Evaluation of persistence of immune responses following immunisation of healthy elderly subjects (60-69 and =70 years) against Herpes Zoster (HZ) MedDRA version: 12.1 Level: LLT Classification code 10019974 Term: Herpes zoster
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g. return for follow-up visits) 2)Previous participation in study ZOSTER-003 as a member of the 50µg gE/AS01B vaccine group; 3)Written informed consent obtained from the subject. 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: 1)Having participated in another study at any time after ZOSTER-003 study end in which the subject was exposed to an investigational or non-investigational product (pharmaceutical product or device) or; 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); 2)Administration of immunoglobulins and/or any blood products within the 3 months preceding the first blood draw; 3)Having received a vaccine containing 3-O-desacyl-4’-Monophosphoryl Lipid A (MPL) and/or Quillaja saponaria Molina, fraction 21 (QS21), any time after ZOSTER-003 study end; 4)Having received a vaccine against HZ any time after ZOSTER-003 study end; 5)Subject who did not receive a complete vaccination course of 2 doses of 50µg gE/AS01B in study ZOSTER-003;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate cell-mediated and humoral immune responses of the study vaccine in healthy elderly adults overall and within each age cohort (60-69 years of age [YOA] and = 70 YOA) at Months 48, 60 and 72.;Secondary Objective: 1)To evaluate the safety of the study vaccine in healthy elderly subjects (60-69 YOA and = 70 YOA) at Months 48, 60 and 72. 2)To collect basic clinical data on suspected cases of HZ;Primary end point(s): 1)Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4 T cells at Months 48, 60 and 72 : Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-gamma) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-alpha) and/or CD40 Ligand (CD40L) secretion/expression to gE and VZV as determined by Intracellular Cytokine Staining (ICS) at Months 48, 60 and 72 for all subjects 2)Antigen-specific Antibody (Ab) concentrations at Months 48, 60 and 72:Anti-gE and anti-VZV Ab concentrations as determined by ELISA at Months 48, 60 and 72 for all subjects; | — |
Countries
Czech Republic, Germany, Netherlands, Sweden
Outcome results
None listed