Study of Co-administered Na-APR-1 (M74) and Na-GST-1 in Gabonese Children
Condition: Hookworm Disease; Hookworm Infection
MeSH terms: Hookworm Infections; Ancylostomiasis
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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 assigned vaccine(s) delivered intramuscularly (deltoid) on
      approximately Days 0, 56, and 112 or 180.

      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 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 (see Appendix A);
      the functional activity of vaccine-induced antibodies will be assessed by in vitro enzyme
      neutralization assays; the induction of B cell memory will be measured by 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 3 groups of 20. The first 20 subjects will be assembled and
      enrolled into Group 1:

        1. Group 1 double-blind IP allocation (n=20):

             -  16 subjects will receive 10 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM
                injection in the deltoid muscle, with 10 µg Na-GST-1 administered IM in the
                alternate arm.

                  -  8 will be vaccinated according to a 0,2,4-month schedule

                  -  8 will be vaccinated according to a 0,2,6-month schedule

             -  4 subjects will receive hepatitis B vaccine comparator:

                  -  2 will be vaccinated according to a 0,2,4-month schedule

                  -  2 will be vaccinated according to a 0,2,6-month schedule

        2. Group 2 double-blind IP allocation (n=20):

             -  16 subjects will receive 30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM
                injection in the deltoid muscle, with 30µg Na-GST-1 administered IM in the
                alternate arm.

                  -  8 will be vaccinated according to a 0,2,4-month schedule

                  -  8 will be vaccinated according to a 0,2,6-month schedule

             -  4 subjects will receive hepatitis B vaccine comparator:

                  -  2 will be vaccinated according to a 0,2,4-month schedule

                  -  2 will be vaccinated according to a 0,2,6-month schedule

        3. Group 3 double-blind IP allocation (n=20):

             -  16 subjects will receive 100 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM
                injection in the deltoid muscle, with 100 µg Na-GST-1 administered IM in the
                alternate arm.

                  -  8 will be vaccinated according to a 0,2,4-month schedule

                  -  8 will be vaccinated according to a 0,2,6-month schedule

             -  4 subjects will receive hepatitis B vaccine comparator:

                  -  2 will be vaccinated according to a 0,2,4-month schedule

                  -  2 will be vaccinated according to a 0,2,6-month schedule
    

Intervention name(s): Na-GST-1/Alhydrogel; Na-APR-1 (M74)/Alhydrogel; Hepatitis B Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hookworm; Vaccine; Na-GST-1; Na-APR-1; Necator americanus