| Literature DB >> 19428923 |
Issaka Sagara1, Alassane Dicko, Ruth D Ellis, Michael P Fay, Sory I Diawara, Mahamadoun H Assadou, Mahamadou S Sissoko, Mamady Kone, Abdoulbaki I Diallo, Renion Saye, Merepen A Guindo, Ousmane Kante, Mohamed B Niambele, Kazutoyo Miura, Gregory E D Mullen, Mark Pierce, Laura B Martin, Amagana Dolo, Dapa A Diallo, Ogobara K Doumbo, Louis H Miller, Allan Saul.
Abstract
A double blind, randomized, controlled Phase 2 clinical trial was conducted to assess the safety, immunogenicity, and biologic impact of the vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1), adjuvanted with Alhydrogel. Participants were healthy children 2-3 years old living in or near the village of Bancoumana, Mali. A total of 300 children received either the study vaccine or the comparator. No impact of vaccination was seen on the primary endpoint, the frequency of parasitemia measured as episodes >3000/microL/day at risk. There was a negative impact of vaccination on the hemoglobin level during clinical malaria, and mean incidence of hemoglobin <8.5 g/dL, in the direction of lower hemoglobin in the children who received AMA1-C1, although these differences were not significant after correction for multiple tests. These differences were not seen in the second year of transmission.Entities:
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Year: 2009 PMID： 19428923 PMCID： PMC2713037 DOI： 10.1016/j.vaccine.2009.03.014
Source DB: PubMed Journal: Vaccine ISSN： 0264-410X Impact factor: 3.641