Hookworm Infection Clinical Trial
Official title:
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
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.
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.
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