Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT01717950
Eligibility Criteria:
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 of a coagulopathy (PTT or PT INR greater than 1.1-times the upper reference limit).
* Serum glucose (random) greater than 1.2-times the upper reference limit.
* Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
* Participation in another investigational vaccine or drug trial within 30 days of starting this study.
* Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
* History of a severe allergic reaction or anaphylaxis.
* Severe asthma as defined by the need for daily use of inhalers or emergency clinic visit or hospitalization within 6 months of the volunteer's expected first vaccination in the study.
* Positive ELISA for hepatitis B surface antigen (HBsAg).
* Positive confirmatory test for HIV infection.
* Positive confirmatory test for hepatitis C virus (HCV) infection.
* Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of the volunteer's expected first vaccination in this study.
* Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to the volunteer's expected first vaccination in the study.
* History of a surgical splenectomy.
* Receipt of blood products within the past 6 months.
* History of previous infection with hookworm or residence for more than 6 months in a hookworm-endemic area.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01717950
Study Brief:
Protocol Section:
NCT01717950