Browsing by Author "Sall AH"

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    Phase 1 randomized controlled trial to evaluate the safety and immunogenicity of recombinant Pichia pastoris-expressed Plasmodium falciparum apical membrane antigen 1 (PfAMA1-FVO [25-545]) in healthy Malian adults in Bandiagara.
    (2016-Aug-30) Thera MA; Coulibaly D; Kone AK; Guindo AB; Traore K; Sall AH; Diarra I; Daou M; Traore IM; Tolo Y; Sissoko M; Niangaly A; Arama C; Baby M; Kouriba B; Sissoko MS; Sagara I; Toure OB; Dolo A; Diallo DA; Remarque E; Chilengi R; Noor R; Sesay S; Thomas A; Kocken CH; Faber BW; Imoukhuede EB; Leroy O; Doumbo OK; European Vaccine Initiative, European Vaccine Initiative, Im Neuenheimer Feld 307, 69120, Heidelberg, Germany.; Center for Infectious Diseases Research in Zambia (CIDRZ), P.O. Box 34681, Lusaka, 10101, Zambia.; African Malaria Network Trust (AMANET), P.O. Box 33207, Dar Es Salaam, Tanzania.; Biomedical Primate Research Center (BPRC), P.O. Box 3306, 2280 GH, Rijswijk, The Netherlands.; Medical Research Council, P.O. Box 273, Banjul, The Gambia.; Malaria Research and Training Centre, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, University of Sciences, Techniques and Technologies, Bamako, Mali. mthera@icermali.org.; Malaria Research and Training Centre, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, University of Sciences, Techniques and Technologies, Bamako, Mali.
    BACKGROUND: The safety and immunogenicity of PfAMA1, adjuvanted with Alhydrogel(®) was assessed in malaria-experienced Malian adults. The malaria vaccine, PfAMA1-FVO [25-545] is a recombinant protein Pichia pastoris-expressed AMA-1 from Plasmodium falciparum FVO clone adsorbed to Alhydrogel(®), the control vaccine was tetanus toxoid produced from formaldehyde detoxified and purified tetanus toxin. METHODS: A double blind randomized controlled phase 1 study enrolled and followed 40 healthy adults aged 18-55 years in Bandiagara, Mali, West Africa, a rural setting with intense seasonal transmission of P. falciparum malaria. Volunteers were randomized to receive either 50 µg of malaria vaccine or the control vaccine. Three doses of vaccine were given on Days 0, 28 and 56, and participants were followed for 1 year. Solicited symptoms were assessed for seven days and unsolicited symptoms for 28 days after each vaccination. Serious adverse events were assessed throughout the study. The titres of anti-AMA-1 antibodies were measured by ELISA and P. falciparum growth inhibition assays were performed. RESULTS: Commonest local solicited adverse events were the injection site pain and swelling more frequent in the PfAMA1 group. No vaccine related serious adverse events were reported. A significant 3.5-fold increase of anti-AMA-1 IgG antibodies was observed in malaria vaccine recipients four weeks after the third immunization compared to the control group. CONCLUSION: The PfAMA1 showed a good safety profile. Most adverse events reported were of mild to moderate intensity. In addition, the vaccine induced a significant though short-lived increase in the anti-AMA1 IgG titres. Registered on www.clinicaltrials.gov with the number NCT00431808.