Clinical trial NCT01751165: Safety and Immunogenicity of Different Dosing Schedules of GlaxoSmithkline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine in Adults 50 Years of Age or Older
Official title: Open-label Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Keywords: ≥ 50 years of age
Herpes zoster
Safety
Immunogenicity
Adults
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-12-17
Enrollment: 354
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals' HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged 50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer than two months is not known.

Detailed description: Subjects in each group will be stratified by age with a minimum of 35 subjects in each stratum (50-59 years of age (YOA) stratum, 60-69 YOA stratum and ≥ 70 YOA stratum).

Eligibility criteria: Inclusion Criteria:

* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* A male or female aged 50 years or older at the time of the first vaccination.
* Written informed consent obtained from the subject.
* Female subjects of non-childbearing potential may be enrolled in the study.

  * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:

  * has practiced adequate contraception for 30 days prior to vaccination, and
  * has a negative pregnancy test on the day of vaccination, and
  * has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, a prednisone dose of \< 20 mg/day, or equivalent, is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
* Administration or planned administration of a live vaccine in the period starting 30 days before and ending 30 days after either dose of study vaccine.
* Administration or planned administration of a non-replicating vaccine within eight days prior to or within 14 days after either dose of study vaccine.
* Administration of long-acting immune-modifying drugs (e.g. infliximab) within six months prior to the first vaccine dose or expected administration at any time during the study period.
* Previous vaccination against varicella or HZ (either registered product or participation in a previous vaccine study).
* Planned administration during the study of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
* History of HZ.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g. malignancy, human immunodeficiency virus \[HIV\] infection) or immunosuppressive/cytotoxic therapy (e.g. medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
* Acute disease and/or fever at the time of enrolment.

  * Fever is defined as temperature ≥ 37.5°C (99.5°F) for oral, axillary or tympanic route, or ≥ 38.0°C (100.4°F) for rectal route. The preferred route for recording temperature in this study will be oral.
  * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study.
* Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
* Pregnant or lactating female.
* Female planning to become pregnant during the entire treatment period and for two months after completion of the vaccination series, or planning to discontinue contraceptive precautions (if of childbearing potential).

Primary outcomes:
measure: Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA).
timeFrame: At one month (M1) after Dose 2
measure: Concentrations of Antibodies Against Anti-gE as Determined by ELISA.
timeFrame: At one month (M1) after Dose 2
Secondary outcomes:
measure: Concentrations of Antibodies Against Anti-gE as Determined by ELISA.
timeFrame: Prior (PRE) to vaccination and twelve (M12) post Dose 2
measure: Number of Subjects With Solicited Local Symptoms.
timeFrame: During the 7 day period (Days 0-6) following each dose (D)
measure: Number of Subjects With Solicited General Symptoms.
timeFrame: During the 7 day period (Days 0-6) following each dose (D)
measure: Number of Subjects With Unsolicited Adverse Events (AEs).
timeFrame: During the 30 Days (Day 0-29) following vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs).
timeFrame: From first vaccination up to one month (30 Days) post last vaccination
measure: Number of Subjects With SAE(s).
timeFrame: Starting from 30 Days post last vaccine administration up to study end at Month 24
measure: Number of Days With Solicited Local Symptoms.
timeFrame: During the 7 Days (Day 0-6) following vaccination
measure: Number of Days With Solicited General Symptoms.
timeFrame: During the 7 Days (Day 0-6) following vaccination
measure: Number of Subjects With Potential Immune-mediated Diseases (pIMDs).
timeFrame: From Dose 1 up to one month (30 days) following the last vaccine dose administration (Dose 2)
measure: Number of Subjects With pIMDs.
timeFrame: From one month (30 Days) following the last vaccine administration up to study end at Month 24
Other outcomes:
Locations:
city: Spring Valley
country: United States
facility: GSK Investigational Site
state: California
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Uniontown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Tartu
country: Estonia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Lal H, Poder A, Campora L, Geeraerts B, Oostvogels L, Vanden Abeele C, Heineman TC. Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: Results of a phase III, randomized, open-label, multicenter study. Vaccine. 2018 Jan 2;36(1):148-154. doi: 10.1016/j.vaccine.2017.11.019. Epub 2017 Nov 22.