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 @ 12:46 PM
Ignite Modification Date:
2025-12-24 @ 12:46 PM
NCT ID:
NCT02996461
Eligibility Criteria:
* INCLUSION CRITERIA:
A subject must meet all of the following criteria:
* 18 to 50 years old
* Available for clinic visits for 24 months after enrollment
* Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
* Able and willing to complete the informed consent process
* Willing to donate blood for sample storage to be used for future research
* In good general health without clinically significant medical history
* Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) less than or equal to 40 within the 56 days prior to enrollment
* Agrees not to receive licensed or investigational flavivirus vaccines through 4 weeks after last product administration
* Laboratory Criteria within 56 days prior to enrollment:
* Hemoglobin within institutional normal limits or accompanied by the site Principal Investigator (PI) or designee approval
* WBC and differential either within institutional normal range or accompanied by site PI or designee approval
* Total lymphocyte count greater than or equal to 800 cells/mm\^3
* Platelets = 125,000 - 500,000/mm\^3
* Alanine aminotransferase (ALT) less than or equal to 1.25 x institutional upper limit of normal (ULN)
* Serum creatinine less than or equal to 1.1 x institutional ULN
* Negative for HIV infection by an FDA approved method of detection
* Criteria applicable to women of childbearing potential:
* Negative human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on day of enrollment
* Agrees to use an effective means of birth control from at least 21 days prior to enrollment through 12 weeks after the last study vaccination
EXCLUSION CRITERIA:
A subject will be excluded if one or more of the following conditions apply:
* Female-specific: Breast-feeding or planning to become pregnant while participating through 12 weeks after the last study vaccination
* Subject has received any of the following:
* More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment
* Blood products within 16 weeks prior to enrollment
* Inactivated vaccines within 2 weeks prior to enrollment
* Live attenuated vaccines within 4 weeks prior to enrollment
* Investigational research products within 4 weeks prior to enrollment or planning to receive investigational products while on the study
* Current allergen immunotherapy with antigen injections, unless on maintenance schedule
* Current anti-TB prophylaxis or therapy
* Subject has a history of any of the following clinically significant conditions:
* Laboratory confirmed ZIKV infection by self-report at the time of enrollment
* Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the site investigator
* Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
* Asthma that is not well controlled
* Diabetes mellitus (type I or II), with the exception of gestational diabetes
* Evidence of autoimmune disease or immunodeficiency
* Idiopathic urticaria within the past year
* Hypertension that is not well controlled
* Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
* Malignancy that is active or history of malignancy that is likely to recur during the period of the study
* Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years
* Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
* Guillain-Barre Syndrome, Bell's palsy or similar neurological conditions
* Psychiatric condition that precludes compliance with the protocol; past or present psychoses; or within 5 years prior to enrollment, a history of suicide plan or attempt
* Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02996461
Study Brief:
Protocol Section:
NCT02996461