A randomized and controlled Phase 1 study of the safety and immunogenicity of the AMA1-C1/Alhydrogel®+CPG 7909 vaccine forPlasmodium falciparummalaria in semi-immune Malian adults

A double blind, randomized and controlled Phase 1 clinical trial was conducted to assess the safety and immunogenicity in malaria-exposed adults of thePlasmodium falciparumblood stage vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1)/Alhydrogel®with and without the novel adjuvant C...

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Bibliographic Details
Published in:Vaccine 2009-12, Vol.27 (52), p.7292
Main Authors: Sagara, Issaka, Ellis, Ruth D, Dicko, Alassane, Niambele, Mohamed B, Kamate, Beh, Guindo, Ousmane, Sissoko, Mahamadou S, Fay, Michael P, Guindo, Merepen A, Kante, Ousmane, Saye, Renion, Miura, Kazutoyo, Long, Carole, Mullen, Gregory ED, Pierce, Mark, Martin, Laura B, Rausch, Kelly, Dolo, Amagana, Diallo, Dapa A, Miller, Louis H, Doumbo, Ogobara K
Format: Article
Language:English
Subjects:
Aluminum
Antigens
Clinical trials
Immunization
Infectious diseases
Laboratories
Malaria
Parasites
Proteins
Studies
Vaccines
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Summary:A double blind, randomized and controlled Phase 1 clinical trial was conducted to assess the safety and immunogenicity in malaria-exposed adults of thePlasmodium falciparumblood 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 80μg AMA1-C1/Alhydrogel®or 80μg AMA1-C1/Alhydrogel®+564μg 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 (allp
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2009.10.087