CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
Na-GST-1/Alhydrogel +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02839161
NCT02839161Phase 1Completed

Randomized, Controlled, Phase 1 Study to Assess Safety and Immunogenicity of Co-administered Hookworm Vaccine Candidates Na-APR-1 (M74)/Alhydrogel® and Na-GST-1/ Alhydrogel® in Gabonese Children

Baylor College of Medicine·interventional·Posted Jul 20, 2016·Updated Jan 13, 2025

In Brief

A Phase 1 clinical trial evaluating Na-GST-1/Alhydrogel, Na-APR-1 (M74)/Alhydrogel, and 1 other intervention for Hookworm Disease and Hookworm Infection. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in hookworm-exposed children aged 6 to 10 years living in the area of Lambaréné, Gabon. Children will receive three doses of the Na-GST-1/Alhydrogel hookworm vaccine co-administered with the Na-APR-1 (M74)/Alhydrogel hookworm vaccine or the hepatitis B vaccine co-administered with sterile saline. All injections will be delivered intramuscularly (deltoid) on approximately Days 0, 56, and 112 or 180.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGabon
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 20, 2016
Enrollment StartJan 1, 2017
Primary CompletionDec 13, 2018
Study CompletionMar 28, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.0 years ago

Interventions

Na-GST-1/Alhydrogelbiological

Na-APR-1 (M74)/Alhydrogelbiological

Hepatitis B Vaccinebiological