NCT02476773

Study of Na-APR-1 (M74)/Alhydrogel® Co-administered With Na-GST-1/Alhydrogel in Brazilian Adults

Phase 1 Study of the Safety and Immunogenicity of Na-APR-1 (M74)/Alhydrogel® Co-administered With Na-GST-1/Alhydrogel® in Brazilian Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 45 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 wtih 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 Brazilian 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 living in the area of Americaninhas, Minas Gerais, Brazil. Subjects will receive three doses of the assigned vaccine delivered intramuscularly 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 third 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 an indirect enzyme-linked immunosorbent assay (ELISA) and also by ImmunoCAP, on serum obtained prior to each study vaccination and at time points after each vaccination; antibody affinity by Surface Plasmon Resonance; functional activity of vaccine-induced antibodies via in vitro enzyme neutralization assays; and, antigen-specific memory B cell responses. Recruitment and enrollment into the study will occur on an ongoing basis, with each group being recruited and vaccinated in sequence. 60 subjects will be enrolled into 6 groups of 10.

Conditions

• Hookworm Infection
• Hookworm Disease

Interventions

Type	Name	Description
BIOLOGICAL	Na-GST-1/Alhydrogel plus GLA-AF
BIOLOGICAL	Na-APR-1 (M74)/Alhydrogel
BIOLOGICAL	Na-APR-1 (M74)/Alhydrogel plus GLA-AF
BIOLOGICAL	Sterile Saline Placebo

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2015-06-19
• Last updated: 2019-12-03

Locations

1 site across 1 country: Brazil