Clinical trial NCT02581410: Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Least 5 Years Earlier
Official title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Least 5 Years Earlier
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Keywords: Zostavax®
≥ 65 years of age
Herpes Zoster
Shingles
Immunogenicity
Safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-10-21
Enrollment: 430
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults ≥ 65 years of age with and without Zostavax® vaccination at least 5 years earlier.

Detailed description: The study will evaluate two parallel groups of 200 adults ≥ 65 YOA; one group (Prev-Zvax) with a previous Zostavax® vaccination at least 5 years earlier, versus the other group without a previous Zostavax® vaccination (No prev-Zvax). The goal of this study is to generate immunogenicity, safety and reactogenicity data for the respective vaccines.

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 ≥ 65 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject prior to performing any study specific procedure.

For the No prev-Zvax group only:

• No previous vaccination with Zostavax.

For the Prev-Zvax group only:

• Previous vaccination with Zostavax ≥ 5 calendar years earlier.

* Documentation indicating the date of previous Zostavax vaccination will be required.

Exclusion Criteria:

* Previous vaccination with Zostavax \< 5 calendar years earlier and/or anyone that ever received more than a single dose of Zostavax.
* Previous vaccination against VZV, administration of HZ/su vaccine or any other investigational or non-registered HZ vaccine (except Zostavax for the Prev-Zvax group).
* Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as \> 14 consecutive days) of immunosuppressants or other immune-modifying drugs in the period starting 6 months prior to the first dose of vaccine. (For corticosteroids, a prednisone dose of \< 20 mg/day, or equivalent, is allowed.) Inhaled, topical and intra-articular corticosteroids are allowed.
* Administration of long-acting immune-modifying drugs (e.g., infliximab) in the period starting 6 months prior to the first vaccine dose or expected administration at any time during the study period.
* 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 in the period starting 8 days prior to and ending 14 days after either dose of study vaccine.
* Current participation in or planned concurrent participation 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.
* Planned administration of an HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine during the entire study.
* History of HZ or any suspected HZ between the screening visit and Visit 1.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/product.
* 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) by oral route, axillary or tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The recommended route for recording temperature in this study will be oral.
  * Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
* Administration of immunoglobulins and/or any blood products in the period starting 3 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.
* Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe.

Primary outcomes:
measure: Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations
timeFrame: One month after dose 2, at Month 3
measure: Number of Subjects With Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) period after each dose.
measure: Number of Days With Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) period after each dose.
measure: Number of Subjects With Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) period after each dose.
measure: Number of Days With Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) period after each dose.
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs)
timeFrame: During the 30-day (Days 0-29) period after each dose.
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs)
timeFrame: From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)
measure: Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
timeFrame: From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)
Secondary outcomes:
measure: Anti-gE Ab Concentrations
timeFrame: At Months 0, 1, 3 and 14.
measure: Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells
timeFrame: At Months 0, 1, 3 and 14.
measure: Number of Subjects With Any and Related SAEs
timeFrame: From 30 days post last vaccination (Month 3) until study end at Month 14
measure: Number of Subjects With Any pIMDs
timeFrame: From 30 days post last vaccination (Month 3) until study end at Month 14
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: GSK Investigational Site
state: Alabama
city: Daly City
country: United States
facility: GSK Investigational Site
state: California
city: Los Gatos
country: United States
facility: GSK Investigational Site
state: California
city: Oakland
country: United States
facility: GSK Investigational Site
state: California
city: Roseville
country: United States
facility: GSK Investigational Site
state: California
city: Santa Rosa
country: United States
facility: GSK Investigational Site
state: California
city: Boise
country: United States
facility: GSK Investigational Site
state: Idaho
city: Lenexa
country: United States
facility: GSK Investigational Site
state: Kansas
city: Newton
country: United States
facility: GSK Investigational Site
state: Kansas
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Auburn
country: United States
facility: GSK Investigational Site
state: Maine
city: Columbia
country: United States
facility: GSK Investigational Site
state: Maryland
city: Elkridge
country: United States
facility: GSK Investigational Site
state: Maryland
city: Marlborough
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Binghamton
country: United States
facility: GSK Investigational Site
state: New York
city: Endwell
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Corvallis
country: United States
facility: GSK Investigational Site
state: Oregon
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Uniontown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Layton
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: South Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Newport News
country: United States
facility: GSK Investigational Site
state: Virginia
city: Eau Claire
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Marshfield
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Dagnew AF, Klein NP, Herve C, Kalema G, Di Paolo E, Peterson J, Salaun B, Schuind A. The Adjuvanted Recombinant Zoster Vaccine in Adults Aged >/=65 Years Previously Vaccinated With a Live-Attenuated Herpes Zoster Vaccine. J Infect Dis. 2021 Oct 13;224(7):1139-1146. doi: 10.1093/infdis/jiaa083.
citation: Grupping K, Campora L, Douha M, Heineman TC, Klein NP, Lal H, Peterson J, Vastiau I, Oostvogels L. Immunogenicity and Safety of the HZ/su Adjuvanted Herpes Zoster Subunit Vaccine in Adults Previously Vaccinated With a Live Attenuated Herpes Zoster Vaccine. J Infect Dis. 2017 Dec 12;216(11):1343-1351. doi: 10.1093/infdis/jix482.