Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel A… (NCT01385189) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel Adjuvant
United States40 participantsStarted 2012-05
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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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 refere…