Phase 1 Trial of Na-ASP-2 Hookworm Vaccine in Previously Infected Brazilian Adults

Phase 1 Terminated 9 enrolled Albert B. Sabin Vaccine Institute George Washington University · collab London School of Hygiene and Tropical Medicine · collab Oswaldo Cruz Foundation · collab

RandomizedSingle-groupQuadruple-blindPrevention

Summary

Na-ASP-2 is a protein expressed during the larval stage of the N. americanus hookworm life cycle. Vaccination with recombinant ASP-2 has protected dogs and hamsters from infection in challenge studies. In a clinical study in hookworm-uninfected adults in the USA, Na-ASP-2 Hookworm Vaccine was safe and immunogenic. This study will evaluate its safety and immunogenicity in individuals living in an area of endemic hookworm infection.

Timeline

Start: 2007-05
Primary completion: 2008-03
Completion: 2009-03

Outcome

Outcome not reported

Stopped: “Occurrence of unacceptable adverse events.”

Publications

Results Diemert DJ, Pinto AG, Freire J, Jariwala A, Santiago H, Hamilton RG, Periago MV, Loukas A, Tribolet L, Mulvenna J, Correa-Oliveira R, Hotez PJ, Bethony JM. Generalized urticaria induced by the Na-ASP-2 hookworm vaccine: implications for the development of vaccines against helminths. J Allergy Clin Immunol. 2012 Jul;130(1):169-76.e6. doi: 10.1016/j.jaci.2012.04.027. Epub 2012 May 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Na-ASP-2	Vaccine	10 ug	Intramuscular
Subject	Na-ASP-2	Vaccine	50 ug	Intramuscular
Subject	Na-ASP-2	Vaccine	100 ug	Intramuscular