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A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali

2009; Elsevier BV; Volume: 27; Issue: 23 Linguagem: Inglês

10.1016/j.vaccine.2009.03.014

1873-2518

Issaka Sagara, Alassane Dicko, Ruth D. Ellis, Michael P. Fay, Sory Ibrahim Diawara, Mahamadoun H. Assadou, Mahamadou S. Sissoko, Mamady Kone, Abdoulbaki I. Diallo, Rénion Saye, Merepen A. Guindo, Ousmane Kante, Mohamed B. Niambele, Kazutoyo Miura, Gregory Mullen, Mark A. Pierce, Laura B. Martin, Amagana Dolo, Dapa A. Diallo, Ogobara K. Doumbo, Louis H. Miller, Allan Saul,

Hepatitis B Virus Studies

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®. 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/μL/day at risk. There was a negative impact of vaccination on the hemoglobin level during clinical malaria, and mean incidence of hemoglobin <8.5 g/dL, in the direction of lower hemoglobin in the children who received AMA1-C1, although these differences were not significant after correction for multiple tests. These differences were not seen in the second year of transmission.