Clinical trial NCT01165177: Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older
Official title: Efficacy, Safety, and Immunogenicity Study 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: subjects 50 years and older
vaccine
immunogenicity
efficacy
Herpes Zoster
safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-07-19
Enrollment: 16165
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 observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 50 years.

Two studies \[ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)\] are being conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. The protocol posting of study ZOSTER-022 also deals with the outcome measures related to the pooled analysis.

Detailed description: This protocol summary has been updated following Protocol Amendment 4 changes to study objectives and endpoints and the analyses of the objectives in 2 steps.

Step 1 will include analyses of the following objectives of ZOSTER-006 (NCT01165177): all HZ VE objectives and all reactogenicity/safety and immunogenicity objectives. At step 2, all objectives of study ZOSTER-006 (NCT01165177) will be analyzed. Objectives already analyzed at step 1 will be re-analyzed (confirmatory descriptive in case of inferential analysis at step 1 or descriptive analysis otherwise). At step 2, pooled analyses of studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) are planned; overall PHN VE in subjects ≥ 70 YOA, and other pre-specified endpoints will be analyzed.

Eligibility criteria: Inclusion Criteria:

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

For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.

OR 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 urine pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 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;
* 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;
* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;
* History of HZ;
* Previous vaccination against varicella or HZ;
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation;
* Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study;
* Receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period;
* Administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine;
* Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;
* Acute disease and/or fever at the time of enrollment;
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Pregnant or lactating female;
* Female planning to become pregnant or planning to discontinue contraceptive precautions.

Primary outcomes:
measure: Number of Subjects With Confirmed Herpes Zoster (HZ) Cases
timeFrame: During the entire study period (3 to 5 year period following Day 0)
Secondary outcomes:
measure: Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN)
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With Confirmed HZ Episode Related Mortality
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With HZ Related Complications
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With Confirmed HZ Episode Related Hospitalizations
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Days With Severe 'Worst' HZ-associated Pain.
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With HZ Related Complications, by Complication Type
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Distribution of Pain Medication Associated With HZ
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Days of Pain Medication Associated With HZ
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: Within the 7-day (Days 0-6) post-vaccination period
measure: Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited)
timeFrame: Within the 7-day (Days 0-6) post-vaccination period
measure: Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With AEs With Any and Related Medically Attended Visit
timeFrame: From Month 0 to Month 8 post-vaccination
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: Within 30 days (Days 0 - 29) after each vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: Within the 30-day (Days 0-29) post-vaccination period, up to Month 14 and up to study end (3 to 5 year period following Day 0)
measure: Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With Fatal SAEs
timeFrame: During the entire study period (3 to 5 years following day 0)
Other outcomes:
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country: Sweden
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan
country: Taiwan
facility: GSK Investigational Site
city: Buckshaw Village, Chorley
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Buckshaw Village, Chorley
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Atherstone
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
city: Atherstone
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
city: Bradford on Avon
country: United Kingdom
facility: GSK Investigational Site
state: Wiltshire
city: Bradford on Avon
country: United Kingdom
facility: GSK Investigational Site
state: Wiltshire
city: Bangor
country: United Kingdom
facility: GSK Investigational Site
city: Bangor
country: United Kingdom
facility: GSK Investigational Site
city: Belfast
country: United Kingdom
facility: GSK Investigational Site
city: Belfast
country: United Kingdom
facility: GSK Investigational Site
city: Broughshane
country: United Kingdom
facility: GSK Investigational Site
city: Broughshane
country: United Kingdom
facility: GSK Investigational Site
city: Ledbury
country: United Kingdom
facility: GSK Investigational Site
city: Ledbury
country: United Kingdom
facility: GSK Investigational Site
city: Newtonabbey
country: United Kingdom
facility: GSK Investigational Site
city: Newtonabbey
country: United Kingdom
facility: GSK Investigational Site
city: Waterloo, Liverpool
country: United Kingdom
facility: GSK Investigational Site
city: Waterloo, Liverpool
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
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citation: Kim JH, Diaz-Decaro J, Jiang N, Hwang SJ, Choo EJ, Co M, Hastie A, Hui DSC, Irimajiri J, Lee J, Leung EM, Tang H, Tsuru T, Watson P, Wu Z, Yu CJ, Yuan Y, Zahaf T, Cunningham AL, Schuind A. The adjuvanted recombinant zoster vaccine is efficacious and safe in Asian adults >/= 50 years of age: a sub-cohort analysis of the ZOE-50 and ZOE-70 randomized trials. Hum Vaccin Immunother. 2021 Jul 3;17(7):2050-2057. doi: 10.1080/21645515.2020.1859321. Epub 2021 Feb 19.
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citation: Colindres R, Wascotte V, Brecx A, Clarke C, Herve C, Kim JH, Levin MJ, Oostvogels L, Zahaf T, Schuind A, Cunningham AL. Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials. Hum Vaccin Immunother. 2020 Nov 1;16(11):2628-2633. doi: 10.1080/21645515.2020.1741312. Epub 2020 Apr 29.
citation: Willer DO, Oostvogels L, Cunningham AL, Gervais P, Gorfinkel I, Hyung Kim J, Talarico C, Wascotte V, Zahaf T, Colindres R, Schuind A; ZOE 50/70 study groups. Efficacy of the adjuvanted recombinant zoster vaccine (RZV) by sex, geographic region, and geographic ancestry/ethnicity: A post-hoc analysis of the ZOE-50 and ZOE-70 randomized trials. Vaccine. 2019 Oct 8;37(43):6262-6267. doi: 10.1016/j.vaccine.2019.09.028. Epub 2019 Sep 16.
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citation: Curran D, Oostvogels L, Heineman T, Matthews S, McElhaney J, McNeil S, Diez-Domingo J, Lal H, Andrews C, Athan E, Berglund J, Campora L, de Looze F, Korhonen T, Leung E, Levin M, Volpi A, Johnson RW; ZOE-50/70 Study Group. Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older. J Gerontol A Biol Sci Med Sci. 2019 Jul 12;74(8):1231-1238. doi: 10.1093/gerona/gly150.