanga
National Institute for Medical Research Tanga
Mahende, Coline
Tanzania, Tanga
National Institute for Medical Research Tanga
Liheluka, Edwin A.
Tanzania, Tanga
National Institute for Medical Research Tanga
Lemnge, Martha M.M.
Tanzania, Tanga
National Institute for Medical Research Tanga
G. Theander, Thor Grundtvig
Tanzania, Tanga
National Institute for Medical Research Tanga
Drakeley, Chris J.
Tanzania, Tanga
National Institute for Medical Research Tanga
Ansong, Daniel Ayirebi
Ghana, Kumasi
Kwame Nkrumah University of Science & Technology
Agbenyega, Tsiri E.
Ghana, Kumasi
Kwame Nkrumah University of Science & Technology
Adjei, Samuel
Ghana, Kumasi
Kwame Nkrumah University of Science & Technology
Owusu-Boateng, Harry
Ghana, Kumasi
Kwame Nkrumah University of Science & Technology
Rettig, Theresa
Ghana, Kumasi
Kwame Nkrumah University of Science & Technology
Bawa, John Tanko
Ghana, Kumasi
Kwame Nkrumah University of Science & Technology
Sylverken, Justice
Ghana, Kumasi
Kwame Nkrumah University of Science & Technology
Sambian, David J.
Ghana, Kumasi
Kwame Nkrumah University of Science & Technology
Agyekum, Alex
Ghana, Kumasi
Kwame Nkrumah University of Science & Technology
Martinson, Francis E.A.
Malawi, Lilongwe
Unc Project-malawi
Hoffman, Irving F.
Malawi, Lilongwe
Unc Project-malawi
Mvalo, Tisungane
Malawi, Lilongwe
Unc Project-malawi
Kamthunzi, Portia
Malawi, Lilongwe
Unc Project-malawi
Msika, Albans
Malawi, Lilongwe
Unc Project-malawi
Jumbe, Allan N.
Malawi, Lilongwe
Unc Project-malawi
Chome, Nelecy
Malawi, Lilongwe
Unc Project-malawi
Nyakuipa, Dalitso
Malawi, Lilongwe
Unc Project-malawi
Ballou, William Ripley
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Bruls, Myriam
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Cohen, Joe D.
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Guerra, Yolanda
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Jongert, Erik
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Lapierre, Didier H.
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Leach, Amanda
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Lievens, Marc J.J.
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Ofori-Anyinam, Opokua
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Vekemans, Johan
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Carter, Terrell C.
United States, Washington
Path Malaria Vaccine Initiative
Leboulleux, Didier
United States, Washington
Path Malaria Vaccine Initiative
Loucq, Christian
United States, Washington
Path Malaria Vaccine Initiative
Savarese, Barbara M.
United States, Washington
Path Malaria Vaccine Initiative
Schellenberg, David M.
United States, Washington
Path Malaria Vaccine Initiative
Sillman, Marla
United States, Washington
Path Malaria Vaccine Initiative
Vansadia, Preeti
United States, Washington
Path Malaria Vaccine Initiative
Statistics
Citations: 687
Authors: 137
Affiliations: 14
Identifiers
Doi:
10.1056/NEJMoa1102287
ISSN:
00284793
Research Areas
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial
Cross Sectional Study
Cohort Study