A first-time-in human (FTIH), Phase I/II, randomized, multi-centric, single-blind, controlled dose-escalation study to evaluate the reactogenicity, safety, immunogenicity and efficacy of GSK Biologicals’ HBV viral vector vaccines given in a prime-boost schedule with sequential or co-administration of adjuvanted proteins therapeutic vaccine (GSK3528869A) in chronic Hepatitis B patients (18-65 years old) well controlled under nucleo(s)tides analogues (NA) therapy. - TH HBV VV-001

GlaxoSmithKline Biologicals0 个研究点目标入组 158 人2018年4月17日

适应症Chronic hepatitis B MedDRA version: 20.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Virus Diseases [C02]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Chronic hepatitis B
发起方: GlaxoSmithKline Biologicals
入组人数: 158
状态: 进行中（未招募）
最后更新: 2年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2018年4月17日

结束日期

待定

最后更新

2年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

GlaxoSmithKline Biologicals

入排标准

入选标准

•Patients who, in the opinion of the investigator, can and will comply with the requirements of the protocol
•Written informed consent obtained from the patient prior to performing any study specific procedure
•A male or female between, and including, 18 and 65 years of age at the time of the first vaccination
•Female patients of non\-childbearing potential may be enrolled in the study. Non\-childbearing potential is defined as hysterectomy, bilateral ovariectomy or post\-menopause
•Female patients of childbearing potential may be enrolled in the study if the patient:
•\-has practiced adequate contraception for 30 days prior to vaccination, and
•\-has a negative pregnancy test at Screening, and
•\-has agreed to continue adequate contraception from Screening until 12 weeks after completion of the vaccination series
•Male patients:
•\-with documented bilateral vasectomy and resultant azoospermia, bilateral orchiectomy or azoospermia, or

排除标准

•Use of any investigational or non\-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines or planned use during the study period
•Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe
•Chronic administration of immunosuppressants or other immune\-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone \= 10 mg/day or equivalent. Inhaled and topical steroids are allowed
•Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccines or planned administration during the study period
•Use of systemic cytotoxic agents, chronic antiviral agents or Chinese herbal medicines which, in the opinion of the investigator, may have activity against HBV within the previous 6 months prior to randomization into this study. Antiviral treatment/prevention for influenza or herpes simplex virus is allowed
•Administration of adenovirus/adenovector\-based or MVA\-based vaccine within the last 12 months except for adenovirus/adenovector\-based COVID\-19 vaccines that could be administered up to 30 days prior to the first study vaccine dose (applicable for all patients except for the patients in France) OR Administration of adenovirus/adenovector\-based
•or MVA\-based vaccine within the last 12 months (applicable for the
•patients in France only).
•Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 14 days before each dose and ending 30 days after each dose of vaccines, with the exception of influenza vaccine that may be given at any time except within a 7\-day period before or after each vaccine dose and COVID\-19 vaccine that may be given at any time except within a 30\-day period before or after each vaccine dose apart from COVID\-19 mRNA based\-vaccines that may be administered any time except for the period of 14 days before and 30 days after each study vaccine dose. Note: If the type of COVID\-19 vaccine is unknown, the allowed interval of 30 days before or after each study vaccine dose should be followed
•Treatment with nephrotoxic drugs or competitors of renal excretion within 2 months prior to Screening or the expectation that patient will receive any of these during the course of the study. TAF/TDF given as NA therapy is allowed