Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel Adjuvant

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.