NCT02126462

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

Randomized, Controlled, Phase 1 Study to Assess Safety and Immunogenicity of Co-administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 Adjuvanted With Alhydrogel® and Gluco-pyranosylphospho-lipid A in Gabonese Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

Double-blind, randomized, controlled dose-escalation Phase 1 clinical trial in hookworm exposed adults. Study site: Centre de Recherches Médicales de Lambaréné Number of participants: 32 in 2 cohorts of 16 Doses of Na-GST-1 to be tested: 30 and 100 μg Doses of Na-APR-1 to be tested: 30 and 100 μg Dose of GLA-AF: 5 μg per antigen Cohort 1: 30 μg of each of the two antigens (Na-GST-1/Alhydrogel® and Na-APR-1 (M74)/Alhydrogel®) or hepatitis B vaccine; Cohort 2: 100 μg of each of the two antigens (Na-GST- 1/Alhydrogel® and Na-APR-1 (M74) /Alhydrogel®) or hepatitis B vaccine. Randomization: Cohort 1: 30 μg Na-GST-1 + 30 μg Na-APR-1 (M74) (n = 12) versus Hepatitis B Vaccine/placebo (n = 4) Cohort 2: 100 μg Na-GST-1 + 100 μg Na-APR-1 (M74) (n = 12) versus Hepatitis B Vaccine + placebo (n = 4) The cohorts will be enrolled in a staggered fashion with safety data assessed prior to the Na-GST-1 and Na-APR-1 dose escalation from 30 to 100 µg. Pre-treatment: Albendazole (400 mg) at least 2 weeks prior to first vaccination Immunization schedule: Study days 0, 28 and 180 Route: Intramuscular in the deltoid muscle Study duration: approximately 20 months; each participant will be followed for a total of 12 months.

Conditions

• Hookworm Infection
• Hookworm Disease

Interventions

Type	Name	Description
BIOLOGICAL	Na-APR-1 (M74)/Alhydrogel®
BIOLOGICAL	Na-GST-1/Alhydrogel®
BIOLOGICAL	Hepatitis B vaccine	Hepatitis B vaccine co-administered with saline

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-02-01
• Completion: 2016-06-01
• First posted: 2014-04-30
• Last updated: 2017-05-31

Locations

1 site across 1 country: Gabon