Randomized, placebo-controlled, double-blind trial of the Na-ASP-2 Hookworm Vaccine in unexposed adults.

Randomized, placebo-controlled, double-blind trial of the Na-ASP-2 Hookworm Vaccine in unexposed adults. Research Abstract Details 

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Randomized, placebo-controlled, double-blind trial of the Na-ASP-2 Hookworm Vaccine in unexposed adults. Abstract Text:

Necator americanus Ancylostoma Secreted Protein-2 (Na-ASP-2) is a leading larval-stage hookworm vaccine candidate. Recombinant Na-ASP-2 was expressed in Pichia pastoris and formulated with Alhydrogel((R)). In a phase 1 trial, 36 healthy adults without history of hookworm infection were enrolled into 1 of 3 dose cohorts (n=12 per cohort) and randomized to receive intramuscular injections of either Na-ASP-2 or saline placebo. Nine participants in the first, second and third cohorts were assigned to receive 10, 50 and 100mug of Na-ASP-2, respectively, on study days 0, 56 and 112, while 3 participants in each cohort received placebo. The most frequent adverse events were mild-to-moderate injection site reactions; in 8 participants these were delayed and occurred up to 10 days after immunization. No serious adverse events occurred. Anti-Na-ASP-2 IgG endpoint titers as determined by ELISA increased from baseline in all vaccine groups and peaked 14 days after the third injection, with geometric mean titers of 1:7066, 1:7611 and 1:11,593 for the 10, 50 and 100mug doses, respectively, compared to <1:100 for saline controls (p<0.001). Antibody titers remained significantly elevated in all vaccine groups until the end of the study, approximately 8 months after the third vaccination. In vitro stimulation of PBMCs collected from participants with Na-ASP-2 resulted in robust proliferative responses in those who received vaccine, which increased with successive immunizations and remained high in the 50 and 100mug dose groups through the end of the study. This first trial of a human hookworm vaccine demonstrates that the Na-ASP-2 vaccine is well-tolerated and induces a prolonged immune response in adults not exposed to hookworm, justifying further testing of this vaccine in an endemic area.

Randomized, placebo-controlled, double-blind trial of the Na-ASP-2 Hookworm Vaccine in unexposed adults. Publishing Authors By Initials

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Randomized, placebo-controlled, double-blind trial of the Na-ASP-2 Hookworm Vaccine in unexposed adults. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Vaccine

VOLUME: 26

Page Numbers: 2408-17

Journal Abbreviation: Vaccine

ISSN: 0264-410X

DAY: 11

MONTH: 03

YEAR: 2008

Randomized, placebo-controlled, double-blind trial of the Na-ASP-2 Hookworm Vaccine in unexposed adults. Information

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LANGUAGE: eng

NlmUniqueID: 8406899

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AFFILIATION: Department of Microbiology, Immunology and Tropical Medicine, George Washington University Health Center, Washington, DC, United States.

Country: Netherlands

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MEDLINETA: Vaccine

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