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Study of Co-administered Na-APR-1 (M74) and Na-GST-1 in Gabonese Children

NCT02839161 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-01-13

Study results available
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Summary

Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in hookworm-exposed children aged 6 to 10 years living in the area of Lambaréné, Gabon. Children will receive three doses of the Na-GST-1/Alhydrogel hookworm vaccine co-administered with the Na-APR-1 (M74)/Alhydrogel hookworm vaccine or the hepatitis B vaccine co-administered with sterile saline. All injections will be delivered intramuscularly (deltoid) on approximately Days 0, 56, and 112 or 180.

Conditions

  • Hookworm Disease
  • Hookworm Infection

Interventions

BIOLOGICAL

Na-GST-1/Alhydrogel

BIOLOGICAL

Na-APR-1 (M74)/Alhydrogel

BIOLOGICAL

Hepatitis B Vaccine

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Ayola Adegnika, MD · Centre de Recherches Medicales de Lambaréné

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-12-13
Completion
2019-03-28

Countries

  • Gabon

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 NCT02839161 on ClinicalTrials.gov