Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial.

Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial.

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The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/AS02A in adults exposed to seasonal malaria.A phase 1 double blind randomized controlled dose escalation trial was conducted in Bandiagara, Mali, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria.The malaria vaccine FMP2.

1/AS02A is a recombinant protein (FMP2.1) based on apical membrane antigen-1 (AMA-1) from the 3D7 clone of P.falciparum, adjuvanted with AS02A.The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert).

Sixty healthy, malaria-experienced adults aged 18-55 y were recruited into 2 cohorts and randomized to receive either a half dose or full Supplements dose of the malaria vaccine (FMP2.1 25 microg/AS02A 0.25 mL or FMP2.1 50 microg/AS02A 0.

5 mL) or rabies vaccine given in 3 doses at 0, 1 and 2 mo, and were followed for 1 y.Solicited symptoms were assessed for 7 d and unsolicited symptoms for 30 d after each vaccination.Serious adverse events were assessed throughout the study.Titers of anti-AMA-1 antibodies were measured by ELISA and P.

falciparum growth inhibition assays were performed on sera collected at pre- and post-vaccination time points.Transient local pain and swelling were Chamomile Flower common and more frequent in both malaria vaccine dosage groups than in the comparator group.Anti-AMA-1 antibodies increased significantly in both malaria vaccine groups, peaking at nearly 5-fold and more than 6-fold higher than baseline in the half-dose and full-dose groups, respectively.The FMP2.

1/AS02A vaccine had a good safety profile, was well-tolerated, and was highly immunogenic in malaria-exposed adults.This malaria vaccine is being evaluated in Phase 1 and 2 trials in children at this site.