title: 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.
abstract: 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 microg AMA1-C1/Alhydrogel or 80 microg AMA1-C1/Alhydrogel + 564 microg 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.
authors.affiliation: Malaria Research and Training Center, Faculty of Medicine Pharmacy and Dentistry, BP 1805, Bamako, University of Bamako, Mali. isagara@icermali.org
authors.forename: Issaka
authors.initials: I
authors.lastname: Sagara
authors.forename: Ruth D
authors.initials: RD
authors.lastname: Ellis
authors.forename: Alassane
authors.initials: A
authors.lastname: Dicko
authors.forename: Mohamed B
authors.initials: MB
authors.lastname: Niambele
authors.forename: Beh
authors.initials: B
authors.lastname: Kamate
authors.forename: Ousmane
authors.initials: O
authors.lastname: Guindo
authors.forename: Mahamadou S
authors.initials: MS
authors.lastname: Sissoko
authors.forename: Michael P
authors.initials: MP
authors.lastname: Fay
authors.forename: Merepen A
authors.initials: MA
authors.lastname: Guindo
authors.forename: Ousmane
authors.initials: O
authors.lastname: Kante
authors.forename: Renion
authors.initials: R
authors.lastname: Saye
authors.forename: Kazutoyo
authors.initials: K
authors.lastname: Miura
authors.forename: Carole
authors.initials: C
authors.lastname: Long
authors.forename: Gregory E D
authors.initials: GE
authors.lastname: Mullen
authors.forename: Mark
authors.initials: M
authors.lastname: Pierce
authors.forename: Laura B
authors.initials: LB
authors.lastname: Martin
authors.forename: Kelly
authors.initials: K
authors.lastname: Rausch
authors.forename: Amagana
authors.initials: A
authors.lastname: Dolo
authors.forename: Dapa A
authors.initials: DA
authors.lastname: Diallo
authors.forename: Louis H
authors.initials: LH
authors.lastname: Miller
authors.forename: Ogobara K
authors.initials: OK
authors.lastname: Doumbo
mesh_terms: D000276:Adjuvants, Immunologic / Q000494:pharmacology*; D000328:Adult; D000536:Aluminum Hydroxide / Q000276:immunology / Q000494:pharmacology; D000913:Antibodies, Protozoan / Q000097:blood; D000953:Antigens, Protozoan / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017780:Malaria Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D016778:Malaria, Falciparum / Q000276:immunology / Q000517:prevention & control*; D008297:Male; D008302:Mali; D008565:Membrane Proteins / Q000276:immunology*; D009838:Oligodeoxyribonucleotides / Q000276:immunology / Q000494:pharmacology; D010963:Plasmodium falciparum / Q000276:immunology; D015800:Protozoan Proteins / Q000276:immunology*; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000913:Antibodies, Protozoan; D000953:Antigens, Protozoan; D017780:Malaria Vaccines; D008565:Membrane Proteins; D009838:Oligodeoxyribonucleotides; C483020:ProMune; D015800:Protozoan Proteins; C090077:apical membrane antigen I, Plasmodium; D000536:Aluminum Hydroxide