Herpes Zoster Vaccine for Shingles

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlaxoSmithKline

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial evaluates how well a shingles vaccine works and its safety over several years after initial vaccination. It also looks at immune responses and safety after giving two more doses several years later. Previous studies demonstrated the vaccine's effectiveness for a few years after vaccination.

Eligibility Criteria

Adult kidney transplant recipients who previously completed the HZ/su vaccine course in study ZOSTER-041, without recent organ rejection or other significant illnesses. Women must either be non-childbearing or use contraception and have a negative pregnancy test before revaccination.

Inclusion Criteria

I haven't had a transplant rejection in the last 3 months.

I am a woman who cannot become pregnant due to medical reasons.

I completed the 2-dose HZ/su vaccine course in the ZOSTER-041 study.

+4 more

Exclusion Criteria

Pregnant or lactating female.

I will not receive a live vaccine 30 days before or after the study vaccine doses.

History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.

+14 more

Participant Groups

The trial is testing the long-term immune response to GSK's Herpes Zoster subunit vaccine in kidney transplant patients. It evaluates safety over 7 years post-initial vaccination and checks immune responses after two additional doses given 6-8 years later.

1Treatment groups

Experimental Treatment

Group I: HZ/su GroupExperimental Treatment1 Intervention

Eligible adult participants with renal transplant taking daily chronic immunosuppressive therapy who had a complete 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study. 47 of these participants further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of the current ZOSTER-073 (NCT04176939) study, first dose at Month 24 and second dose at Month 25.