A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali
- Sagara, Issaka
- Dicko, Alassane
- Ellis, Ruth D.
- Fay, Michael P.
- Diawara, Sory I.
- Assadou, Mahamadoun H.
- Sissoko, Mahamadou S.
- Kone, Mamady
- Diallo, Abdoulbaki I.
- Saye, Renion
- Guindo, Merepen A.
- Kante, Ousmane
- Niambele, Mohamed B.
- Miura, Kazutoyo
- Mullen, Gregory E. D.
- Pierce, Mark
- Martin, Laura B.
- Dolo, Amagana
- Diallo, Dapa A.
- Doumbo, Ogobara K.
- Miller, Louis H.
- Saul, Allan
Publication date
May 2009
DOIAbstract
A double blind, randomized, controlled Phase 2 clinical trial was conducted to assess the safety, immunogenicity, and biologic impact of the vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1), adjuvanted with Alhydrogel (R) Participants were healthy children 2-3 years old living in or near the village of Bancoumana. Mali. A total of 300 children received either the study vaccine or the comparator. No impact of vaccination was seen on the primary endpoint, the frequency of parasitemia measured as episodes >3000/mu L/day at risk. There was a negative impact of vaccination on the hemoglobin level during clinical malaria, and mean incidence of hemoglobi
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