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Study of Na-ASP-2 Human Hookworm Vaccine in Healthy Adults Without Evidence of Hookworm Infection

NCT00120081 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-05-31

No results posted yet for this study

Summary

The primary objective of this clinical trial is to determine the safety and tolerability of the Na-ASP-2 Hookworm Vaccine in healthy subjects following the administration of 3 intramuscular (IM) injections of the vaccine over 16 weeks using 3 different doses. The secondary objective is to make a preliminary evaluation of the immunogenicity of each of the 3 doses of the vaccine in healthy volunteers.

Conditions

  • Hookworm Infection

Interventions

BIOLOGICAL

Na-ASP-2/Alhydrogel Hookworm Vaccine

The recombinant hookworm protein Na-ASP-2 formulated on aluminum hydroxide adjuvant (Alhydrogel), in one of three dose concentrations, compared to a saline placebo control.

BIOLOGICAL

Saline placebo

Inactive saline placebo control

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Gary Simon, M.D., Ph.D · George Washington University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2006-09-30
Completion
2006-09-30

Countries

  • United States

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 NCT00120081 on ClinicalTrials.gov