Safety and Immunogenicity Study of Na-GST-1 With or Without CpG (NCT02143518) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity Study of Na-GST-1 With or Without CpG
United States24 participantsStarted 2014-10
Plain-language summary
Na-GST-1 is a protein expressed during the adult stage of the hookworm life cycle that is thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination with recombinant GST-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of two formulations of Na-GST-1 in healthy adult volunteers when co-administered with the immunostimulant CpG 10104, a Toll-like Receptor-9 agonist.
Who can participate
Age range18 Years – 50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (68 weeks).
* Willingness to participate in the study as evidenced by signing the informed consent document.
* Able to understand and comply with planned study procedures.
Exclusion Criteria:
* Pregnancy as determined by a positive urine human choriogonadotropin (hCG) test (if female).
* Participant unwilling to use reliable contraception up until one month following the third immunization (if female and not surgically sterile, abstinent, at least 2 years post-menopausal, or determined otherwise by medical evaluation to be sterile).
* 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. A history of essential hypertension that is well controlled by medication will not be considered exclusionary.
* Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric condition that would make compliance with study visits/procedures difficult (e.g., subject with psychoses or history of suicide attempt or gesture in the 3 years before study entry, ongoing risk for suicide).
* Known or suspected immunodeficiency.
* Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater th…