Clinical trial NCT01295320: Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects
Official title: Long Term Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpes Zoster
Keywords: Herpes Zoster
vaccine
safety
immunogenicity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-02-14
Enrollment: 129
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The subjects included in this study are subjects that participated in study NCT00434577. These subjects were vaccinated with the candidate Herpes Zoster (HZ) vaccine at Month 0 and Month 2 and were then followed at Month 12, Month 24 and Month 36 (study NCT00434577) for safety and immunogenicity.

This long term follow up study (ZOSTER-024 \[114825\]) will evaluate immune responses to and safety of the previously administered candidate HZ vaccine at Months 48, 60 and 72.

The study visits will be scheduled at approximately one year intervals after the first visit in ZOSTER-024. Blood samples for the evaluation of cellular and humoral immunity will be taken from all subjects at each visit. Information on safety and the occurrence of HZ will also be collected during these visits.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol
* Previous participation in study NCT00434577 as a member of the intermediate dose active vaccine group
* Written informed consent obtained from the subject

Exclusion Criteria:

* Having participated in another study at any time after NCT00434577 study end in which the subject was exposed to an investigational or non-investigational product 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
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first blood draw
* Having received a vaccine containing some vaccine components, any time after study end of study NCT00434577
* Having received a vaccine against HZ any time after study end of study NCT00434577
* Subject who did not receive a complete vaccination course of 2 doses of the intermediate dose active vaccine in study NCT00434577

Primary outcomes:
measure: Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
timeFrame: Month 48
measure: Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
timeFrame: Month 60
measure: Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
timeFrame: Month 72
measure: Antigen-specific Antibody (Ab) Concentrations
timeFrame: Month 48
measure: Antigen-specific Antibody (Ab) Concentrations
timeFrame: Month 60
measure: Antigen-specific Antibody (Ab) Concentrations
timeFrame: Month 72
Secondary outcomes:
measure: Number of Subjects With Any Serious Adverse Events (SAEs) Related to the Study Participation
timeFrame: Month 48 to Month 72
measure: Number of Subjects With Any SAEs Related to Previous Vaccination and Not Already Documented
timeFrame: Month 0 to Month 72
measure: Number of Subjects With Any Fatal SAEs
timeFrame: Month 48 to Month 72
measure: Number of Subjects With Any Suspected Cases of HZ Episodes
timeFrame: Month 48 to Month 72
measure: Number of Subjects With Any Suspected Cases of HZ Episodes Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented
timeFrame: Month 48 to Month 72
measure: Number of Subjects and Relationship to Vaccination of Any Potential Immune Mediated Diseases (pIMDs) Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented
timeFrame: Month 48 to Month 72
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: GSK Investigational Site
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Eskilstuna
country: Sweden
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: