Safety and Immunogenicity of the Na-APR-1 Hookworm Vaccine in Healthy Adults (NCT01717950) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity of the Na-APR-1 Hookworm Vaccine in Healthy Adults
United States40 participantsStarted 2013-09
Plain-language summary
Hookworms digest hemoglobin from erythrocytes for use as an energy source via a proteolytic cascade that begins with the aspartic protease, APR-1. Vaccination with recombinant APR-1 has protected animals from infection in challenge studies. This study will evaluate the safety and immunogenicity of two formulations of Na-APR-1 (M74) in healthy adult volunteers when co-administered with different concentrations of the immunostimulant GLA-AF.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Males or females between 18 and 50 years, inclusive.
* Good general health as determined by means of the screening procedure.
* Available for the duration of the trial (44 weeks).
* Willingness to participate in the study as evidenced by signing the informed consent document.
Exclusion Criteria:
* Pregnancy as determined by a positive urine human choriogonadotropin (hCG) (if female).
* Participant unwilling to use reliable contraception methods up until one month following the third immunization (if female and not surgically sterile, abstinent or at least 2 years post-menopausal).
* 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 \<11.5 g/dl \[females\] or \<12.5 g/dl \[males\]; absolute leukocyte count \<3600/mm3 or \>10.7 x 103/mm3; absolute neutrophil count \[ANC\] \<1700/ mm3; absolute lymphocyte count \<700/mm3; or platelet count \<140,000/mm3).
* Laboratory evidence …