Details

Autor(en) / Beteiligte

• Thera, Mahamadou A
• Doumbo, Ogobara K
• Coulibaly, Drissa
• Diallo, Dapa A
• Kone, Abdoulaye K
• Guindo, Ando B
• Traore, Karim
• Dicko, Alassane
• Sagara, Issaka
• Sissoko, Mahamadou S
• Baby, Mounirou
• Sissoko, Mady
• Diarra, Issa
• Niangaly, Amadou
• Dolo, Amagana
• Daou, Modibo
• Diawara, Sory I
• Heppner, D Gray
• Stewart, V Ann
• Angov, Evelina
• Bergmann-Leitner, Elke S
• Lanar, David E
• Dutta, Sheetij
• Soisson, Lorraine
• Diggs, Carter L
• Leach, Amanda
• Owusu, Alex
• Dubois, Marie-Claude
• Cohen, Joe
• Nixon, Jason N
• Gregson, Aric
• Takala, Shannon L
• Lyke, Kirsten E
• Plowe, Christopher V
• Sutherland, Colin

Titel

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

Ist Teil von

• PloS one, 2008-01, Vol.3 (1), p.e1465

Ort / Verlag

United States: Public Library of Science

Erscheinungsjahr

2008

Quelle

MEDLINE

Beschreibungen/Notizen

• 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 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 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.