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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT05909358
Eligibility Criteria:
Inclusion Criteria:
Phase 1
* Healthy volunteers aged 18-50 years from study communities
* Healthy volunteers with a permanent home address
* Able and willing to complete and provide written informed consent. In case the participant cannot read or write, the procedures must be explained to him/her and informed consent must be witnessed by a literate third party not involved with the conduct of the study
* Participant must pass the informed consent test of understanding (TOU)
* Participant must be healthy in the investigator's clinical judgement on the basis of medical history, physical examination, vital signs and point of care tests (where applicable) performed at screening
* If female of child-bearing potential and heterosexually active, practice of adequate contraception for 28 days prior to injection, negative pregnancy test on the day of vaccination, and agreement to continue adequate contraception until 90 days after vaccination
* Male participants are eligible to participate in the study if they agree to use a male condom during any heterosexual intercourse with a female of childbearing potential until 90 days after vaccination
Phase 2
* Healthy volunteers aged 6 years-65 years from study communities. Individuals with comorbidities assessed as stable will be allowed to participate
* With a permanent home address
* Able and willing to complete and provide written informed consent or assent as applicable. In case the participant cannot read or write, the procedures must be explained to him/her, and informed consent must be witnessed by a literate third party not involved with the conduct of the study.
* Participant must pass the informed consent or assent test of understanding (TOU)
* Participant must be healthy according to the investigator's clinical judgement on the basis of medical history, physical examination, vital signs and point of care tests (where applicable) performed at screening
* If female of child-bearing potential and heterosexually active, practice of adequate contraception for 28 days prior to injection, negative pregnancy test on the day of vaccination, and agreement to continue adequate contraception until 180 days after vaccination
* Male participants are eligible to participate in the study if they agree to abstain from any heterosexual intercourse with a female of childbearing potential or must agree to use a male condom
Exclusion Criteria:
Phase 1
* History of confirmed ebola virus diseases (SUDV, EBOV or BUDV)
* Unwillingness of female participants to use effective contraception
* Participation in an interventional clinical trial within 90 days of participation in this trial
* Prior vaccination with any Ebola vaccine
* Breastfeeding or planning to conceive within 2 months following study vaccination
* Has history of fever (\>100.4ºF/38.0ºC) within 48 hours prior to enrolment into the study
* Received systemic corticosteroids exceeding physiologic replacement doses (\~5 mg/d prednisone equivalent) within 14 days prior to study entry
* Received any live virus vaccine within 30 days or any non-live virus vaccine within 14 days prior to study entry
* Has a known allergy/sensitivity or contraindication to investigational vaccines or its/their excipients?
* History of malignancy ≤5 years
* Major surgery within the 4 weeks prior to screening or planned major surgery through the course of the study (from screening until completion of the study)
* Presence of any condition that can interfere with the subject's participation for the full duration of the trial.
* HIV positive
* Hepatitis B positive
Phase 2
* History of confirmed SUDV
* Unwillingness of female participants to use effective contraception
* Participation in an interventional clinical trial within 90 days of start of this trial
* Prior vaccination with any Ebola vaccine
* Breastfeeding or planning to conceive within 2 months following study vaccination
* Has history of fever (\>100.4ºF/38.0ºC) within 48 hours prior to vaccination
* Received systemic corticosteroids exceeding physiologic replacement doses (\~20 mg/d prednisone or equivalent) for 14 days within a month prior to study entry.
* Immunosuppressive medication within 3 months
* Received any live virus vaccine within 30 days or any non-live virus vaccine within 14 days prior to study entry
* Has a known allergy/sensitivity or contraindication to investigational vaccines or its/their excipients?
* History of malignancy ≤5 years
* Major surgery within the 4 weeks prior to screening or planned major surgery through the course of the study (from screening until completion of the study)
* Presence of any condition that can interfere with the subject's participation for the full duration of the trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
65 Years
Study:
NCT05909358
Study Brief:
Protocol Section:
NCT05909358