Safety and Immunogenicity of Co-Administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 in… (NCT02126462) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity of Co-Administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 in Gabonese Adults
Gabon32 participantsStarted 2014-11
Plain-language summary
Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator americanus hookworm life cycle that are thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination with recombinant GST-1 or APR-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Gabonese adults living in an area of endemic hookworm infection.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Males or females between 18 and 50 years, inclusive, who are long-term residents of Gabon.
* Good general health as determined by means of the screening procedure.
* Assumed availability for the duration of the trial (12 months).
* Willingness to participate in the study as evidenced by signing the informed consent document.
* Negative for hookworm during screening, or if found to be infected with hookworm, has completed a course of three doses of albendazole.
Exclusion Criteria:
* Pregnancy as determined by a positive urine hCG (if female).
* Participant unwilling to use reliable contraception 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).
* Inability to correctly answer all questions on the informed consent comprehension questionnaire.
* 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 (absolu…