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Cancer Vaccine

HZ/su Vaccine for Shingles

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 1-month post-dose 2 in the zoster-006/022 studies until the end of the zoster-101 study at month 48
Awards & highlights

Study Summary

This trial will assess the long-term efficacy, immunogenicity, and safety of the herpes zoster subunit vaccine in older adults.

Who is the study for?
This trial is for older adults who previously participated in the ZOSTER-049 study and received at least one dose of the HZ/su vaccine. They must be medically stable, able to follow the study's procedures, and have given informed consent. Those currently using or planning to use unregistered treatments for shingles or chickenpox, with conditions posing additional risks, or participating in other studies on such infections cannot join.Check my eligibility
What is being tested?
The study is examining the long-term effectiveness and safety of the HZ/su vaccine against shingles up to approximately 11-15 years after initial vaccination. It also looks at how long immune responses last and assesses safety following one or two extra doses given about five years later.See study design
What are the potential side effects?
While specific side effects are not listed here, vaccines like HZ/su may cause reactions where injected (pain, redness), general symptoms like fever, fatigue, headaches as well as muscle pain. Serious side effects are rare but will be monitored throughout this long-term study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 1-month post-dose 2 in the zoster-006/022 studies until the end of the zoster-101 study at month 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 1-month post-dose 2 in the zoster-006/022 studies until the end of the zoster-101 study at month 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Anti-glycoprotein E (gE) antibody concentrations
Frequency of gE-specific Cluster of Differentiation (CD)4+ T-cells secreting at least two activation markers from among IFN-γ, IL-2, TNF-α, CD40L
Number of participants in LTFU and Control groups with confirmed HZ cases
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Revaccination GroupExperimental Treatment1 Intervention
Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and two additional doses of the HZ/su vaccine in the ZOSTER-049 study and are followed for persistence of immunogenicity and safety in the current ZOSTER-101 study.
Group II: LTFU GroupExperimental Treatment1 Intervention
Participants who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and are followed for long-term vaccine efficacy and safety in the current ZOSTER-101 study.
Group III: Control GroupExperimental Treatment1 Intervention
Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the ZOSTER-049 study, but who served as a control for the two groups that received 1 or 2 additional doses of HZ/su (1-Additional Dose and Revaccination groups). In the current ZOSTER-101 study, this Control group is used in the evaluation of the long-term vaccine efficacy, safety and as a control for persistence of immunogenicity to additional doses administered in ZOSTER-049 study.
Group IV: 1-Additional Dose GroupExperimental Treatment1 Intervention
Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and one additional dose of the HZ/su vaccine in the ZOSTER-049 study and are followed for persistence of immunogenicity and safety in the current ZOSTER-101 study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HZ/su vaccine
2014
Completed Phase 1
~160

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,766 Previous Clinical Trials
8,102,548 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,596 Previous Clinical Trials
6,141,300 Total Patients Enrolled

Media Library

HZ/su vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05371080 — Phase 3
Shingles Research Study Groups: 1-Additional Dose Group, Revaccination Group, Control Group, LTFU Group
Shingles Clinical Trial 2023: HZ/su vaccine Highlights & Side Effects. Trial Name: NCT05371080 — Phase 3
HZ/su vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05371080 — Phase 3
~1924 spots leftby Aug 2027
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