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Phase 1 Trial of Na-ASP-2 Hookworm Vaccine in Previously Infected Brazilian Adults

NCT00473967 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2012-07-09

No results posted yet for this study

Summary

Na-ASP-2 is a protein expressed during the larval stage of the N. americanus hookworm life cycle. Vaccination with recombinant ASP-2 has protected dogs and hamsters from infection in challenge studies. In a clinical study in hookworm-uninfected adults in the USA, Na-ASP-2 Hookworm Vaccine was safe and immunogenic. This study will evaluate its safety and immunogenicity in individuals living in an area of endemic hookworm infection.

Conditions

  • Hookworm Infection

Interventions

BIOLOGICAL

Na-ASP-2 Hookworm Vaccine

Injections of one of three different dose concentrations of the Na-ASP-2 vaccine (10, 50, or 100 mcg) vs. the hepatitis B vaccine, delivered at 0, 2, and 4 months by intramuscular injection.

Sponsors & Collaborators

  • Oswaldo Cruz Foundation

    collaborator OTHER

  • George Washington University

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Albert B. Sabin Vaccine Institute

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-03-31
Completion
2009-03-31

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 NCT00473967 on ClinicalTrials.gov