Primary immunization of healthy elderly subjects (60 to 69 and more than or equal to 70 years) against zoster
Conditions
Interventions
Product Name: Recombinant VZV glycoprotein gE antigen adjuvanted with AS01B
Product Code: gE/AS01B vaccine
Pharmaceutical Form: Suspension for injection
Current Sponsor code: gE
Concentration unit: µg
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1/ 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 2/ A male or female aged 60 years or older at the time of the first vaccination 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/ Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first injection with study vaccine, or planned use during the study period 2/ Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccination, including corticosteroids, except inhaled and topical steroids are allowed. 3/ Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks of the first study vaccine injection, with the exception of the influenza vaccine, which can be administered 1 week preceding or 1 month after the first study vaccine injection 4/ Previous administration of a vaccine containing MPL and/or QS21 5/ Previous vaccination against HZ 6/ History of herpes zoster (Shingles) 7/ Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required) 8/ History of allergic disease or reactions likely to be exacerbated by any component of the vaccine 9/ 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 diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., Oral temperature <37.5°C (99.5°F)/Axillary temperature <37.5°C (99.5°F) 10/ Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by subject’s medical history or physical examination as assessed by the investigator 11/ 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 12/ History of or current drug and/or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to compare the CD4 T cell response to gE of gE/AS01B study vaccines at Month 3 in healthy elderly subjects of more than or equal to 70 years of age (YOA).;Secondary Objective: 1/ Compare the CD4 T cell response to gE between 100 mg gE/AS01B vaccine and 100 mg gE/saline vaccine at Month 3 in healthy elderly subjects > or = 70 YOA 2/ Compare the serological response to gE and VZV of gE/AS01B study vaccines at Month 3 in healthy elderly subjects > or = 70 YOA 3/ Evaluate the CD4/CD8 T cell response to gE after one and two injections of study vaccine formulations in healthy elderly subjects (60 to 69 YOA and > or = 70 YOA) 4/ Evaluate the serological response after one and two injections of study vaccine formulations in healthy elderly subjects (60 to 69 YOA and > or = 70 YOA) 5/ Evaluate the persistence of the cell-mediated and serological responses of study vaccine formulations at months 12, 24 and 36 6/ Evaluate the safety and reactogenicity of all study vaccine formulations in healthy elderly subjects (60 to 69 YOA and > or = 70 YOA) 7/ Evaluate the incidence of clinically diagnosed herpes zoster (HZ). ;Primary end point(s): The primary endpoint is frequencies of CD4 T cells with at least two antigen-specific cytokines (IFN-g, IL-2, TNF-a, CD40L) to gE as determined by intracellular cytokine staining (ICS) one month after the second vaccination (Month 3) in gE/AS01B study vaccine groups of more than or equal to 70 YOA subjects. | — |
Countries
Czech Republic, Germany, Netherlands, Sweden
Outcome results
None listed