CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
10 μg Na-GST-1/Alhydrogel +6 morebiological
Likely dose
10 μg Na-GST-1/Alhydrogelfrom 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/NCT01385189
NCT01385189Phase 1Completed
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Phase I Study of the Safety and Immunogenicity of Na-GST-1/Alhydrogel® With Different Doses of the Novel Immunostimulant GLA-AF in Healthy Adults

Baylor College of Medicine·interventional·Posted Jun 30, 2011·Updated Jan 6, 2025

In Brief

A Phase 1 clinical trial evaluating 10 μg Na-GST-1/Alhydrogel, 30 μg Na-GST-1/Alhydrogel, and 5 other interventions for Hookworm Infection and Hookworm Disease. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This study is designed to evaluate the safety, reactogenicity, and immunogenicity of Na-GST-1 adsorbed to Alhydrogel® with or without two different dose concentrations of a novel adjuvant, GLA-AF (1 µg or 5 μg) among healthy adult volunteers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHookworm Infection, Hookworm Disease
CountriesUnited States
CollaboratorsChildren's National Research Institute, George Washington University

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 30, 2011
Enrollment StartMay 1, 2012
Primary CompletionJan 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 15.0 years ago

Interventions

10 μg Na-GST-1/Alhydrogelbiological

3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals

30 μg Na-GST-1/Alhydrogelbiological

3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals

100 μg Na-GST-1/Alhydrogelbiological

3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals

10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)biological

3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals

30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)biological

3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals

30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)biological

3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals

100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)biological

3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals