Phase 1 Trial of the Plasmodium falciparum Blood Stage Vaccine MSP142-C1/Alhydrogel with and without CPG 7909 in Malaria Naïve Adults

Background Merozoite surface protein 142 (MSP142) is a leading blood stage malaria vaccine candidate. In order to induce immune responses that cover the major antigenic polymorphisms, FVO and 3D7 recombinant proteins of MSP142 were mixed (MSP142-C1). To improve the level of antibody response, MSP142...

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Published in:PloS one 2010-01, Vol.5 (1), p.e8787
Main Authors: Ellis, Ruth D., Martin, Laura B., Shaffer, Donna, Long, Carole A., Miura, Kazutoyo, Fay, Michael P., Narum, David L., Zhu, Daming, Mullen, Gregory E. D., Mahanty, Siddhartha, Miller, Louis H., Durbin, Anna P.
Format: Article
Language:English
Subjects:
Adults
Antibody response
Antigens
Blood
Climate change
CpG islands
Erythema
Immune response
Immunization
Immunogenicity
Immunology/Immune Response
Infectious Diseases
Infectious Diseases/Tropical and Travel-Associated Diseases
Inhibition
Laboratories
Malaria
Mortality
Parasites
Parasitic diseases
Plasmodium falciparum
Proteins
Public health
Quality
Review boards
Safety
Slopes
Vaccination
Vaccines
Vector-borne diseases
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Summary:Background Merozoite surface protein 142 (MSP142) is a leading blood stage malaria vaccine candidate. In order to induce immune responses that cover the major antigenic polymorphisms, FVO and 3D7 recombinant proteins of MSP142 were mixed (MSP142-C1). To improve the level of antibody response, MSP142-C1 was formulated with Alhydrogel plus the novel adjuvant CPG 7909. Methods A Phase 1 clinical trial was conducted in healthy malaria-naïve adults at the Center for Immunization Research in Washington, D.C., to evaluate the safety and immunogenicity of MSP142-C1/Alhydrogel +/− CPG 7909. Sixty volunteers were enrolled in dose escalating cohorts and randomized to receive three vaccinations of either 40 or 160 µg protein adsorbed to Alhydrogel +/− 560 µg CPG 7909 at 0, 1 and 2 months. Results Vaccinations were well tolerated, with only one related adverse event graded as severe (Grade 3 injection site erythema) and all other vaccine related adverse events graded as either mild or moderate. Local adverse events were more frequent and severe in the groups receiving CPG. The addition of CPG enhanced anti-MSP142 antibody responses following vaccination by up to 49-fold two weeks after second immunization and 8-fold two weeks after the third immunization when compared to MSP142-C1/Alhydrogel alone (p
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0008787