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Safety and immunogenicity of an AMA1 malaria vaccine in Malian children: Results of a phase 1 randomized controlled trial

Thera, Mahamadou A., Doumbo, Ogobara K., Coulibaly, Drissa, Laurens, Matthew B., Kone, Abdoulaye K., Guindo, Ando B., Traore, Karim, Sissoko, Mady, Diallo, Dapa A., Diarra, Issa, Kouriba, Bourema, Daou, Modibo, Dolo, Amagana, Baby, Mounirou, Sissoko, Mahamadou S., Sagara, Issaka, Niangaly, Amadou, Traore, Idrissa, Leach, Amanda J., Plowe, Christopher V. and et al. (2010). Safety and immunogenicity of an AMA1 malaria vaccine in Malian children: Results of a phase 1 randomized controlled trial. PLoS One,5(2):e9041-1-e9041-11.

Document type: Journal Article
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IRMA ID 75039815xPUB515
Title Safety and immunogenicity of an AMA1 malaria vaccine in Malian children: Results of a phase 1 randomized controlled trial
Author Thera, Mahamadou A.
Doumbo, Ogobara K.
Coulibaly, Drissa
Laurens, Matthew B.
Kone, Abdoulaye K.
Guindo, Ando B.
Traore, Karim
Sissoko, Mady
Diallo, Dapa A.
Diarra, Issa
Kouriba, Bourema
Daou, Modibo
Dolo, Amagana
Baby, Mounirou
Sissoko, Mahamadou S.
Sagara, Issaka
Niangaly, Amadou
Traore, Idrissa
Leach, Amanda J.
Plowe, Christopher V.
et al.
Journal Name PLoS One
Publication Date 2010
Volume Number 5
Issue Number 2
ISSN 1932-6203   (check CDU catalogue open catalogue search in new window)
Scopus ID 2-s2.0-77649084917
Start Page e9041-1
End Page e9041-11
Total Pages 11
Place of Publication United States
Publisher Public Library of Science
HERDC Category C1 - Journal Article (DIISR)
Abstract Background:
The objective was to evaluate the safety and immunogenicity of the AMA1-based malaria vaccine FMP2.1/AS02A in children exposed to seasonal falciparum malaria.

Methodology/Principal Findings:
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 (AMA1) from the 3D7 clone of P. falciparum, formulated in the Adjuvant System AS02A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert®). One hundred healthy Malian children aged 1–6 years were recruited into 3 cohorts and randomized to receive either 10 µg FMP2.1 in 0.1 mL AS02A, or 25 µg FMP2.1 in 0.25 mL AS02A, or 50 µg FMP2.1 50 µg in 0.5 mL AS02A, or rabies vaccine. Three doses of vaccine were given at 0, 1 and 2 months, and children were followed for 1 year. Solicited symptoms were assessed for 7 days and unsolicited symptoms for 30 days after each vaccination. Serious adverse events were assessed throughout the study. Transient local pain and swelling were common and more frequent in all malaria vaccine dosage groups than in the comparator group, but were acceptable to parents of participants. Levels of anti-AMA1 antibodies measured by ELISA increased significantly (at least 100-fold compared to baseline) in all 3 malaria vaccine groups, and remained high during the year of follow up.

The FMP2.1/AS02A vaccine had a good safety profile, was well-tolerated, and induced high and sustained antibody levels in malaria-exposed children. This malaria vaccine is being evaluated in a Phase 2 efficacy trial in children at this site.
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