Safety & Immunogenicity of the Na-APR-1 Hookworm Vaccine in Healthy Adults

Status Completed

Clinical Trial Summary

Hookworms digest hemoglobin from erythrocytes for use as an energy source via a proteolytic cascade that begins with the aspartic protease, APR-1. Vaccination with recombinant APR-1 has protected animals from infection in challenge studies. This study will evaluate the safety and immunogenicity of two formulations of Na-APR-1 (M74) in healthy adult volunteers when co-administered with different concentrations of the immunostimulant GLA-AF.

Clinical Trial Description

Open-label, dose-escalation phase 1 clinical trial in healthy, hookworm-naïve adults:

- Study site: George Washington Medical Faculty Associates, Washington, DC

- Number of participants: 40 in 2 cohorts of 20.

In Cohort 1 five (5) volunteers will receive 30 µg Na-APR-1 (M74) /Alhydrogel®, five (5) will receive 30 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF, and ten (10) will receive 30 µg Na-APR-1 (M74) /Alhydrogel® plus 5 µg GLA-AF. In Cohort 2 five (5) volunteers will receive 100 µg Na-APR-1 (M74)/Alhydrogel®, five (5) will receive 100 µg Na-APR-1 (M74) /Alhydrogel® plus 2.5 µg GLA-AF, and ten (10) will receive 100 µg Na-APR-1 (M74)/Alhydrogel® plus 5 µg GLA-AF.

The cohorts will be enrolled in a staggered fashion with safety data assessed prior to the Na-APR-1 dose escalation from 30 to 100 µg. In addition, within each cohort, vaccinations will be staggered such that formulations containing 0, 2.5, and 5 µg GLA-AF will be tested sequentially: for example, those receiving Na-APR-1 (M74)/Alhydrogel® in combination with 2.5 µg GLA-AF will be vaccinated no sooner than 3 days after the last volunteer is vaccinated with the formulation containing no GLA-AF, whereas those vaccinated with Na-APR-1 (M74)/Alhydrogel® plus 5 µg GLA-AF will be vaccinated no sooner than 7 days after the last one receives the 2.5 µg GLA-AF formulation.

- Immunization schedule: Study days 0, 56 and 112.

- Route: IM in the deltoid muscle.

- Doses of Na-APR-1 (M74) to be tested: 30 and 100 µg.

- Doses of Alhydrogel®: 240 and 800 µg for the 30 and 100 µg doses of Na-APR-1 (M74), respectively.

- Doses of GLA-AF to be tested: 2.5 µg and 5 µg.

- Study duration: 44 weeks (10 months) per study participant; total duration of the study estimated at approximately 13 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01717950
Study type	Interventional
Source	Baylor College of Medicine
Contact
Status	Completed
Phase	Phase 1
Start date	September 2013
Completion date	September 2015

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Safety and Immunogenicity of the Na-APR-1 Hookworm Vaccine in Healthy Adults

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms