Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel Adjuvant
Condition: Hookworm Infection; Hookworm Disease
MeSH terms: Hookworm Infections; Ancylostomiasis
Intervention: 10 μg Na-GST-1/Alhydrogel; 30 μg Na-GST-1/Alhydrogel; 100 μg Na-GST-1/Alhydrogel; 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg); 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg); 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg); 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
Intervention description: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals; 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals; 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals; 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals; 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals; 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals; 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals
Intervention MeSH terms: Aluminum Hydroxide
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human Hookworm Vaccine Initiative; HHVI; Human Hookworm; Hookworm; Hookworm Disease; N. americanus; Soil-transmitted helminth infection; Intestinal blood loss; Iron deficiency anemia

Summary:

      This study is designed to evaluate the safety, reactogenicity, and immunogenicity of Na-GST-1
      adsorbed to Alhydrogel® with or without two different dose concentrations of a novel
      adjuvant, GLA-AF (1 µg or 5 μg) among healthy adult volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females between 18 and 45 years, inclusive.

          -  Good general health as determined by means of the screening procedure.

          -  Available for the duration of the trial (16 months).

          -  Willingness to participate in the study as evidenced by signing the informed consent
             document.

        Exclusion Criteria:

          -  Pregnancy as determined by a positive urine β-hCG (if female).

          -  Participant unwilling to use reliable contraception methods up until one month
             following the third immunization (if female).

          -  Currently lactating and breast-feeding (if female).

          -  Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic,
             rheumatologic, autoimmune, diabetes, or renal disease by history, physical
             examination, and/or laboratory studies.

          -  Known or suspected immunodeficiency.

          -  Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than
             1.25-times the upper reference limit).

          -  Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the
             upper reference limit, or more than trace protein or blood on urine dipstick testing).

          -  Laboratory evidence of hematologic disease (hemoglobin <12.5 g/dl [females] or <13.5
             g/dl [males]; absolute leukocyte count <3500/mm-cubed or >10.5 x 103/mm-cubed;
             absolute neutrophil count [ANC] <2000/ mm-cubed; absolute lymphocyte count
             <1100/mm-cubed; or platelet count <140,000/mm-cubed).

          -  Laboratory evidence of a coagulopathy (PTT or PT INR greater than 1.1-times the upper
             reference limit).

          -  Serum glucose (random) greater than 1.2-times the upper reference limit.

          -  Other condition that in the opinion of the investigator would jeopardize the safety or
             rights of a volunteer participating in the trial or would render the subject unable to
             comply with the protocol.

          -  Participation in another investigational vaccine or drug trial within 30 days of
             starting this study.

          -  Volunteer has had medical, occupational, or family problems as a result of alcohol or
             illicit drug use during the past 12 months.

          -  History of a severe allergic reaction or anaphylaxis.

          -  Severe asthma as defined by the need for regular use of inhalers or emergency clinic
             visit or hospitalization within the last 6 months.

          -  Positive ELISA for HBsAg.

          -  Positive ELISA and confirmatory Western blot tests for HIV-1.

          -  Positive ELISA and confirmatory immunoblot tests for HCV.

          -  Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within
             30 days of starting this study.

          -  Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks
             prior to entry into the study.

          -  History of a surgical splenectomy.

          -  Receipt of blood products within the past 6 months.

          -  History of allergy to yeast.

          -  History of previous infection with hookworm or residence for more than 6 months in a
             hookworm-endemic area.