Safety and Immunogenicity of an AMA1 Malaria Vaccine in Malian Children: Results of a Phase 1 Randomized Controlled Trial

• DOI: 10.1371/journal.pone.0009041
• Publication Date: 2010-02-03T18:28:02Z
• Authors: Mahamadou A. Thera; Ogobara K. Doumbo; Drissa Coulibaly; Matthew B. Laurens; Abdoulaye K. Kone; Ando B. Guindo; Karim Traore; Mady Sissoko; Dapa A. Diallo; Issa Diarra; Bourema Kouriba; Modibo Daou; Amagana Dolo; Mounirou Baby; Mahamadou S. Sissoko; Issaka Sagara; Amadou Niangaly; Idrissa Traore; Ally Olotu; Olivier Godeaux; Amanda Leach; Marie-Claude Dubois; W. Ripley Ballou; Joe Cohen; Darby Thompson; Tina Dube; Lorraine Soisson; Carter L. Diggs; Shannon L. Takala; Kirsten E. Lyke; Brent House; David E. Lanar; Sheetij Dutta; D. Gray Heppner; Christopher V. Plowe
• Keywords: Rabies vaccine

Background The objective was to evaluate the safety and immunogenicity of AMA1-based malaria vaccine FMP2.1/AS02A in children exposed seasonal falciparum malaria. Methodology/Principal Findings A Phase 1 double blind randomized controlled dose escalation trial conducted Bandiagara, Mali, West Africa, a rural town with intense transmission Plasmodium is recombinant protein (FMP2.1) based on apical membrane antigen (AMA1) from 3D7 clone P. falciparum, formulated Adjuvant System AS02A. comparator cell-culture rabies virus (RabAvert®). One hundred healthy Malian aged 1–6 years were recruited into 3 cohorts receive either 10 µg FMP2.1 0.1 mL AS02A, or 25 0.25 50 0.5 vaccine. Three doses given at 0, 2 months, followed for year. Solicited symptoms assessed 7 days unsolicited 30 after each vaccination. Serious adverse events throughout study. Transient local pain swelling common more frequent all dosage groups than group, but acceptable parents participants. Levels anti-AMA1 antibodies measured by ELISA increased significantly (at least 100-fold compared baseline) groups, remained high during year follow up. Conclusion/Significance had good profile, well-tolerated, induced sustained antibody levels malaria-exposed children. This being evaluated efficacy this site. Trial Registration ClinicalTrials.gov NCT00358332 [NCT00358332]