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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT02326194
Eligibility Criteria:
Inclusion Criteria:
* Aged between 18 and 60 years.
* Able to understand the content of informed consent and willing to sign the informed consent
* Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months).
* A body mass index (BMI) \<35
* Hemoglobin 110-150g/L for female, and 120-160g/L for male.
* White blood cells (WBC) 4.0-10.0×109 cells/L
* Total lymphocyte Count 0.8-4.5×109 cells/L
* Platelets 100-300×109 cells/L
* Alanine aminotransferase (ALT) 0-40U/L
* Serum creatinine 44-106μmol/L
* Partial thromboplastin time (PTT) 20-40 seconds
* Prothrombin time (PT) 10-14 seconds
* Negative in HIV diagnostic blood test
* Axillary temperature ≤37.0°C on the day of enrollment
* General good health as established by medical history and physical examination.
Exclusion Criteria:
* Family history of seizure, epilepsy, brain or mental disease
* Subject that has a medical history of any of the following: allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV vaccine, such as mannitol
* Woman who is pregnant, breast-feeding or positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months
* Any acute fever disease or infections in last 7 days
* Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease
* Hereditary angioneurotic edema or acquired angioneurotic edema
* Urticaria in last one year
* Asplenia or functional asplenia
* Platelet disorder or other bleeding disorder may cause injection contraindication
* Faint at the sight of blood or needles.
* Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months
* Prior administration of blood products in last 4 months
* Prior administration of other research medicines in last 1 month
* Prior administration of attenuated vaccine in last 1 month
* Prior administration of inactivated vaccine in last 14 days
* Current anti-tuberculosis prophylaxis or therapy
* Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02326194
Study Brief:
Protocol Section:
NCT02326194