Clinical trial NCT03439657: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older
Official title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Keywords: HZ
Safety
Immunogenicity
Shingles
Adults
Prevenar 13
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-02-20
Enrollment: 913
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 immunogenicity and safety of GSK Biologicals' HZ vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two HZ/su doses are administered subsequent to Prevenar13.

Detailed description: Following the initial approval of the GlaxoSmithKline (GSK) Biologicals' HZ/su vaccine, the protocol was amended to indicate that the trademark is Shingrix. In addition, the term "candidate" vaccine has been replaced by "study" vaccine throughout the protocol.

Eligibility criteria: Inclusion Criteria:

* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject prior to performance of any study specific procedure.
* A male or female, aged ≥50 YOA at the time of the first vaccination with the study vaccine(s).
* Female subjects of non-childbearing potential may be enrolled in the study.
* 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 2 months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -30 to Day 1), or planned use during the study period.
* Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe.
* Use or anticipated use of immunosuppressants or other 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 or immunosuppressive/cytotoxic therapy. Inhaled, topical and intra-articular corticosteroids are allowed.
* Administration or planned administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration. This includes any type of vaccine such as (but not limited to) live, inactivated and subunit vaccines.
* 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 vaccine/product.
* Previous and/or planned administration of an HZ or VZV vaccine other than the study vaccine during the study period.
* History of HZ.
* History of documented pneumococcal infection within 5 previous years.
* Prior receipt of any pneumococcal vaccine or planned use during the study period, other than the study vaccines.
* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* Acute disease and/or fever at the time of enrollment.

  * Fever is defined as temperature ≥ 38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity.
  * Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
* Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions before 2 months after the last dose of study vaccine.
* Any person with cerebrospinal fluid (CSF) leaks, cochlear implants, chronic renal failure, nephrotic syndrome and functional or anatomic asplenia.
* Any medical condition that in the judgment of the investigator would prevent the subject from participating in the study.

Primary outcomes:
measure: Percentage of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group
timeFrame: One month post-dose 2 (Month 3)
measure: Anti-gE Antibody Concentrations
timeFrame: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).
measure: Anti-pneumococcal Antibody Titers
timeFrame: At one month post-dose 1 (Month 1)
measure: Adjusted Geometric Mean Concentrations (GMCs) for Anti-gE Antibody
timeFrame: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).
measure: Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies
timeFrame: At one month post-dose 1 (Month 1)
Secondary outcomes:
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose
timeFrame: Within 7 days (Day 1 - 7) after each vaccination
measure: Number of Days With Each Solicited Local Symptoms
timeFrame: Within 7 days (Day 1 - 7) after each vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: Within 7 days (Day 1 - 7) after each vaccination
measure: Number of Days With Solicited General Symptoms
timeFrame: Within 7 days (Day 1 - 7) after each vaccination
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE)
timeFrame: Within 30 days (Day 1 to 30) after each vaccination
measure: Number of Subjects With Any and Related Serious Adverse Events (SAE) From Day 1 to 30 Days Post Last Vaccination
timeFrame: From first vaccination at Day 1 up to 30 days post last vaccination
measure: Number of Subjects With Any and Related SAEs From 30 Days Post Last Vaccination up to Study End.
timeFrame: From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group)
measure: Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) From Day 1 to 30 Days Post Last Vaccination
timeFrame: From first vaccination at Day 1 up to 30 days post last vaccination.
measure: Number of Subjects With Any pIMDs From 30 Days Post Last Vaccination up to Study End.
timeFrame: From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group)
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose
timeFrame: Within 7 days (Day 1 - 7) after each vaccination
Other outcomes:
Locations:
city: Marlborough
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Salisbury
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Truro
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Rakvere
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Weinheim
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: Goch
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Min JY, Mwakingwe-Omari A, Riley M, Molo LY, Soni J, Girard G, Danier J. The adjuvanted recombinant zoster vaccine co-administered with the 13-valent pneumococcal conjugate vaccine in adults aged >/=50 years: A randomized trial. J Infect. 2022 Apr;84(4):490-498. doi: 10.1016/j.jinf.2021.12.033. Epub 2021 Dec 25.