Primary immunisation of subjects aged 50 years or older against herpes zoster (HZ). The study population includes healthy volunteer males and females in the age ranges: 50-59 years of age (YOA), 60-69 YOA, and more than 70 YOA.
Conditions
Interventions
Product Name: gE recombinant protein formulated in AS01B adjuvant
Product Code: gE-AS01B
Pharmaceutical Form: Powder and solvent for suspension for injection
Current Sponsor code: gE
Other descriptive
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • A male or female 50 years of age or above at the time of the first vaccination; • Written informed consent obtained from the subject; • 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) should be enrolled in the study; • If the subject is female, she must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series. 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
Exclusion criteria
Exclusion criteria: • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period; • Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, more than 0.5 mg/kg/day. Inhaled and topical steroids are allowed); • Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before the first study vaccination (2 weeks in the case of inactivated influenza vaccines or other non-replicating immunisation products [e.g., tetanus and reduced dose diphtheria toxoid (dT) vaccine, pneumococcal vaccine, hepatitis A vaccine, hepatitis B vaccine]), or scheduled within 30 days after study vaccination; • Previous vaccination against HZ; • Previous vaccination against varicella; • History of HZ; • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine; • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, HIV-infection) 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 the 3 months preceding the first injection of study vaccine or planned administration during the study period; • Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral, tympanic or axillary temperature < 37.5°C/99.5°F); • Any other condition (e.g., extensive psoriasis, chronic pain syndrome, cognitive impairment, severe hearing loss) that, in the opinion of the investigator, might interfere with the evaluations required by the study; • History of or current drug and/or alcohol abuse; • Pregnant or lactating female; • Female planning to become pregnant or planning to discontinue contraceptive precautions if of childbearing potential).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare gE and VZV-specific CD4 T cell-mediated immune (CMI) and humoral immune responses to study vaccines (gE/AS01B, gE/AS01E, and gE/Saline) at Month 3 (one month following vaccinations at Months 0 and 2) in subjects = 50 YOA (overall study population).;Secondary Objective: • To compare gE and VZV-specific CMI and humoral immune responses to study vaccines at Month 3 (1 month following vaccinations at Months 0 and 2) in subjects in each of the age ranges (50-59 YOA, 60-69 YOA and = 70 YOA) and overall (CD8 T cell-mediated response); • To evaluate the safety and reactogenicity of study vaccines and placebo after each vaccination overall and in each age range; • To collect preliminary data on suspected cases of HZ in all treatment groups. Exploratory objectives: • To compare gE and VZV-specific CMI and humoral immunity between US and EU subjects at Month 0 (pre-vaccination) and at Month 3 (1 month following vaccinations at Months 0 and 2) in all treatment groups, overall and in each age range; • To evaluate anti-VZV neutralising antibody (Ab) titers in a subset of subjects at Month 0 (pre-vaccination) and at Month 3 (1 month following vaccinations at Months 0 and 2) in all study groups receiving gE-containing vaccines, overall and in each age range.;Primary end point(s): • Frequencies of CD4 T cells specific for gE and VZV antigens, as determined by in vitro intracellular cytokine staining (ICS), expressing at least 2 cytokines (from among IFN-g, IL-2, TNF-a and CD40L) 1 month after the second vaccination (Month 3); • Anti-gE and anti-VZV Ab concentrations as determined by enzyme-linked immunosorbent assay (ELISA) 1 month after the second vaccination (Month 3). | — |
Countries
Czech Republic
Outcome results
None listed