An open, phase II long term extension study to evaluate the immune responses to and safety of GSK Biologicals’ candidate herpes zoster vaccine, (gE/AS01B), at Months 48, 60 and 72 post-vaccination in healthy subjects aged 60 years of age and older. - ZOSTER-024

• Register: EUCTR
• Last refreshed on: 17 October 2016
• Main ID: EUCTR2010-022248-19-NL
• Date of registration: 27/01/2011
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: An open, phase II long term extension study to evaluate the immune responses to and safety of GSK Biologicals’ candidate herpes zoster vaccine, (gE/AS01B), at Months 48, 60 and 72 post-vaccination in healthy subjects aged 60 years of age and older. - ZOSTER-024
• Scientific title: An open, phase II long term extension study to evaluate the immune responses to and safety of GSK Biologicals’ candidate herpes zoster vaccine, (gE/AS01B), at Months 48, 60 and 72 post-vaccination in healthy subjects aged 60 years of age and older. - ZOSTER-024
• Date of first enrolment: 08/03/2011
• Target sample size: 166
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022248-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Czech Republic, Germany, Netherlands, Sweden

Key inclusion & exclusion 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:
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;



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Product Name: gE recombinant protein formulated in AS01B Adjuvant System
Product Code: gE/AS01B
Pharmaceutical Form: Powder and solvent for suspension for injection
Current Sponsor code: gE
Other descriptive name: gE recombinant protein
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

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;

Secondary ID(s)

114825

2010-022248-19-SE