A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants.
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Hermann
Sorgho
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Innocent
Valea
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Biébo
Bihoun
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Issa
Guiraud
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Berenger
Kaboré
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Olivier
Sombié
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Robert Tinga
Guiguemdé
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Jean Bosco
Ouédraogo
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Mary J
Hamel
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Simon
Kariuki
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Martina
Oneko
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Chris
Odero
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Kephas
Otieno
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Norbert
Awino
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Meredith
McMorrow
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Vincent
Muturi-Kioi
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Kayla F
Laserson
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Laurence
Slutsker
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Walter
Otieno
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Lucas
Otieno
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Nekoye
Otsyula
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Stacey
Gondi
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Allan
Otieno
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Victorine
Owira
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Esther
Oguk
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George
Odongo
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Jon Ben
Woods
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Bernhards
Ogutu
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Patricia
Njuguna
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Roma
Chilengi
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Pauline
Akoo
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Christine
Kerubo
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Charity
Maingi
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Trudie
Lang
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Ally
Olotu
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Philip
Bejon
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Kevin
Marsh
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Gabriel
Mwambingu
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Seth
Owusu-Agyei
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Kwaku Poku
Asante
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Kingsley
Osei-Kwakye
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Owusu
Boahen
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David
Dosoo
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Isaac
Asante
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George
Adjei
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Evans
Kwara
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Daniel
Chandramohan
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Brian
Greenwood
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John
Lusingu
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Samwel
Gesase
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Anangisye
Malabeja
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Omari
Abdul
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Coline
Mahende
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Edwin
Liheluka
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Lincoln
Malle
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Martha
Lemnge
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Thor G
Theander
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Chris
Drakeley
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Daniel
Ansong
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Tsiri
Agbenyega
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Samuel
Adjei
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Harry Owusu
Boateng
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Theresa
Rettig
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John
Bawa
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Justice
Sylverken
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David
Sambian
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Anima
Sarfo
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Alex
Agyekum
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Francis
Martinson
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Irving
Hoffman
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Tisungane
Mvalo
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Portia
Kamthunzi
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Rutendo
Nkomo
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Tapiwa
Tembo
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Gerald
Tegha
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Mercy
Tsidya
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Jane
Kilembe
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Chimwemwe
Chawinga
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W Ripley
Ballou
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Joe
Cohen
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Yolanda
Guerra
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Erik
Jongert
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Didier
Lapierre
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Amanda
Leach
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Marc
Lievens
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Opokua
Ofori-Anyinam
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Aurélie
Olivier
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Johan
Vekemans
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Terrell
Carter
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David
Kaslow
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Didier
Leboulleux
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Christian
Loucq
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Afiya
Radford
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Barbara
Savarese
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David
Schellenberg
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Marla
Sillman
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Preeti
Vansadia
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(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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