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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
A randomized and controlled Phase 1 study of the safety and immunogenicity of the AMA1-C1/Alhydrogel
®
+ CPG 7909 vaccine for Plasmodium falciparum malaria in semi-immune Malian adults
Vaccine, Volume 27, No. 52, Year 2009
Notification
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Description
A double blind, randomized and controlled Phase 1 clinical trial was conducted to assess the safety and immunogenicity in malaria-exposed adults of the Plasmodium falciparum blood stage vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1)/Alhydrogel® with and without the novel adjuvant CPG 7909. Participants were healthy adults 18-45 years old living in the village of Donéguébougou, Mali. A total of 24 participants received 2 doses one month apart of either 80 μg AMA1-C1/Alhydrogel® or 80 μg AMA1-C1/Alhydrogel® + 564 μg CPG 7909. The study started in October 2007 and completed follow up in May 2008. Both vaccines were well tolerated, with only mild local adverse events and no systemic adverse events judged related to vaccination. The difference in antibody responses were over 2-fold higher in the group receiving CPG 7909 for all time points after second vaccination and the differences are statistically significant (all p < 0.05). This is the first use of the novel adjuvant CPG 7909 in a malaria-exposed population. © 2009 Elsevier Ltd.
Authors & Co-Authors
Sagara, Issaka
Mali, Bamako
University of Bamako Faculty of Medicine, Pharmacy and Odonto-stomatology
Ellis, Ruth D.
United States, Bethesda
National Institute of Allergy and Infectious Diseases Niaid
Dicko, Alassane A.
Mali, Bamako
University of Bamako Faculty of Medicine, Pharmacy and Odonto-stomatology
Niambélé, Mohamed Balla
Mali, Bamako
University of Bamako Faculty of Medicine, Pharmacy and Odonto-stomatology
Kamate, Beh
Mali, Bamako
University of Bamako Faculty of Medicine, Pharmacy and Odonto-stomatology
Guindo, Ousmane
Mali, Bamako
University of Bamako Faculty of Medicine, Pharmacy and Odonto-stomatology
Sissoko, Mahamadou Soumana
Mali, Bamako
University of Bamako Faculty of Medicine, Pharmacy and Odonto-stomatology
Fay, Michael P.
United States, Bethesda
National Institute of Allergy and Infectious Diseases Niaid
Guindo, Merepen Agnes
Mali, Bamako
University of Bamako Faculty of Medicine, Pharmacy and Odonto-stomatology
Kante, Ousmane
Mali, Bamako
University of Bamako Faculty of Medicine, Pharmacy and Odonto-stomatology
Saye, Rénion
Mali, Bamako
University of Bamako Faculty of Medicine, Pharmacy and Odonto-stomatology
Miura, Kazutoyo
United States, Bethesda
National Institute of Allergy and Infectious Diseases Niaid
Long, Carole A.
United States, Bethesda
National Institute of Allergy and Infectious Diseases Niaid
Mullen, Gregory E.D.
United States, Bethesda
National Institute of Allergy and Infectious Diseases Niaid
Pierce, Mark A.
United States, Bethesda
National Institute of Allergy and Infectious Diseases Niaid
Martin, Laura B.
United States, Bethesda
National Institute of Allergy and Infectious Diseases Niaid
Rausch, Kelly M.
United States, Bethesda
National Institute of Allergy and Infectious Diseases Niaid
Dolo, Amagana I.
Mali, Bamako
University of Bamako Faculty of Medicine, Pharmacy and Odonto-stomatology
Diallo, Dapa Aly
Mali, Bamako
University of Bamako Faculty of Medicine, Pharmacy and Odonto-stomatology
Miller, Louis H.
United States, Bethesda
National Institute of Allergy and Infectious Diseases Niaid
Doumbo, Ogobara K.
Mali, Bamako
University of Bamako Faculty of Medicine, Pharmacy and Odonto-stomatology
Statistics
Citations: 92
Authors: 21
Affiliations: 2
Identifiers
Doi:
10.1016/j.vaccine.2009.10.087
ISSN:
0264410X
Research Areas
Disability
Infectious Diseases
Study Design
Cross Sectional Study
Study Locations
Mali