Clinical trial NCT02735915: Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine at 9 and 10 Years After Vaccine Administration and Assessment of Re-vaccination With 2 Additional Doses at 10 Years After Initial Vaccination, in Healthy Subjects Aged 60 Years of Age(YOA) and Older
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Keywords: Immunogenicity
Safety
Long term follow-up
Adults
Herpes zoster
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-04-13
Enrollment: 70
Sex: ALL
Minimum age (years): 68
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations
timeFrame: At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
measure: Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations
timeFrame: At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
measure: Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells.
timeFrame: At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
measure: Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells.
timeFrame: At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Secondary outcomes:
measure: Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations by Each Age Category
timeFrame: At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
measure: Frequencies of Antigen-specific CD4 (2+) T-cells by Each Age Category
timeFrame: At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
measure: Number of Subjects With Any Serious Adverse Events (SAEs) Related to Study Participation or to a Concurrent GSK Medication/Vaccine (Including GSK1437173A Administered During the Zoster-003 [NCT00434577] Study).
timeFrame: Between Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
measure: Anti-gE Specific Antibody (Ab) Concentrations
timeFrame: At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134).
measure: Frequencies of Antigen-specific CD4 (2+) T-cells, Post Re-vaccination Course.
timeFrame: At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134).
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
timeFrame: Within 7 days (Days 0-6) after each vaccination and across doses, in the current study.
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: Within 7 days (Days 0-6) after each vaccination and across doses, in the current study.
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) According to the Medical Dictionary for Regulatory Activities (MedDRA) Classification in All Subjects.
timeFrame: Within 30 days (Days 0-29) after each vaccination in the current study.
measure: Number of Subjects With Any, Related and Fatal SAEs.
timeFrame: From Dose 1 of re-vaccination (Month 120) until study end (Month 134).
measure: Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs).
timeFrame: From Dose 1 of re-vaccination (Month 120) until study end (Month 134).
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: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Berlin
country: Germany
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:
citation: Schwarz TF, Volpe S, Catteau G, Chlibek R, David MP, Richardus JH, Lal H, Oostvogels L, Pauksens K, Ravault S, Rombo L, Sonder G, Smetana J, Heineman T, Bastidas A. Persistence of immune response to an adjuvanted varicella-zoster virus subunit vaccine for up to year nine in older adults. Hum Vaccin Immunother. 2018 Jun 3;14(6):1370-1377. doi: 10.1080/21645515.2018.1442162. Epub 2018 Mar 21.
citation: Hastie A, Catteau G, Enemuo A, Mrkvan T, Salaun B, Volpe S, Smetana J, Rombo L, Schwarz T, Pauksens K, Herve C, Bastidas A, Schuind A. Immunogenicity of the Adjuvanted Recombinant Zoster Vaccine: Persistence and Anamnestic Response to Additional Doses Administered 10 Years After Primary Vaccination. J Infect Dis. 2021 Dec 15;224(12):2025-2034. doi: 10.1093/infdis/jiaa300.