EUCTR2009-017809-11-DE进行中（未招募）不适用
A phase I/IIa randomized, observer-blind, placebo-controlled, multicenter study to evaluate the safety and immunogenicity of the GSK Biologicals’ herpes zoster vaccine, gE/AS01B in comparison to placebo when administered as 3 doses to adult HIV-infected subjects. - ZOSTER-015
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, etc.);
- •Male and female subjects at least 18 years old at the time of vaccination;
- •Subjects born before 1985 and not from a tropical region. Subjects born in 1985 or later and subjects born before 1985 in tropical regions must have a history of VZV infection or serological evidence of prior VZV infection;
- •Written informed consent obtained from the subject;
- •Female subjects of non-childbearing potential may be enrolled in the study;
- •Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause,OR
- •Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
- •Known to be HIV-1 infected, diagnosed at least 1 year prior to enrolment;
- •For the ART High CD4 and ART Low CD4 cohorts:Stable on ART for at least one year (i.e. no change in therapy due to virologic or immunologic failure); CD4 T cell count = 50 cells /mm3 at screening; Undetectable VL (i.e. < 40 copies/mL, based on the cut-off of the HIV VL test used) at screening;
- •For the non-ART High CD4 cohort:ART-naïve subjects who have never received anti-retroviral therapy after HIV diagnosis (except for pregnant women receiving ART temporarily to prevent mother –to-child HIV transmission), and for whom commencement of ART is not expected based on current assessment within next seven months; HIV viral load (VL) 1000 -100 000 copies/mL at screening; CD4 T cell count = 500 cells/mm3 at screening.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period;
- •Vaccination against varicella or HZ within the previous 12 months;
- •Occurrence of a varicella or HZ episode within the previous 12 months;
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation (such as materials that may possibly contain latex -gloves, syringes, etc). Please note, the vaccine and vials in this study do not contain latex;
- •Has currently an AIDS defining condition. Reference is made to Appendix A of the ‘Revised surveillance case definitions for HIV infection among adults, adolescents and children aged <18 Months and for HIV infection and AIDS among children aged 18 Months to < 13 years - United States, 2008’[CDC, 2008]);
- •Opportunistic infection (other than oral thrush) or AIDS-associated malignancy in the previous year;
- •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease other than HIV infection (e.g., malignancy) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders)
- •Administration of immunoglobulins, and/or any blood products within 90 days preceding the first dose of study vaccine/placebo or planned administration during the study period;
- •Chronic administration (defined as more than 15 consecutive days) of immunosuppressive or other immune-modifying drugs within 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone < 20 mg/day, or equivalent., is allowed. Inhaled and topical steroids are allowed;
- •Administration and/or planned administration of a vaccine not foreseen by the study protocol within 30 days before dose 1, dose 2 and/or 3 of vaccine and/or within 30 days after any dose. However, licensed non-replicating vaccines (i.e., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines, with or without adjuvant) may be administered up to 8 days prior to dose 1, 2 and/or 3, and/or at least 14 days after any dose of study vaccine;
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device);
- •Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). At the investigator’s discretion, all vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade fevers, i.e., oral/tympanic on oral setting/axillary temperature < 37.5°C (99.5°F) or < 38°C (100.4°F) on rectal setting. The preferred route for recording temperature in this study will be oral;
- •Any contraindication to receiving intramuscular injections;
- •Any condition or illness which might interfere with the evaluation of the safety or immunogenicity of the vaccine;
- •Active hepatitis B (HBV) infection or active hepatitis C (HCV) infection;
- •A prospective subject must be evaluated by lab tests (HBsAg, anti-HCV antibody (Ab) and/or HCV RNA) prior to enrolment unless inactive status of infection is known, i
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