Na-GST-1/Alhydrogel With or Without CpG 10104 in Gabonese Adults
Condition: Hookworm Infection; Hookworm Disease
MeSH terms: Hookworm Infections; Ancylostomiasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Na-GST-1 is a protein expressed during the adult stage of the Necator americanus hookworm
      life cycle that is thought to play a role in the parasite's degradation of host hemoglobin
      for use as an energy source. Vaccination with recombinant Na-GST-1 has protected dogs and
      hamsters from infection in challenge studies. This study will evaluate the safety and
      immunogenicity of administering Na-GST-1 with or without the CpG 10104 immunostimulant to
      healthy Gabonese adults living in an area of endemic hookworm infection.
    

Detailed description: 
      Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in
      hookworm-exposed adults aged 18 to 50 years living in the area of Lambaréné, Gabon.
      Participants will receive three doses of the assigned vaccine(s) delivered intramuscularly
      (deltoid) 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 final 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 a
      qualified indirect enzyme-linked immunosorbent assay (ELISA), on serum or plasma obtained
      prior to each study vaccination and at time points after each vaccination; the functional
      activity of vaccine-induced antibodies will be assessed by in vitro enzyme neutralization
      assays.

      Recruitment and enrollment into the study will occur on an ongoing basis, with each group
      being recruited and vaccinated in sequence.

      24 subjects will be enrolled into 2 groups:

        -  Group 1 (n=12):

             -  8 subjects will receive 30 µg Na-GST-1 plus 500 µg CPG 10104 delivered by IM
                injection in the deltoid muscle

             -  4 subjects will receive 100 µg Na-GST-1 delivered by IM injection in the deltoid
                muscle

        -  Group 2 (n=12):

             -  8 subjects will receive 100 µg Na-GST-1 plus 500 µg CPG 10104 delivered by IM
                injection in the deltoid muscle

             -  4 subjects will receive 100 µg Na-GST-1 delivered by IM injection in the deltoid
                muscle
    

Intervention name(s): Na-GST-1; CPG 10104
Intervention type(s): Biological; Biological
Intervention description(s): Na-GST-1/Alhydrogel®; CPG 10104
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Human Hookworm; Necator americanus; Hookworm; Hookworm Disease; Iron-deficiency anemia; Soil-transmitted helminth infection; Neglected Tropical Disease; Na-GST-1; CpG