Herpes Zoster
Conditions
Interventions
Trade Name: SHINGRIX
Product Name: Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A)
Product Code: HZ/su
Pharmaceutical Form: Powder and suspension for suspension for injection
INN or Proposed INN:
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 71 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Long-term follow-up (LTFU) phase - Immunogenicity assessment •To evaluate persistence of humoral immunity after primary vaccination course. Revaccination active phase - Immunogenicity assessment •To evaluate humoral immunity of Herpes zoster subunit (HZ/su) vaccine post-revaccination Doses 1 & 2.;Secondary Objective: LTFU phase - Immunogenicity assessment •To evaluate persistence of cellular immunity after primary vaccination course. LTFU phase - safety assessment •To evaluate safety of HZ/su vaccine from the study ZOSTER-041 last visit to study ZOSTER-073 Visit 3. Revaccination active phase - Immunogenicity assessment •To evaluate cell-mediated immunity post-revaccination Doses 1 & 2. Revaccination follow-up phase – Immunogenicity assessment •To evaluate persistence of humoral and cell-mediated immune responses post-revaccination Dose 2. Revaccination active and follow-up phases - Safety assessment •To evaluate reactogenicity and safety of the HZ/su vaccine after each revaccination.;Primary end point(s): 1. Evaluation of persistence of humoral immunity in terms of anti-glycoprotein E (anti-gE) antibody concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 1 in the LTFU phase 2. Anti-gE antibody concentrations as determined by ELISA at Month 12, in the LTFU phase 3. Anti-gE antibody concentrations as determined by ELISA at Month 24, in the LTFU phase 4. Anti-gE antibody concentrations as determined by ELISA at pre-revaccination, in the revaccination active phase 5. Anti-gE antibody concentrations as determined by ELISA at 1-month post-revaccination dose 1, in the revaccination active phase 6. Anti-gE antibody concentrations as determined by ELISA at 1-month post-revaccination Dose 2 in the revaccination active phase;Timepoint(s) of evaluation of this end point: 1. At Day 1 2. At Month 12 3. At Month 24 4. At Month 24 (pre-vaccination) 5. At Month 25 6. At Month 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Evaluation of cell-mediated immune (CMI) responses in terms of frequencies of gE-specific CD4+ T-cells as determined by Intracellular Cytokine Staining (ICS) at day 1, in the LTFU phase 2. Frequencies of gE-specific CD4+ T-cells as determined by ICS, at month 12, in the LTFU phase 3. Frequencies of gE-specific CD4+ T-cells as determined by ICS, at month 24 in the LTFU phase 4. Percentage of subjects with any Serious Adverse Events (SAEs) related to primary vaccination in the LTFU phase 5. Number of subjects with history of suspected or confirmed Herpes Zoster (HZ) episode in the LTFU phase 6. Number of subjects with a confirmed HZ episode in the LTFU phase 7. Number of subjects with a history of suspected or biopsy-proven allograft rejections in the LTFU phase 8. Number of subjects with biopsy-proven allograft rejections in the LTFU phase 9. Number of subjects with allograft dysfunction related to allograft rejection episodes in the LTFU phase 10. Number of subjects with allograft dysfunction related to HZ episodes in the LTFU phase 11. Frequencies of gE-specific CD4+ T-cells as determined by ICS, at pre-vaccination in the Revaccination active phase 12. Frequencies of gE-specific CD4+ T-cells as determined by ICS, at month 25 in the Revaccination active phase 13. Frequencies of gE-specific CD4+ T-cells as determined by ICS, at month 26 in the Revaccination active phase 14. Anti-gE antibody concentrations as determined by ELISA at 12 months post-revaccination Dose 2, in the Revaccination follow-up phase 15. Anti-gE antibody concentrations as determined by ELISA at 24 months post-revaccination Dose 2, in the Revaccination follow-up phase 16. Frequencies of gE-specific CD4+ T-cells as determined by ICS at month 37 in the Revaccination follow-up phase 17. Frequencies of gE-specific CD4+ T-cells as determined by ICS at month 49 in the Revaccination follow-up phase 18. Percentage of subjects with at least one solicited local Adv | — |
Countries
Belgium, Canada, Finland, Korea, Republic of, Panama, Spain, Taiwan
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed