Clinical trial NCT04176939: A Study to Test GlaxoSmithKline's (GSK) Herpes Zoster (HZ) Subunit Vaccine's Long-term Immune Response in Previously Vaccinated Kidney Transplant Adults and Then to Test if 2 Additional Doses of the Vaccine Are Safe and Able to Generate an Immune Response
Official title: Long-term Immunogenicity Study of Herpes Zoster Subunit Vaccine (GSK1437173A) and Immunogenicity and Safety Assessment of Revaccination With Two Additional Doses in Adults With Renal Transplant From Study ZOSTER-041
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Herpes Zoster
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2019-11-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to evaluate the long-term immune responses to the Herpes Zoster subunit (HZ/su) vaccine as well as safety up to 7 years after the 2-dose primary vaccination course from study ZOSTER-041 (NCT02058589). This study also assessed immune responses as well as safety after revaccination with 2 additional doses of the HZ/su administered at 6 to 8 years after the 2-dose primary vaccination course.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for enrolment

  * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and subjects' Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
  * Written informed consent obtained from the subject/LAR(s) of the subject prior to performance of any study-specific procedure.
  * Subjects who previously participated in study ZOSTER-041 and completed the full 2 dose HZ/su primary vaccination course.
* Inclusion criteria for revaccination

  * Subjects receiving maintenance CIS therapy for the prevention of allograft rejection for a minimum of one month prior to the first revaccination.
  * Subjects without an episode of allograft rejection within 90 days prior to the first revaccination visit.
  * Female subjects of non-childbearing potential may be revaccinated. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
  * Female subjects of childbearing potential may be revaccinated, if the subject:
* has practiced adequate contraception for 30 days prior to revaccination, and
* has a negative pregnancy test on the day of revaccination, and
* has agreed to continue adequate contraception up to 2 months after completion of the revaccination series.

Exclusion Criteria:

Exclusion criteria for enrolment Medical conditions

* Vaccination against HZ since completion of study ZOSTER-041.
* Significant underlying illness that, in the opinion of the investigator, is expected to prevent completion of the study.
* Any other condition that, in the opinion of the investigator, would interfere with the evaluations required by the study.

Prior/Concurrent clinical study experience

• Concurrently participating in another interventional vaccine or immunosuppressive clinical study, in which the subject is exposed to an investigational or a non-investigational vaccine/product (drug) at any time during the ZOSTER-073 study.

Exclusion criteria for revaccination Medical conditions

* History of confirmed HZ within one year before revaccination visit (Visit 3).
* More than one organ transplanted.
* Any additional confirmed or suspected immunosuppressive or immunodeficient condition.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Any other condition that, in the opinion of the investigator, would interfere with the evaluations required by the study or make vaccination unsafe.

Prior/Concomitant therapy

* Administration or planned administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first revaccination dose of study vaccine and ending at Visit 5 (Month 26).
* Use of anti-CD20 or other B-cell monoclonal antibody agents as maintenance and/or therapeutic immunosuppressive therapy for the prevention of allograft rejection within 9 months of first revaccination dose of study vaccine.
* Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to use of maintenance immunosuppressive therapies.
* Planned administration/administration of a live vaccine in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration.
* Planned administration/administration of a non-replicating or subunit vaccine, not foreseen by the study protocol, in the period starting 8 days before and ending 30 days after each dose of study vaccine.

Other exclusion criteria for revaccination

* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions up to 2 months post-revaccination Dose 2.
* Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe.

Primary outcomes:
measure: Anti-glycoprotein E (Anti-gE) Antibody Concentrations in the Long Term Follow Up (LTFU) Phase of the Current ZOSTER-073 Study
timeFrame: From 3.5 up to less than 4.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
measure: Anti-gE Antibody Concentrations in the LTFU Phase of the Current ZOSTER-073 Study
timeFrame: From 4.5 up to less than 5.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
measure: Anti-gE Antibody Concentrations in the LTFU Phase of the Current ZOSTER-073 Study
timeFrame: From 5.5 up to less than 6.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
measure: Anti-gE Antibody Concentrations in the LTFU Phase of the Current ZOSTER-073 Study
timeFrame: From 6.5 up to less than 7.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
measure: Anti-gE Antibody Concentrations in the LTFU Phase of the Current ZOSTER-073 Study
timeFrame: From 7.5 up to less than 8.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
measure: Anti-gE Antibody Concentrations at Month 24 (Pre-revaccination) in the Revaccination Active Phase of the Current ZOSTER-073 Study
timeFrame: At Month 24 (pre-revaccination) in the current ZOSTER-073 study
measure: Anti-gE Antibody Concentrations at Month 25 (1 Month Post-revaccination Dose 1) in the Revaccination Active Phase of the Current ZOSTER-073 Study
timeFrame: At Month 25 (1 month post-revaccination Dose 1) in the current ZOSTER-073 study
measure: Anti-gE Antibody Concentrations at Month 26 (1 Month Post-revaccination Dose 2) in the Revaccination Active Phase of the Current ZOSTER-073 Study
timeFrame: At Month 26 (1 month post-revaccination Dose 2) in the current ZOSTER-073 study
Secondary outcomes:
measure: Frequency of gE-specific Cluster of Differentiation 4 (CD4) (2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α, and CD40L in the LTFU Phase of the Current ZOSTER-073 Study
timeFrame: From 3.5 up to less than 4.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
measure: Frequency of gE-specific CD4 (2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α and CD40L in the LTFU Phase of the Current ZOSTER-073 Study
timeFrame: From 4.5 up to less than 5.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
measure: Frequency of gE-specific CD4 (2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α and CD40L in the LTFU Phase of the Current ZOSTER-073 Study
timeFrame: From 5.5 up to less than 6.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
measure: Frequency of gE-specific CD4 (2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α and CD40L in the LTFU Phase of the Current ZOSTER-073 Study
timeFrame: From 6.5 up to less than 7.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
measure: Frequency of gE-specific CD4 (2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α and CD40L in the LTFU Phase of the Current ZOSTER-073 Study
timeFrame: From 7.5 up to less than 8.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
measure: Number of Participants With Serious Adverse Events (SAEs) Related to Primary Vaccination, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study
timeFrame: From Month 13 (last visit) in ZOSTER-041 primary study up to Month 24 in the current ZOSTER-073 study. Note: Month 24 was pre-revaccination for those participants who were revaccinated.
measure: Number of Participants With Suspected or Confirmed Herpes Zoster (HZ) Episode, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study
timeFrame: From Month 13 (last visit) in ZOSTER-041 primary study up to Day 1 (first visit) in the current ZOSTER-073 study
measure: Number of Participants With a Confirmed HZ Episode in the LTFU Phase of the Current ZOSTER-073 Study
timeFrame: From Day 1 up to Month 24 in the current ZOSTER-073 study. Note: Month 24 was pre-revaccination for those participants who were revaccinated.
measure: Number of Participants With Suspected or Biopsy-proven Allograft Rejections, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study
timeFrame: From Month 13 (last visit) in ZOSTER-041 primary study up to Day 1 (first visit) in the current ZOSTER-073 study
measure: Number of Participants With Biopsy-proven Allograft Rejections in the LTFU Phase of the Current ZOSTER-073 Study
timeFrame: From Day 1 up to Month 24 in the current ZOSTER-073 study. Note: Month 24 was pre-revaccination for those participants who were revaccinated.
measure: Number of Participants With Allograft Dysfunction Related to Allograft Rejection Episodes, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study
timeFrame: From Month 13 (last visit) in ZOSTER-041 primary study up to Month 24 in the current ZOSTER-073 study. Note: Month 24 was pre-revaccination for those participants who were revaccinated.
measure: Number of Participants With Allograft Dysfunction Related to HZ Episodes, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study
timeFrame: From Month 13 (last visit) in ZOSTER-041 primary study up to Month 24 in the current ZOSTER-073 study. Note: Month 24 was pre-revaccination for those participants who were revaccinated.
measure: Frequency of gE-specific CD4(2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α, and CD40L at Month 24 (Pre-revaccination) in the Revaccination Active Phase of the Current ZOSTER-073 Study
timeFrame: At Month 24 (pre-revaccination) in the current ZOSTER-073 study
measure: Frequency of gE-specific CD4(2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α, and CD40L at Month 25 (1 Month Post-revaccination Dose 1) in the Revaccination Active Phase of the Current ZOSTER-073 Study
timeFrame: At Month 25 (1 month post-revaccination Dose 1) in the current ZOSTER-073 study
measure: Frequency of gE-specific CD4(2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α, and CD40L at Month 26 (1 Month Post-revaccination Dose 2) in the Revaccination Active Phase of the Current ZOSTER-073 Study
timeFrame: At Month 26 (1 month post-revaccination Dose 2) in the current ZOSTER-073 study
measure: Anti-gE Antibody Concentrations at Month 37 (12 Months Post-revaccination Dose 2) in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study
timeFrame: At Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study
measure: Anti-gE Antibody Concentrations at Month 49 (24 Months Post-revaccination Dose 2) in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study
timeFrame: At Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
measure: Frequency of gE-specific CD4(2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α and CD40L at Month 37 (12 Months Post-revaccination Dose 2) in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study
timeFrame: At Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study
measure: Frequency of gE-specific CD4(2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α and CD40L at Month 49 (24 Months Post-revaccination Dose 2) in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study
timeFrame: At Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
measure: Percentage of Participants With Any and Grade 3 Solicited Local Adverse Events (AEs) After Each Revaccination in the Revaccination Active Phase of the Current ZOSTER-073 Study
timeFrame: Within 7 days after each revaccination dose (administered at Month 24 and Month 25) in the current ZOSTER-073 study
measure: Duration in Days of Solicited Local Adverse Events (AEs) After Each Revaccination in the Revaccination Active Phase of the Current ZOSTER-073 Study
timeFrame: Within 7 days after each revaccination dose (administered at Month 24 and Month 25) in the current ZOSTER-073 study
measure: Percentage of Participants With Any, Grade 3 and Related Solicited General Adverse Events (AEs) After Each Revaccination in the Revaccination Active Phase of the Current ZOSTER-073 Study
timeFrame: Within 7 days after each revaccination dose (administered at Month 24 and Month 25) in the current ZOSTER-073 study
measure: Duration in Days of Solicited General Adverse Events (AEs) After Each Revaccination in the Revaccination Active Phase of the Current ZOSTER-073 Study
timeFrame: Within 7 days after each revaccination dose (administered at Month 24 and Month 25) in the current ZOSTER-073 study
measure: Percentage of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Post-revaccination in the Revaccination Active Phase of the Current ZOSTER-073 Study
timeFrame: Within 30 days (across revaccination doses) post-revaccination period in the current ZOSTER-073 study
measure: Percentage of Participants With Any Serious Adverse Events (SAEs) and Fatal SAEs in the Revaccination Active Phase of the Current ZOSTER-073 Study
timeFrame: From Month 24 (pre-revaccination) up to Month 26 (1 month post-revaccination Dose 2) in the current ZOSTER-073 study
measure: Percentage of Participants With Any Serious Adverse Events (SAEs) and Fatal SAEs in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study
timeFrame: From Month 26 (1 month post-revaccination Dose 2) up to Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study
measure: Number of Participants With Related Serious Adverse Events (SAEs) and Related-fatal SAEs in the Revaccination Active Phase of the Current ZOSTER-073 Study
timeFrame: From Month 24 (pre-revaccination) up to Month 26 (1 month post-revaccination Dose 2) in the current ZOSTER-073 study
measure: Number of Participants With Related Serious Adverse Events (SAEs) and Related-fatal SAEs in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study
timeFrame: From Month 26 (1 month post-revaccination Dose 2) up to Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
measure: Number of Participants With Any and Related Biopsy-proven Allograft Rejections in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study
timeFrame: From Month 24 (pre-revaccination) up to Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
measure: Percentage of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs) in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study
timeFrame: From Month 24 (pre-revaccination) up to Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study
measure: Number of Participants With a Confirmed HZ Episode in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study
timeFrame: From Month 24 (pre-revaccination) up to Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
measure: Number of Participants With Allograft Dysfunction Following Revaccination in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study
timeFrame: From Month 24 (pre-revaccination) up to Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study
measure: Number of Participants With Allograft Dysfunction Related to Allograft Rejection in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study
timeFrame: From Month 24 (pre-revaccination) up to Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
measure: Number of Participants With Allograft Dysfunction Related to HZ Episodes in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study
timeFrame: From Month 24 (pre-revaccination) up to Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Panama
country: Panama
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Hospitalet de Llobregat
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Santander
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Taoyuan
country: Taiwan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: