Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel Adjuvant

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.

Conditions

• Hookworm Infection
• Hookworm Disease

Interventions

BIOLOGICAL

10 μg Na-GST-1/Alhydrogel

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

BIOLOGICAL

30 μg Na-GST-1/Alhydrogel

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

BIOLOGICAL

100 μg Na-GST-1/Alhydrogel

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

BIOLOGICAL

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

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

BIOLOGICAL

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

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

BIOLOGICAL

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

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

BIOLOGICAL

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

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

Sponsors & Collaborators

• Children's National Research Institute

  collaborator OTHER

• George Washington University

  collaborator OTHER

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• David Diemert, MD · Albert B. Sabin Vaccine Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2015-01-31

Completion

2015-06-30

Countries

• United States

Study Locations