NL-OMON51362尚未招募不适用
A single-center, double-blind, randomized, phase I/II dose escalating study to assess the safety, tolerability and immunogenicity of three doses of the therapeutic synthetic long peptide (SLP) vaccine (ISA104) in patients with chronic hepatitis B (cHBV). - HEB-PEP
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •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 <= 55 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
- •The ability to communicate well with the Investigator in the Dutch or English
- •Written informed consent according to ICH-GCP.
- •Willing to comply with the study restrictions.
排除标准
- •Co-infection with HCV, HIV, HDV, HEV.
- •Immune-compromised (known or expected immune deficiency, disease, or use of
- •medication that may affect the immune system).
- •History or other evidence of chronic airway or cardiac disease.
- •History of a 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 an active or suspected cancer or a history of malignancy where
- •the risk of recurrence is >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 other evidence of bleeding from oesophageal varices or other
- •conditions consistent with decompensated liver disease.
- •History or other 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 the 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
- •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 a value of 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)
- •No other routine vaccination, nor booster vaccination, within 14 days before
- •any treatment day or 14 days after a treatment day.
- •Participation in an investigational drug, vaccine or device study* within 3
- •months prior to screening or more than 4 times a year.*Excluding studies
- •comprising donation of body materials for biobanking or research only.
- 另有 2 项未显示
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