Overview

This trial is active, not recruiting.

Condition herpes zoster
Treatment herpes zoster vaccine gsk1437173a
Phase phase 3
Sponsor GlaxoSmithKline
Start date April 2016
End date August 2017
Trial size 73 participants
Trial identifier NCT02735915, 2015-004400-30, 204926

Summary

The purpose of this study is to evaluate the persistence of immune response to the HZ vaccine as well as safety up to 10 years after the first dose of initial vaccination course. This study will also assess immune responses after re-vaccination with 2 additional doses of the HZ/su administered at ten years after first dose of initial vaccination course from study Zoster-003 (NCT00434577).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Subjects will receive Herpes Zoster Vaccine GSK1437173A according to a 0, 2-month schedule.
herpes zoster vaccine gsk1437173a HZ/su
Intramuscular injection

Primary Outcomes

Measure
Antigen-specific antibody (Ab) concentrations.
time frame: At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Antigen-specific antibody (Ab) concentrations.
time frame: At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4 T-cells.
time frame: At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4 T-cells.
time frame: At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).

Secondary Outcomes

Measure
Antigen-specific antibody (Ab) concentrations.
time frame: At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4 T-cells.
time frame: At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Occurrence of all serious adverse events (SAEs) related to study participation or to a concurrent GSK medication/vaccine (including HZ/su administered during the Zoster-003 (NCT00434577) study).
time frame: Between Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Antigen-specific antibody (Ab) concentrations post re-vaccination.
time frame: At 1 month post each vaccination dose, and at 12 months after the last vaccination dose in current study (corresponding to 121, 123 and 134 months post first dose of initial vaccination course in study Zoster-003 (NCT00434577)).
Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4 T- cells.
time frame: At 1 month post each vaccination dose, and at 12 months after the last vaccination dose in current study (corresponding to 121, 123 and 134 months post first dose of initial vaccination course in study Zoster-003 (NCT00434577)).
Occurrence and intensity of each solicited local and general symptom in all subjects.
time frame: Within 7 days (Days 0-6) after each vaccination in the current study.
Occurrence, intensity and relationship to vaccination of unsolicited AEs according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects.
time frame: During 30 days (Days 0-29) after each vaccination in the current study.
Occurrence and relationship to vaccination of all SAEs.
time frame: From Dose 1 of re-vaccination until study end at 14 months after the last dose of the vaccination in the current study.
Occurrence of any fatal SAEs.
time frame: From Dose 1 of re-vaccination until study end at 14 months after the last dose of the vaccination in the current study.
Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs).
time frame: From Dose 1 of re-vaccination until study end at 14 months after the last dose of the vaccination in the current study.

Eligibility Criteria

Male or female participants at least 68 years old.

Inclusion Criteria: - Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, ability to have scheduled contacts to allow evaluation during the study). Or subjects with a caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, vaccination visits, availability for follow-up contacts). - Written informed consent obtained from the subject prior to performance of any study specific procedure. - Previous participation in study ZOSTER-003 (NCT00434577), in group 50 µg gE / AS01B, and who completed the vaccination course (2 doses of HZ/su) in study ZOSTER-003 (NCT00434577). - Subjects are expected to enter the study (or complete Visit 1) as of the time they turn 108 months after first vaccination of previous vaccination course with HZ/su and not later than 111 months. Exclusion Criteria: - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the first study visit (Day -29 to Day 0), or planned use during the study period. - Use or anticipated use of immunosuppressants or immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids (>14 consecutive days of prednisone at a dose of ≥20 mg/day [or equivalent]), long-acting immune-modifying agents (e.g., infliximab) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). - Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection). - Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine* within 8 days prior to or within 14 days after either dose of study vaccine. E.g., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines and pneumococcal conjugate vaccines. - Previous vaccination against HZ since initial vaccination in Zoster-003. - Administration of immunoglobulins and/or any blood products during the period starting 3 months before the study start, or planned administration during the study period. - History of previous HZ.

Additional Information

Official title Long Term Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine 1437173A and Assessment of Re-vaccination With 2 Additional Doses, in Healthy Subjects Aged 60 Years of Age and Older
Description In this LTFU study (ZOSTER-060), subjects who received 2 doses of HZ/su in the earlier Zoster-003 (NCT00434577) study will be followed up at Month 108/Year 9 and Month 120/Year 10 post first dose of vaccine for safety and immunogenicity (humoral and cellular). In order to assess the effect of re-vaccination with 2 additional doses of HZ/su vaccine, all the subjects will receive 2 additional doses of the HZ/su vaccine, on a 0, 2-month schedule at ten years after the initial vaccination course in study Zoster-003 (NCT00434577), and will be followed for reactogenicity, safety and humoral and cellular immunogenicity (including persistence). In alignment with the previous persistence timepoints, this study has no control group.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.