Efficacy of Na-GST-1/Alhydrogel Hookworm Vaccine Assessed by Controlled Challenge Infection (NCT03172975) | Clinical Trial Compass
CompletedPhase 2
Efficacy of Na-GST-1/Alhydrogel Hookworm Vaccine Assessed by Controlled Challenge Infection
United States39 participantsStarted 2018-03-01
Plain-language summary
This study evaluates the efficacy, safety and immunogenicity of different formulations of the Na-GST-1 hookworm vaccine using a controlled human hookworm infection model in healthy, hookworm-naive adults.
Who can participate
Age range18 Years ā 45 Years
SexALL
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Inclusion criteria
ā. Males and non-pregnant females between 18 and 45 years, inclusive.
ā. Good general health as determined by means of the screening procedures1.
ā. Available for the duration of individual subject study participation (14 months).
ā. Willingness to participate in the study as evidenced by signing the informed consent document.
ā. Able to understand and comply with planned study procedures.
Exclusion criteria
ā. Pregnancy as determined by a positive urine human choriogonadotropin (hCG) test (if female).
ā. Subject unwilling to use effective contraception for a minimum of 30 days prior to vaccination and up until documentation of clearance of hookworm infection post-CHHI (if female and not surgically sterile, abstinent from intercourse with a male partner, in a monogamous relationship with a vasectomized partner, at least 2 years post-menopausal, or determined otherwise by medical evaluation to be sterile).
ā. Currently lactating and breast-feeding or plans to breastfeed at any given time from the first study vaccination until clearance of hookworm infection post-CHHI (if female).
ā. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, gastrointestinal, diabetes, or renal disease by history, physical examination, and/or laboratory studies.
ā. 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).
What they're measuring
1
Detectable Hookworm Infection
Timeframe: On Study Days 175, 182, 189, 203, 217, 231, 245, 259, 273, and 280.
2
Incidence of Serious Adverse Events
Timeframe: Beginning on Day 0 when the first dose is received and ending on Day 380 (final study visit).
3
Incidence of Solicited Injection Site and Systemic Reactogenicity
Timeframe: Dose 1: Days 0, 3, 7, 14; Dose 2: Days 56, 59, 63, 70; Dose 3: Days 112, 115, 119, 126
4
Incidence of Solicited Adverse Events
Timeframe: Day of CHHI, Day 140, and study days: 143, 147, 154, 175, 182, 189, 196, 203, 210, 217, 224, 231, 238, 245, 252, 259, 266, 273, 280. Day 280 is the day of anti-worm treatment.
5
Incidence of Clinical Safety Laboratory Abnormalities
ā. Known or suspected immunodeficiency or immunosuppression as a result of an underlying illness or treatment (causes for immunosuppression may include, but are not limited to, poorly-controlled diabetes mellitus, chronic liver disease, renal insufficiency, active neoplastic disease or a history of hematologic malignancy, connective tissue disease, organ transplant).
ā. Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than 1.25-times the upper reference limit).
ā. Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the upper reference limit, or urine dipstick testing positive for glucose or more than trace protein).
8
Incidence of Adverse Events of Special Interest
Timeframe: Entire duration of the study. Beginning Day 0, day of first dose, until Day 380, final study visit.