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rdf:type |
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lifeskim:mentions |
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pubmed:issue |
10
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pubmed:dateCreated |
2009-10-27
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pubmed:databankReference |
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pubmed:abstractText |
The malaria vaccine candidate antigen RTS,S includes parts of the pre-erythrocytic stage circumsporozoite protein fused to the Hepatitis B surface antigen. Two Adjuvant Systems are in development for this vaccine, an oil-in water emulsion--based formulation (AS02) and a formulation based on liposomes (AS01). METHODS & PRINCIPAL FINDINGS: In this Phase II, double-blind study (NCT00307021), 180 healthy Gabonese children aged 18 months to 4 years were randomized to receive either RTS,S/AS01(E) or RTS,S/AS02(D), on a 0-1-2 month vaccination schedule. The children were followed-up daily for six days after each vaccination and monthly for 14 months. Blood samples were collected at 4 time-points. Both vaccines were well tolerated. Safety parameters were distributed similarly between the two groups. Both vaccines elicited a strong specific immune response after Doses 2 and 3 with a ratio of anti-CS GMT titers (AS02(D)/AS01(E)) of 0.88 (95% CI: 0.68-1.15) post-Dose 3. After Doses 2 and 3 of experimental vaccines, anti-CS and anti-HBs antibody GMTs were higher in children who had been previously vaccinated with at least one dose of hepatitis B vaccine compared to those not previously vaccinated.
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pubmed:commentsCorrections |
http://linkedlifedata.com/resource/pubmed/commentcorrection/19859560-10674660,
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pubmed:language |
eng
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pubmed:journal |
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pubmed:citationSubset |
IM
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pubmed:chemical |
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pubmed:status |
MEDLINE
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pubmed:issn |
1932-6203
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pubmed:author |
pubmed-author:AgnandjiSelidjiS,
pubmed-author:BallouW RipleyWR,
pubmed-author:CarterTerrellT,
pubmed-author:CohenJoeJ,
pubmed-author:DemoitieMarie-AngeMA,
pubmed-author:DuboisMarie-ClaudeMC,
pubmed-author:HaertleSonjaS,
pubmed-author:IssifouSaadouS,
pubmed-author:KremsnerPeter GPG,
pubmed-author:LeachAmandaA,
pubmed-author:LellBertrandB,
pubmed-author:LievensMarcM,
pubmed-author:OyakhiromenSunnyS,
pubmed-author:VekemansJohanJ,
pubmed-author:VillafanaTonyaT,
pubmed-author:von GlasenappIsabelleI
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pubmed:issnType |
Electronic
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pubmed:volume |
4
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
e7611
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pubmed:dateRevised |
2010-9-27
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pubmed:meshHeading |
pubmed-meshheading:19859560-Antibodies, Protozoan,
pubmed-meshheading:19859560-Child,
pubmed-meshheading:19859560-Child, Preschool,
pubmed-meshheading:19859560-Double-Blind Method,
pubmed-meshheading:19859560-Female,
pubmed-meshheading:19859560-Gabon,
pubmed-meshheading:19859560-Humans,
pubmed-meshheading:19859560-Infant,
pubmed-meshheading:19859560-Malaria, Falciparum,
pubmed-meshheading:19859560-Malaria Vaccines,
pubmed-meshheading:19859560-Male,
pubmed-meshheading:19859560-Plasmodium falciparum,
pubmed-meshheading:19859560-Treatment Outcome
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pubmed:year |
2009
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pubmed:articleTitle |
A randomized trial assessing the safety and immunogenicity of AS01 and AS02 adjuvanted RTS,S malaria vaccine candidates in children in Gabon.
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pubmed:affiliation |
Medical Research Unit, Albert Schweitzer Hospital, Lambaréné, Gabon.
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pubmed:publicationType |
Journal Article,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't,
Clinical Trial, Phase II
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