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:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT05469802
Eligibility Criteria:
Inclusion Criteria:
1. Healthy participants.
2. Participants who can comply with trial procedures (including new trial technologies) and are available for the duration of follow-up.
3. All females of childbearing potential must have a negative urine beta human chorionic gonadotropin (β-hCG) pregnancy test prior to receiving any dose.
Exclusion Criteria:
1. Participants with past or current ZIKV infection by self-report.
2. Participants with past or current dengue virus, yellow fever virus, Japanese encephalitis virus, tick-borne encephalitis virus or West Nile virus infection by self-report.
Participants who have travelled to dengue and/or Zika endemic countries and US regions and territories\*, or who plan to travel to these countries/regions within 1 month prior to anticipated enrollment up to 1 month post dose 2.
\*Centers for Disease Control and Prevention (CDC) website describes dengue/Zika endemic countries and US regions and territories.
3. Participants with any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barré syndrome).
4. Participants with known or suspected impairment/alteration of immune function, including:
1. Chronic use of oral or parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks / ≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
2. Receipt of immunomodulatory agents within 60 days prior to Day 1.
3. Receipt of parenteral, epidural or intra-articular immunoglobulin preparation, blood products, and/or plasma derived products within 3 months prior to Day 1 or planned receipt during the full length of the trial. In addition, participants must be advised not to donate blood during the study period.
4. Known Human Immunodeficiency Virus (HIV) infection or HIV-related disease.
5. Genetic immunodeficiency.
5. Participants with known current or chronic hepatitis B and/or hepatitis C infections.
6. Participants with abnormalities of splenic or thymic function.
7. Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
8. Participants with any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, insulin-dependent diabetes, cardiac, renal, hepatic or thyroid disease, uncontrolled hypertension, uncontrolled asthma).
9. Participants with a history of substance or alcohol abuse within the past 2 years.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT05469802
Study Brief:
Protocol Section:
NCT05469802