Study of Na-APR-1 (M74)/Alhydrogel® Co-administered With

Status Completed

Clinical Trial 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.

Clinical Trial Description

Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in hookworm exposed adults living in the area of Americaninhas, Minas Gerais, Brazil. Subjects will receive three doses of the assigned vaccine delivered intramuscularly on approximately Days 0, 56, and 112.

Safety will be measured from the time of each study vaccination (Day 0) through 14 days after each study vaccination by the occurrence of solicited injection site and systemic reactogenicity events.

Unsolicited non-serious adverse events (AEs) will be collected from the time of the first study vaccination through approximately 1 month after each study vaccination. New-onset chronic medical conditions and Serious Adverse Events (SAEs) will be collected from the time of the first study vaccination through approximately 9 months after the third study vaccination (final visit). Clinical laboratory evaluations for safety will be performed on venous blood collected approximately 14 days after each vaccination.

Immunogenicity testing will include IgG antibody responses to each vaccine antigen, by an indirect enzyme-linked immunosorbent assay (ELISA) and also by ImmunoCAP, on serum obtained prior to each study vaccination and at time points after each vaccination; antibody affinity by Surface Plasmon Resonance; functional activity of vaccine-induced antibodies via in vitro enzyme neutralization assays; and, antigen-specific memory B cell responses.

Recruitment and enrollment into the study will occur on an ongoing basis, with each group being recruited and vaccinated in sequence.

60 subjects will be enrolled into 6 groups of 10. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02476773
Study type	Interventional
Source	Baylor College of Medicine
Contact
Status	Completed
Phase	Phase 1
Start date	January 2016
Completion date	December 2017

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT02126462` - Safety and Immunogenicity of Co-Administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 in Gabonese Adults	Phase 1
Completed	`NCT01261130` - Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With or Without Additional Adjuvant in Brazilian Adults	Phase 1
Completed	`NCT01385189` - Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel Adjuvant	Phase 1
Terminated	`NCT00473967` - Phase 1 Trial of Na-ASP-2 Hookworm Vaccine in Previously Infected Brazilian Adults	Phase 1
Completed	`NCT00603889` - Development of a Skin Test for the Na-ASP-2 Hookworm Antigen	N/A
Completed	`NCT02839161` - Study of Co-administered Na-APR-1 (M74) and Na-GST-1 in Gabonese Children	Phase 1
Recruiting	`NCT01940757` - Experimental Infection of Hookworm-naïve Adults With Dermally-applied Infectious Necator Americanus Hookworm Larvae	Phase 1
Completed	`NCT00207753` - Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections	N/A
Completed	`NCT03373214` - Na-GST-1/Alhydrogel With or Without CpG 10104 in Gabonese Adults	Phase 1
Completed	`NCT00939198` - Prevalence of Hookworm Infection and Community Preparedness for Hookworm Vaccine Trials in Endemic Areas of Brazil	N/A
Active, not recruiting	`NCT02262403` - Hookworm Immune Regulation Project	N/A
Completed	`NCT00120081` - Study of Na-ASP-2 Human Hookworm Vaccine in Healthy Adults Without Evidence of Hookworm Infection	Phase 1
Recruiting	`NCT05914363` - Evaluating Impact of Improved Floors on Health	N/A

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.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms