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Study of Na-APR-1 (M74)/Alhydrogel® Co-administered With Na-GST-1/Alhydrogel in Brazilian Adults

NCT02476773 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-12-03

No results posted yet for this study

Summary

Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator americanus hookworm life cycle that are thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination wtih recombinant GST-1 or APR-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Brazilian adults living in an area of endemic hookworm infection.

Conditions

  • Hookworm Infection
  • Hookworm Disease

Interventions

BIOLOGICAL

Na-GST-1/Alhydrogel plus GLA-AF

BIOLOGICAL

Na-APR-1 (M74)/Alhydrogel

BIOLOGICAL

Na-APR-1 (M74)/Alhydrogel plus GLA-AF

BIOLOGICAL

Sterile Saline Placebo

Sponsors & Collaborators

Principal Investigators

  • David Diemert, MD · George Washington University

  • Rodrigo Correa-Oliveira, PhD · Centro de Pesquisas René Rachou

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-06-30
Completion
2017-12-31

Countries

  • Brazil

Study Locations

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Entities

Companies

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 NCT02476773 on ClinicalTrials.gov