45 infants in Africa (Burkina Faso) were vaccinated for Malaria and Hep-B; 2008 Study is recruiting Safety and Immunogenicity of the Malaria Vaccine Candidate MSP3 Long Synthetic Peptide in 12–24 Months-Old Burkinabe Children Funding: This clinical trial (clinicaltrials.gov NCT00452088) was sponsored by the African Malaria Network Trust and funded by the EC AIDCO. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The burden of malaria remains high in sub-Saharan countries despite the extensive deployment of existing control tools, such as insecticide-treated materials, intermittent preventive treatment, and artemisinin-based combination therapy (ACT) [1]. The development of an effective malaria vaccine could greatly contribute to disease control. In recent years, the effort to develop an effective malaria vaccine has resulted in a number of malaria vaccine candidates reaching the stage of testing in malaria-exposed populations. The study was a double-blind, randomized, controlled, dose escalation phase Ib trial (clinicaltrials.gov NCT00452088) designed to assess the safety, reactogenicity and immunogenicity of three injections of either 15 µg or 30 µg of MSP3-LSP adsorbed on aluminum hydroxide in children 12 to 24 months of age. Trial participants were recruited among healthy children living in four villages within Saponé health district. The study duration was one year for enrolled participants. This study was designed to evaluate the reactogenicity, safety and immunogenicity of P. falciparum Merozoite Surface Protein-3 Long Synthetic Peptide (MSP 3-LSP) with aluminum hydroxide as adjuvant in 12 to 24 month old children in Burkina Faso. The study provides evidence of the safety and tolerability of MSP3-LSP when given to young children with prior exposure to malaria in Burkina Faso. We opted for a dose escalating design because this was the first time this vaccine had been given to young children. The study vaccines: The MSP3-LSP vaccine is a long synthetic peptide, produced by SYNPROSIS in France, and containing the amino-acid sequence 154–249 of the P.falciparum merozoite surface protein-3. It is 98.5% pure, very stable over time and underwent a full quality control process, including an assessment of potency, antigen content and conformity to specifications by HPLC and mass-spectrometry, one month before being employed for vaccination. ENGERIX-B® [Hepatitis B Vaccine (Recombinant)] vaccine is manufactured by GlaxoSmithKline Biologicals. It contains purified viral surface antigen expressed in Saccharomyces cerevisiae and contains no more than 5% yeast protein. ENGERIX-B® was supplied as a sterile suspension, using the same adjuvant as MSP3-LSP (aluminum hydroxide), in a pre-filled syringe for intramuscular administration. Each child in the comparator group received 0.5 mL of ENGERIX-B® containing 10 µg of the hepatitis B surface antigen at each vaccination. Given our results, we believe that the 30 µg dose of MSP3 should be evaluated in larger trials to investigate both immunogenicity and in vivo biological activity as demonstrated by, for example, protection against malaria episodes or reduced severity of malarial disease. plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0007549 synprosis/synprosis/index.php/about-synprosis investinprovence/uploads/news/SynprosisUK.pdf
Posted on: Sun, 21 Jul 2013 10:23:18 +0000
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