Testing of a therapeutic synthetic long peptide vaccination strategy for patients with a chronic Hepatitis B virus infectio
- Conditions
- HBeAg negative chronic HBVMedDRA version: 20.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2022-002194-28-NL
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 24
• Chronic HBV.
• Receiving treatment at the time of study entry and for greater than or equal to 12 months prior to study entry with HBV-active nucleos(t)ides, with tenofovir- or entecavir-containing therapy: tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), or entecavir.
• Positive HBsAg for more than 6 months before screening.
• Negative for HBeAg for more than 6 months before screening.
• HBV DNA < limit of quantification (20 IU/ml; CAP-CTM Roche Cobas).
• Available serum ALT values (within 1x ULN) for 2 different time points 14 days apart during the six months before the first dose of study drug with at least one of the determinations obtained during the screening period.
• Available liver biopsy or fibroscan within 12 months before inclusion indicating F0-F1 fibrosis.
• Willing to comply with effective contraception during the study if subject is male or woman of child bearing potential, up to 12 months after the vaccine administration.
• Patients must be = 18 and = 65 years of age and must be able to give written informed consent.
• Body mass index (BMI) = 18.0 and < 32.0 kg/m2.
• Ability to return to the hospital for adequate follow-up as required by this protocol.
• The ability to communicate well with the Investigator in the Dutch or English language.
• Written informed consent according to ICH-GCP.
• Willing to comply with the study restrictions.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Co-infection with HCV, HIV, HDV, HEV.
• Immune-compromised.
• History or evidence of chronic airway or cardiac disease.
• History of severe seizure disorder or current anticonvulsant use and clinically unstable disease.
• Unstable ongoing severe psychiatric disease, especially depression (stable patients can be included).
• Evidence of active or suspected cancer or history of malignancy with recurrence risk >20% within 5 years.
• Current chronic, acute, or recurrent bacterial, fungal, or viral infection that is – in the opinion of the treating MD- serious and requires systemic therapy (within 30 days prior to screening).
• Major organ transplantation.
• Previously received any systemic anti-viral, anti-neoplastic, immunosuppressive or immuno-modulatory treatment other than Tamiflu, acyclovir for herpetic lesions or NUC (including supraphysiologic doses of steroids or radiation) within 3 months prior to inclusion or the expectation that such treatment will be needed at any time during the study.
• History of HDV, HAV, HIV. Determined as positive within 12 months before start of study for anti-HDV, anti-HAV IgM, anti-HIV.
• Patients who are expected to need systemic antiviral therapy other than that provided by the study or Tamiflu at any time during their participation in the study. Exception: patients who have had a limited (<7 day) course of acyclovir for herpetic lesions more than 1 month prior to inclusion are not excluded.
• Evidence of liver cirrhosis (Child Pugh A-B-C).
• Serum total bilirubin > 2xULN at screening.
• History or evidence of bleeding from oesophageal varices or other conditions consistent with decompensated liver disease.
• History or evidence of a medical condition associated with chronic liver disease other than HBV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver diseases including Wilson's disease and alfa1-antitrypsin deficiency, alcoholic liver disease, toxin exposures, thalassemia).
• Hepatic steatosis on ultrasound in the absence of conditions mentioned above and in absence of liver fibrosis (histology or fibroscan F0-F1) and with elevated serum ALT.
• Women with ongoing pregnancy or who are breast feeding.
• Neutrophil count <1.500 cells/mm3 or platelet count <80.000 cells/mm3 at screening.
• Hemoglobin <7.1 mmol/L (<11.5 g/dL) for females and <7.8 mmol/L (<12.5 g/dL) for men at screening.
• Serum creatinine level >1.5xULN at screening.
• Patients with alfa-fetoprotein >2xULN, unless stability (less than 10% increase) has been documented over at least the previous 3 months.
• Evidence of current hard drug(s) use and/or alcohol abuse (>20g/day for women and >30g/day for men)
• Other routine vaccination within 14 days before any treatment day or 14 days after the last treatment day, nor booster vaccination during treatment days.
• Participation in an investigational drug, vaccine or device study* within 3 months prior to screening or more than 4 times a year.*Excluding donation of body materials for biobanking or research only.
• Documented allergy to the vaccine or one of its components.
• History or evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
• Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including blood chemistry, haematology and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be rep
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method