Na-GST-1/Alhydrogel With or Without CpG 10104 in Gabonese Adults (NCT03373214) | Clinical Trial Compass
CompletedPhase 1
Na-GST-1/Alhydrogel With or Without CpG 10104 in Gabonese Adults
Gabon24 participantsStarted 2018-02-01
Plain-language summary
Na-GST-1 is a protein expressed during the adult stage of the Necator americanus 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 Na-GST-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of administering Na-GST-1 with or without the CpG 10104 immunostimulant 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 the study area.
✓. Good general health as determined by means of the screening procedure.
✓. Assumed availability for the duration of the trial (13 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 human choriogonadotropin (hCG) test (if female).
✕. Participant unwilling to use reliable contraception up until one month following the final 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).
✕. 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.
✕. 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).