Vaccination against herpes zoster (HZ) in adult HIV-infected subjects. MedDRA version: 14.1 Level: PT Classification code 10019974 Term: Herpes zoster System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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. =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the safety and reactogenicity of the gE/AS01B study vaccine in HIV-infected subjects, by ART (antiretroviral therapy) ART and CD4 count cohorts, and overall (ART/CD4/overall) •To estimate the gE-specific humoral and cellular immune responses (hum/cell imm resp) at Month 7 (one month post-final vaccination) in subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6) in comparison to subjects who received placebo (pl), in ART and non-ART cohorts presenting high CD4 counts at enrolment ;Secondary Objective: •To estimate the gE-specific hum/cell imm resp at Month 7 after 3 doses of gE/AS01B versus pl, by ART/CD4/overall •To estimate the VZV-specific hum/cell imm resp at Month 7 after 3 doses of gE/AS01B versus pl, by ART/CD4/overall •To estimate gE- and VZV-specific hum/cell imm resp after the 1st and 2nd vaccinations in comparison to after 3 doses in subjects who received gE/AS01B and in comparison to subjects who received pl, by ART/CD4/overall •To estimate gE- and VZV-specific hum/cell imm resp at Month 18 (12 months post-final vaccination) after 3 doses of gE/AS01B versus pl, by ART/CD4/overall •To evaluate the occurrence, duration and severity of HZ cases and complications from administration of the 1st dose of vaccine/placebo until end of the trial, by ART/CD4/overall •To evaluate the effect of the gE/AS01B on CD4 T cell count and HIV viral load (VL) versus pl at Months 1, 2, 3, 6, 7 and 18, by ART and CD4 count cohorts ;Primary end point(s): •Serious AEs: Occurrence and relationship to vaccination of all SAEs from Month 0 onwards until study end, in each cohort, and overall; Occurrence of SAEs related to study participation or to a concurrent GSK medication/vaccine during the entire study period in each cohort, and overall; Occurrence of any fatal SAEs during the entire study period in each cohort, and overall. •Occurrence of pre-defined AEs: Occurrence and relationship to vaccination of any new onset of autoimmune d | — |
Countries
Germany, United Kingdom
Outcome results
None listed