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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT03625934
Eligibility Criteria:
Inclusion Criteria:
* Cohort 1: hepatits B vaccine naive subjects Seronegative for anti-HBs and anti-HBc antibodies and for HBs Antigen
* Cohort 2: Subjects who failed to develop a protective immune response upon standard vaccination with a licensed hepatitis B vaccine (\<10 IU/L anti HbS antibodies) Seronegative for anti-HbS (\<10 IU/L) and anti-HBc antibodies and for HbSAg
* Cohort 3: Parameters confirmed at screening during the past 12 months
1. HBeAg negative;
2. HbSAg positive at screening \<3000 IU/ml;
3. HBV viral load \<2000 IU/ml
4. ALT Levels ≤ULN at screening
* Cohort 4a: Parameters confirmed at screening during the last 12 months
1. HBeAg negative;
2. HbSAg positive \<1000 IU/ml
3. HBV DNA not detectable for at least 2 years
4. History of nucleos(t)die Treatment for at least 3 years
5. Willingness to discontinue NUC treatment during study
6. ALT levels ≤ULN at screening
* Cohort 4b: in addition to cohort 4a:
1. willingness to discontinue NUC treatment 6 weeks before entering the Study
2. ALT Levels ≤ULN 6 weeks before entering the study and
* 5x ULN at screening
Exclusion Criteria:
* Pregnant or breast-feeding females, adequate contraception required during the treatment phase
* History of grass pollen allergy
* Co-infection with HCV, HDV, HIV
* History of auto-immune hepatitis
* Elevated Levels of Alpha-Fetoprotein (AFP) \>100 ng/ml
* Documented history of decompensated liver disease (albumin \<3.5 g/dl and bilirubin \>1.3 mg/dl)
* Autoimmune disorders, transplant recipients, use of immunosuppressive or immune modulating agents
* Oral corticosteroids of 20 mg/week within the past 4 weeks prior to screening
* History of treatment with PEG-IFN of IFN for at least 1 year prior to screening
* History of evidence or conditions associated with chronic liver disease
* Acute fever at time of enrolment
* History of alcohol abuse
* Planned administration of a vaccine not foreseen by study protocol in the period starting 30 days before first product administration and during the entire study period with exception of influenza vaccine
* History of Cancer
* Other severe co-morbid conditions and concurrent medication making the subject unsuitable for participation
* blood or plasma donation within 1 month of study enrolement and during the course of the study
* For all patients with chronic HBV infection:
1. Total bilirubin \>2x ULN confirmed by repeat testing within 2 weeks, unless historical documentation of Gilbert's syndrome
2. Documented or suspected hepatocelluar carcinoma
3. Presence of cholangitis, cholecystitis or bile duct obstruction
4. Liver cirrhosis assessed by fibroscan with elastography \<9kPa within the previous 12 months and FIB-score \<3.2 at study entry
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03625934
Study Brief:
Protocol Section:
NCT03625934