NCT02126462

Randomized, Controlled, Phase 1 Study to Assess Safety and Immunogenicity of Co-administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 Adjuvanted With Alhydrogel® and Gluco-pyranosylphospho-lipid A in Gabonese Adults

Completed Phase 1 Last updated 30 May 2017

What this trial tests

Phase 1 trial testing Na-APR-1 (M74)/Alhydrogel® in Hookworm Infection in 32 participants. Completed in 1 June 2016.

Timeline

1 November 2014

Primary endpoint
1 February 2016

1 June 2016

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	32
Start date	1 November 2014
Primary completion	1 February 2016
Estimated completion	1 June 2016
Sites	1 location across Gabon

Drugs / interventions tested

• Na-APR-1 (M74)/Alhydrogel®
• Na-GST-1/Alhydrogel®
• Hepatitis B vaccine — full drug profile →

Conditions studied

• Hookworm Infection — all drugs for Hookworm Infection →
• Hookworm Disease — all drugs for Hookworm Disease →

Sponsor

Baylor College of Medicine

Who can join

Adults 18 to 50, any sex, with Hookworm Infection or Hookworm Disease. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Vaccine-related Adverse Events
  Time frame: Day 360
  To estimate the frequency of vaccine-related adverse events, graded by severity, for each dose of co-administered Na-GST-1 and Na-APR-1 (M74). The frequency of immediate, systemic, and local injection site adverse events will be summarized. Adverse events will be assessed by study team members at 1 hour post-vaccination as well as 1, 3, 7, 14, and 28 days following each vaccination.

Sponsor's own description

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 with 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 Gabonese adults living in an area of endemic hookworm infection.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and immunogenicity of co-administered hookworm vaccine candidates Na-GST-1 and Na-APR-1 in Gabonese adults: a randomised, controlled, double-blind, phase 1 dose-escalation trial.
   Adegnika AA, de Vries SG, Zinsou FJ, Honkepehedji YJ, et al · · 2021 · cited 30× · PMID 32926834 · DOI 10.1016/s1473-3099(20)30288-7
2. Characterization of T cell responses to co-administered hookworm vaccine candidates Na-GST-1 and Na-APR-1 in healthy adults in Gabon.
   Mouwenda YD, Betouke Ongwe ME, Sonnet F, Stam KA, et al · · 2021 · cited 11× · PMID 34597297 · DOI 10.1371/journal.pntd.0009732
3. Investigation of urinary metabolomics in a phase I hookworm vaccine trial in Gabon.
   Betouke Ongwe ME, Mouwenda YD, Stam KA, Kremsner PG, et al · · 2022 · PMID 36155987 · DOI 10.1371/journal.pone.0275013