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Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With or Without Additional Adjuvant in Brazilian Adults

NCT01261130 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2017-05-31

No results posted yet for this study

Summary

This two part study will evaluate the safety and immunogenicity of two formulations of Na-GST-1, first in hookworm-naïve individuals using an open-label design, and then in adults living in an area of endemic hookworm infection using a randomized, double-blind design. The two formulations to be evaluated are Na-GST-1 adsorbed to an adjuvant, Alhydrogel®, and Na-GST-1 adsorbed to Alhydrogel® and administered with GLA-AF.

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

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

BIOLOGICAL

30 μg Na-GST-1/Alhydrogel/GLA-AF

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

BIOLOGICAL

100 μg Na-GST-1/Alhydrogel/GLA-AF

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

BIOLOGICAL

Butang® hepatitis B vaccine

3 doses Butang® hepatitis B vaccine administered at 56 day intervals

Sponsors & Collaborators

  • 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
2011-11-30
Primary Completion
2014-08-31
Completion
2014-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01261130 on ClinicalTrials.gov