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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants
New England Journal of Medicine, Volume 367, No. 24, Year 2012
Notification
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Description
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 personyear 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.) Copyright © 2012 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
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
Methogo, Barbara Gaelle Nfono Ondo
Gabon, Lambarene
Unité de Recherche Médicale, Albert Schweitzer Hospital
Germany, Tubingen
Eberhard Karls Universität Tübingen
Kabwende, Anita Lumeka
Gabon, Lambarene
Unité de Recherche Médicale, Albert Schweitzer Hospital
Germany, Tubingen
Eberhard Karls Universität Tübingen
Adégnika, Ayôla Akim
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
Spain, Barcelona
Universitat de Barcelona
Aíde, Pedro
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Lanaspa, Miguel
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Aponte, John Jairo
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
MacHevo, Sónia
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Acácio, Sozinho
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Bulo, Helder
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Sigaúque, Betuel
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
MacEte, Eusébio V.
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Alonso, Pedro Luís
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Universitat de Barcelona
Abdulla, Salim Mohammed K.
Tanzania, Ifakara
Ifakara Health Institute
Switzerland, Allschwil
Swiss Tropical and Public Health Institute Swiss Tph
Salim, Nahya
Tanzania, Ifakara
Ifakara Health Institute
Switzerland, Allschwil
Swiss Tropical and Public Health Institute Swiss Tph
Minja, Rose
Tanzania, Ifakara
Ifakara Health Institute
Switzerland, Allschwil
Swiss Tropical and Public Health Institute Swiss Tph
Mpina, Maxmillian Gideon
Tanzania, Ifakara
Ifakara Health Institute
Switzerland, Allschwil
Swiss Tropical and Public Health Institute Swiss Tph
Ahmed, Saumu
Tanzania, Ifakara
Ifakara Health Institute
Switzerland, Allschwil
Swiss Tropical and Public Health Institute Swiss Tph
Ali, Ali Mohamed
Tanzania, Ifakara
Ifakara Health Institute
Switzerland, Allschwil
Swiss Tropical and Public Health Institute Swiss Tph
Mtoro, Ali Takadir
Tanzania, Ifakara
Ifakara Health Institute
Switzerland, Allschwil
Swiss Tropical and Public Health Institute Swiss Tph
Hamad, Ali Said
Tanzania, Ifakara
Ifakara Health Institute
Switzerland, Allschwil
Swiss Tropical and Public Health Institute Swiss Tph
Mutani, Paul
Tanzania, Ifakara
Ifakara Health Institute
Switzerland, Allschwil
Swiss Tropical and Public Health Institute Swiss Tph
Tanner, Marcel
Tanzania, Ifakara
Ifakara Health Institute
Switzerland, Allschwil
Swiss Tropical and Public Health Institute Swiss Tph
Tinto, Halidou
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
D'Alessandro, Umberto
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Sorgho, Hermann
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Valea, Innocent
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Bihoun, Biébo
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Guiraud, Issa
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Kaboré, Bérenger Y.L.
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Sombié, Olivier Ouahamin
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Guiguemdé, Tinga Robert
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Ouedraogo, Jean Bosco
Burkina Faso, Bobo-dioulasso 01
Institut de Recherche en Sciences de la Santé
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Hamel, Mary J.
Kenya, Liverpool
Kemri/cdc Research and Public Health Collaboration
Kariuki, Simon K.
Kenya, Liverpool
Kemri/cdc Research and Public Health Collaboration
Oneko, Martina
Kenya, Liverpool
Kemri/cdc Research and Public Health Collaboration
Odero, Chris O.
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
McMorrow, Meredith Lynn
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
Otsyula, Nekoye N.
Kenya
Kemri-walter Reed Project
Gondi, Stacey
Kenya
Kemri-walter Reed Project
Otieno, Allan James
Kenya
Kemri-walter Reed Project
Owira, Victorine
Kenya
Kemri-walter Reed Project
Oguk, Esther
Kenya
Kemri-walter Reed Project
Odongo, George S.
Kenya
Kemri-walter Reed Project
Ben Woods, Jon
Kenya
Kemri-walter Reed Project
Ogutu, Bernhards R.
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
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
Bejon, Philip A.
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Marsh, Kevin
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Mwambingu, Gabriel
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Owusu-Agyei, Seth
Ghana, Kintampo
Kintampo Health Research Center
United Kingdom, London
London School of Hygiene & Tropical Medicine
Asante, Kwaku Poku
Ghana, Kintampo
Kintampo Health Research Center
United Kingdom, London
London School of Hygiene & Tropical Medicine
Osei-Kwakye, Kingsley
Ghana, Kintampo
Kintampo Health Research Center
United Kingdom, London
London School of Hygiene & Tropical Medicine
Boahen, Owusu
Ghana, Kintampo
Kintampo Health Research Center
United Kingdom, London
London School of Hygiene & Tropical Medicine
Dosoo, David Kwame
Ghana, Kintampo
Kintampo Health Research Center
United Kingdom, London
London School of Hygiene & Tropical Medicine
Adjei, George
Ghana, Kintampo
Kintampo Health Research Center
United Kingdom, London
London School of Hygiene & Tropical Medicine
Kwara, Evans
Ghana, Kintampo
Kintampo Health Research Center
United Kingdom, London
London School of Hygiene & Tropical Medicine
Chandramohan, Daniel
Ghana, Kintampo
Kintampo Health Research Center
United Kingdom, London
London School of Hygiene & Tropical Medicine
Greenwood, Brian M.
Ghana, Kintampo
Kintampo Health Research Center
United Kingdom, London
London School of Hygiene & Tropical Medicine
Lusingu, John Peter Andrea
United Kingdom, London
London School of Hygiene & Tropical Medicine
Tanzania, Tanga
National Institute for Medical Research Tanga
Denmark, Copenhagen
Københavns Universitet
Gesase, Samwel
United Kingdom, London
London School of Hygiene & Tropical Medicine
Tanzania, Tanga
National Institute for Medical Research Tanga
Denmark, Copenhagen
Københavns Universitet
Malabeja, Anangisye I.
United Kingdom, London
London School of Hygiene & Tropical Medicine
Tanzania, Tanga
National Institute for Medical Research Tanga
Denmark, Copenhagen
Københavns Universitet
Abdul, Omari
United Kingdom, London
London School of Hygiene & Tropical Medicine
Tanzania, Tanga
National Institute for Medical Research Tanga
Denmark, Copenhagen
Københavns Universitet
Mahende, Coline
United Kingdom, London
London School of Hygiene & Tropical Medicine
Tanzania, Tanga
National Institute for Medical Research Tanga
Denmark, Copenhagen
Københavns Universitet
Liheluka, Edwin A.
United Kingdom, London
London School of Hygiene & Tropical Medicine
Tanzania, Tanga
National Institute for Medical Research Tanga
Denmark, Copenhagen
Københavns Universitet
Malle, Lincoln N.
United Kingdom, London
London School of Hygiene & Tropical Medicine
Tanzania, Tanga
National Institute for Medical Research Tanga
Denmark, Copenhagen
Københavns Universitet
Lemnge, Martha M.M.
United Kingdom, London
London School of Hygiene & Tropical Medicine
Tanzania, Tanga
National Institute for Medical Research Tanga
Denmark, Copenhagen
Københavns Universitet
G. Theander, Thor Grundtvig
United Kingdom, London
London School of Hygiene & Tropical Medicine
Tanzania, Tanga
National Institute for Medical Research Tanga
Denmark, Copenhagen
Københavns Universitet
Drakeley, Chris J.
United Kingdom, London
London School of Hygiene & Tropical Medicine
Tanzania, Tanga
National Institute for Medical Research Tanga
Denmark, Copenhagen
Københavns Universitet
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
Tembo, Tapiwa A.
Malawi, Lilongwe
Unc Project-malawi
Tegha, Gerald L.
Malawi, Lilongwe
Unc Project-malawi
Tsidya, Mercy
Malawi, Lilongwe
Unc Project-malawi
Chawinga, Chimwemwe
Malawi, Lilongwe
Unc Project-malawi
Ballou, William Ripley
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
Olivier, Aurélie C.
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Vekemans, Johan
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Carter, Terrell C.
Unknown Affiliation
Kaslow, David C.
Unknown Affiliation
Leboulleux, Didier
Unknown Affiliation
Loucq, Christian
Unknown Affiliation
Savarese, Barbara M.
Unknown Affiliation
Schellenberg, David M.
Unknown Affiliation
Sillman, Marla
Unknown Affiliation
Vansadia, Preeti
Unknown Affiliation
Mian-McCarthy, Sara
Unknown Affiliation
Statistics
Citations: 699
Authors: 125
Affiliations: 18
Identifiers
Doi:
10.1056/NEJMoa1208394
ISSN:
00284793
Research Areas
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial
Cross Sectional Study
Cohort Study