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

Launched by GLAXOSMITHKLINE · Nov 22, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the long-term immune response to a herpes zoster vaccine in adults who have previously received the vaccine after having a kidney transplant. Researchers want to see how well the vaccine continues to work over time, up to seven years after the initial two doses, and whether giving two additional doses later can be safe and helpful in boosting the immune response.

To participate in this trial, individuals must have previously completed the full vaccination series in an earlier study and be able to follow the study's rules. They should not have had any serious health problems recently that would prevent them from being part of the study. Participants can expect to receive the additional vaccine doses and will be monitored for their immune response and safety throughout the study. It's important to note that women who can become pregnant will need to use effective birth control and have a negative pregnancy test before receiving the additional doses.

Gender

ALL

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.