NCT03373214

Na-GST-1/Alhydrogel With or Without CpG 10104 in Gabonese Adults

Randomized, Controlled, Phase 1 Study to Assess Safety and Immunogenicity of Na-GST-1/Alhydrogel®, With or Without a CPG ODN Adjuvant, in Gabonese Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Na-GST-1 is a protein expressed during the adult stage of the Necator americanus hookworm life cycle that is thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination with recombinant Na-GST-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of administering Na-GST-1 with or without the CpG 10104 immunostimulant 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 aged 18 to 50 years living in the area of Lambaréné, Gabon. Participants will receive three doses of the assigned vaccine(s) delivered intramuscularly (deltoid) on approximately Days 0, 56, and 112. Safety will be measured from the time of each study vaccination (Day 0) through 14 days after each study vaccination by the occurrence of solicited injection site and systemic reactogenicity events. Unsolicited non-serious adverse events (AEs) will be collected from the time of the first study vaccination through approximately 1 month after each study vaccination. New-onset chronic medical conditions and Serious Adverse Events (SAEs) will be collected from the time of the first study vaccination through approximately 9 months after the final study vaccination (final visit). Clinical laboratory evaluations for safety will be performed on venous blood collected approximately 14 days after each vaccination. Immunogenicity testing will include IgG antibody responses to each vaccine antigen, by a qualified indirect enzyme-linked immunosorbent assay (ELISA), on serum or plasma obtained prior to each study vaccination and at time points after each vaccination; the functional activity of vaccine-induced antibodies will be assessed by in vitro enzyme neutralization assays. Recruitment and enrollment into the study will occur on an ongoing basis, with each group being recruited and vaccinated in sequence. 24 subjects will be enrolled into 2 groups: * Group 1 (n=12): * 8 subjects will receive 30 µg Na-GST-1 plus 500 µg CPG 10104 delivered by IM injection in the deltoid muscle * 4 subjects will receive 100 µg Na-GST-1 delivered by IM injection in the deltoid muscle * Group 2 (n=12): * 8 subjects will receive 100 µg Na-GST-1 plus 500 µg CPG 10104 delivered by IM injection in the deltoid muscle * 4 subjects will receive 100 µg Na-GST-1 delivered by IM injection in the deltoid muscle

Conditions

• Hookworm Infection
• Hookworm Disease

Interventions

Type	Name	Description
BIOLOGICAL	Na-GST-1	Na-GST-1/Alhydrogel®
BIOLOGICAL	CPG 10104	CPG 10104

Timeline

• Start date: 2018-02-01
• Primary completion: 2019-02-28
• Completion: 2019-03-30
• First posted: 2017-12-14
• Last updated: 2021-01-13

Locations

1 site across 1 country: Gabon

Regulatory

• FDA-regulated drug study