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A Study on the Immune Response and Safety of a Vaccine Against Herpes Zoster in Adults Aged 50 Years and Older in India

Primary Purpose

Herpes Zoster

Status
Active
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
HZ/su
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Herpes Zoster focused on measuring Shingles, Herpes Zoster subunit vaccine, Immunogenicity, Safety, Adults aged 50 years and older, India

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants and/or participant's legally acceptable representative(s) (LAR) who in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written or witnessed/thumb printed informed consent obtained from the participant and/or participant's LAR(s) after the study has been explained according to local regulatory requirements and prior to performance of any study-specific procedure.
  • A male or female aged 50 YOA or older at the time of the first study intervention.
  • Healthy participants or medically stable patients as established by medical history and clinical examination before entering into the study.
  • Female participants of non-childbearing potential may be enrolled in the study.
  • Female participants of childbearing potential may be enrolled in the study, if the participant:

    • has practiced adequate contraception for 1 month prior to study intervention administration, and
    • has a negative pregnancy test on the day of study intervention administration, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study intervention administration series.

Exclusion Criteria:

Medical conditions

  • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s) vaccine or study materials or equipment.
  • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of HZ.
  • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.

Prior/Concomitant therapy

• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before first dose and ending 30 days after the last dose of study intervention administration with the exception of licensed pneumococcal vaccines and non-replicating vaccines may be administered up until 8 days prior to Dose 1 and/or Dose 2 and/or at least 14 days after any dose of study intervention.

[In case an emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is recommended and/or organised by the public health authorities, outside the routine immunisation programme, the time period described above can be reduced if necessary for that vaccine provided it is used according to local governmental recommendations and that the Sponsor is notified accordingly.]

  • Planned administration of long-acting immune-modifying drugs at any time during the study period.
  • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study intervention up to 1 month post-dose 2 (Month 3) or planned administration during the study period.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine. For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day or equivalent is not allowed. Inhaled, intra-articular and topical steroids are allowed.
  • Previous vaccination against varicella or HZ.

Prior/Concurrent clinical study experience Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/ invasive medical device).

Other exclusions

  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months of last study intervention administration.
  • Indications of drug abuse or excess alcohol use as deemed by investigator to potentially confound safety assessments or render participant unable or unlikely to adhere to protocol requirements.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HZ/su Group

Placebo Group

Arm Description

Participants randomized to the HZ/su Group receive two doses of the HZ/su vaccine.

Participants randomized to the Placebo Group receive two doses of Placebo.

Outcomes

Primary Outcome Measures

Percentage of participants showing a vaccine response for anti-glycoprotein E (gE)
A participant with vaccine response for anti-gE is defined as a participant with: a 4-fold increase in the post-last vaccination anti-gE antibody (Ab) concentration as compared to the pre-vaccination anti-gE Ab concentration, for participants who are seropositive at baseline, or a 4-fold increase in the post-last vaccination anti-gE Ab concentration as compared to the anti-gE Ab cut-off value for seropositivity, for participants who are seronegative at baseline.

Secondary Outcome Measures

Anti-gE antibody concentrations expressed as geometric mean concentrations (GMCs) and between-group GMC ratios
Percentage of participants reporting solicited administration site events
The solicited administration site events include injection site pain, redness, swelling and pruritis.
Percentage of participants reporting solicited systemic events
The solicited systemic events include fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia and shivering.
Percentage of participants reporting unsolicited adverse events (AEs)
An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent.
Percentage of participants reporting serious adverse events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or an abnormal pregnancy outcome, or an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.
Percentage of participants reporting potential immune-mediated diseases (pIMDs)
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Percentage of participants reporting SAEs
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or an abnormal pregnancy outcome, or an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.
Percentage of participants reporting pIMDs
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Anti-gE antibody concentrations expressed as GMCs
Percentage of participants seropositive for anti-gE antibodies
A participant seropositive for anti-gE antibodies is defined as a participant whose antibody concentration is greater than or equal to the assay cut-off value (97 mIU/mL).
Mean geometric increase (MGI) of anti-gE antibody concentrations
MGI is defined as the geometric mean of the within participant ratios of anti-gE antibody concentration at 1 month post-dose 2 (Month 3) compared to pre-study intervention administration (Day 1) anti-gE antibody concentration.

Full Information

First Posted
January 21, 2022
Last Updated
January 6, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT05219253
Brief Title
A Study on the Immune Response and Safety of a Vaccine Against Herpes Zoster in Adults Aged 50 Years and Older in India
Official Title
A Phase 3, Randomised, Observer-blind, Placebo-controlled, Multi-centre Study to Evaluate the Immune Response and Safety of the Herpes Zoster Subunit Vaccine When Administered Intramuscularly on a 2-dose Schedule in Adults Aged 50 Years and Older in India
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
October 11, 2022 (Actual)
Study Completion Date
April 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the humoral immunogenicity and safety of 2 doses of GSK Biologicals' Herpes Zoster subunit vaccine (HZ/su) administered for the prevention of Herpes Zoster (HZ) in adults aged 50 years of age (YOA) or older from India.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster
Keywords
Shingles, Herpes Zoster subunit vaccine, Immunogenicity, Safety, Adults aged 50 years and older, India

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Data will be collected in an observer-blind manner.
Allocation
Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HZ/su Group
Arm Type
Experimental
Arm Description
Participants randomized to the HZ/su Group receive two doses of the HZ/su vaccine.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Participants randomized to the Placebo Group receive two doses of Placebo.
Intervention Type
Biological
Intervention Name(s)
HZ/su
Intervention Description
Two doses of the HZ/su vaccine administered intramuscularly, one each at Day 1 and Month 2.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) administered intramuscularly, one each at Day 1 and Month 2.
Primary Outcome Measure Information:
Title
Percentage of participants showing a vaccine response for anti-glycoprotein E (gE)
Description
A participant with vaccine response for anti-gE is defined as a participant with: a 4-fold increase in the post-last vaccination anti-gE antibody (Ab) concentration as compared to the pre-vaccination anti-gE Ab concentration, for participants who are seropositive at baseline, or a 4-fold increase in the post-last vaccination anti-gE Ab concentration as compared to the anti-gE Ab cut-off value for seropositivity, for participants who are seronegative at baseline.
Time Frame
At 1 month post-dose 2 of study intervention administration (Month 3)
Secondary Outcome Measure Information:
Title
Anti-gE antibody concentrations expressed as geometric mean concentrations (GMCs) and between-group GMC ratios
Time Frame
At 1 month post-dose 2 of study intervention administration (Month 3)
Title
Percentage of participants reporting solicited administration site events
Description
The solicited administration site events include injection site pain, redness, swelling and pruritis.
Time Frame
Within 7 days after each study intervention dose and across doses (vaccine/placebo administered at Day 1 and Month 2)
Title
Percentage of participants reporting solicited systemic events
Description
The solicited systemic events include fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia and shivering.
Time Frame
Within 7 days after each study intervention dose and across doses (vaccine/placebo administered at Day 1 and Month 2)
Title
Percentage of participants reporting unsolicited adverse events (AEs)
Description
An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent.
Time Frame
Within 30 days after any study intervention dose administration (vaccine/placebo administered at Day 1 and Month 2)
Title
Percentage of participants reporting serious adverse events (SAEs)
Description
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or an abnormal pregnancy outcome, or an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.
Time Frame
From Day 1 up to Month 3
Title
Percentage of participants reporting potential immune-mediated diseases (pIMDs)
Description
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time Frame
From Day 1 up to Month 3
Title
Percentage of participants reporting SAEs
Description
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or an abnormal pregnancy outcome, or an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.
Time Frame
From Day 1 up to study end (Month 8)
Title
Percentage of participants reporting pIMDs
Description
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time Frame
From Day 1 up to study end (Month 8)
Title
Anti-gE antibody concentrations expressed as GMCs
Time Frame
At pre-study intervention administration (Day 1) and at 1 month post-dose 2 of study intervention administration (Month 3)
Title
Percentage of participants seropositive for anti-gE antibodies
Description
A participant seropositive for anti-gE antibodies is defined as a participant whose antibody concentration is greater than or equal to the assay cut-off value (97 mIU/mL).
Time Frame
At pre-study intervention administration (Day 1) and at 1 month post-dose 2 of study intervention administration (Month 3)
Title
Mean geometric increase (MGI) of anti-gE antibody concentrations
Description
MGI is defined as the geometric mean of the within participant ratios of anti-gE antibody concentration at 1 month post-dose 2 (Month 3) compared to pre-study intervention administration (Day 1) anti-gE antibody concentration.
Time Frame
At 1 month post-dose 2 of study intervention administration (Month 3) compared to pre-study intervention administration (Day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants and/or participant's legally acceptable representative(s) (LAR) who in the opinion of the investigator, can and will comply with the requirements of the protocol. Written or witnessed/thumb printed informed consent obtained from the participant and/or participant's LAR(s) after the study has been explained according to local regulatory requirements and prior to performance of any study-specific procedure. A male or female aged 50 YOA or older at the time of the first study intervention. Healthy participants or medically stable patients as established by medical history and clinical examination before entering into the study. Female participants of non-childbearing potential may be enrolled in the study. Female participants of childbearing potential may be enrolled in the study, if the participant: has practiced adequate contraception for 1 month prior to study intervention administration, and has a negative pregnancy test on the day of study intervention administration, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study intervention administration series. Exclusion Criteria: Medical conditions Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s) vaccine or study materials or equipment. Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). History of HZ. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study. Prior/Concomitant therapy • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before first dose and ending 30 days after the last dose of study intervention administration with the exception of licensed pneumococcal vaccines and non-replicating vaccines may be administered up until 8 days prior to Dose 1 and/or Dose 2 and/or at least 14 days after any dose of study intervention. [In case an emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is recommended and/or organised by the public health authorities, outside the routine immunisation programme, the time period described above can be reduced if necessary for that vaccine provided it is used according to local governmental recommendations and that the Sponsor is notified accordingly.] Planned administration of long-acting immune-modifying drugs at any time during the study period. Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study intervention up to 1 month post-dose 2 (Month 3) or planned administration during the study period. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine. For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day or equivalent is not allowed. Inhaled, intra-articular and topical steroids are allowed. Previous vaccination against varicella or HZ. Prior/Concurrent clinical study experience Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/ invasive medical device). Other exclusions Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months of last study intervention administration. Indications of drug abuse or excess alcohol use as deemed by investigator to potentially confound safety assessments or render participant unable or unlikely to adhere to protocol requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Visakhapatnam
State/Province
Andhra Pradesh
Country
India
Facility Name
GSK Investigational Site
City
North Guwahati
State/Province
Assam
ZIP/Postal Code
781031
Country
India
Facility Name
GSK Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380005
Country
India
Facility Name
GSK Investigational Site
City
Mumbai
State/Province
Maharashtra
Country
India
Facility Name
GSK Investigational Site
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160012
Country
India
Facility Name
GSK Investigational Site
City
Kanpur
ZIP/Postal Code
208002
Country
India
Facility Name
GSK Investigational Site
City
Mysore
ZIP/Postal Code
570004
Country
India
Facility Name
GSK Investigational Site
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
GSK Investigational Site
City
Pune
ZIP/Postal Code
412216
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Learn more about this trial

A Study on the Immune Response and Safety of a Vaccine Against Herpes Zoster in Adults Aged 50 Years and Older in India

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