drugset / Trial / NCT02126462

Safety and Immunogenicity of Co-Administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 in Gabonese Adults

NCT02126462

Phase 1 Completed 32 enrolled Baylor College of Medicine
RandomizedParallel-groupDouble-blindPrevention

Summary

Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator americanus hookworm life cycle that are thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination with recombinant GST-1 or APR-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Gabonese adults living in an area of endemic hookworm infection.

Timeline

Start
2014-11
Primary completion
2016-02
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hepatitis B vaccine Vaccine Intramuscular
Subject Na-APR-1 (M74) Vaccine 30 ug Intramuscular
Subject Na-APR-1 (M74) Vaccine 100 ug Intramuscular
Subject Na-GST-1 Protein / enzyme biologic 30 ug Intramuscular
Subject Na-GST-1 Protein / enzyme biologic 100 ug Intramuscular