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Virus Therapy

Herpes Zoster Vaccine GSK1437173A 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 at months 0, 12, 24, 36, 48, 60 and 72 (ltfu cmi subset, 1-additional dose, revaccination and control groups), at month 1 (1-additional dose, revaccination and control groups), and at month 3 (revaccination and control groups).
Awards & highlights

Study Summary

This trial is to see if the efficacy, safety, and immunogenicity of GSK Biologicals' Herpes Zoster subunit vaccine persists in the long term, as well as to assess if 1 or 2 additional doses in two subgroups of older adults has any effect.

Eligible Conditions
  • Shingles

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at months 0, 12, 24, 36, 48, 60 and 72 (ltfu cmi subset, 1-additional dose, revaccination and control groups), at month 1 (1-additional dose, revaccination and control groups), and at month 3 (revaccination and control groups).
This trial's timeline: 3 weeks for screening, Varies for treatment, and at months 0, 12, 24, 36, 48, 60 and 72 (ltfu cmi subset, 1-additional dose, revaccination and control groups), at month 1 (1-additional dose, revaccination and control groups), and at month 3 (revaccination and control groups). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects with confirmed herpes zoster (HZ).cases
Secondary outcome measures
Anti-glicoprotein E (gE) antibody (Ab) concentrations
Cell mediated immunity (CMI) in terms of frequencies of antigen-specific CD4+ T cells.
Postherpetic neuralgia
+8 more

Side effects data

From 2019 Phase 3 trial • 8687 Patients • NCT02690207
37%
Injection site pain
15%
Injection site erythema
12%
Pyrexia
11%
Injection site swelling
8%
Headache
4%
Fatigue
4%
Chills
4%
Myalgia
3%
Malaise
3%
Injection site pruritus
3%
Nasopharyngitis
2%
Pain
2%
Injection site warmth
2%
Arthralgia
2%
Vaccination site pain
2%
Nausea
1%
Diarrhoea
1%
Back pain
1%
Pruritus
1%
Influenza
1%
Injection site inflammation
1%
Dizziness
1%
Body temperature increased
1%
Feeling cold
1%
Administration site pain
1%
Asthenia
1%
Influenza like illness
1%
Injection site induration
1%
Injection site rash
1%
Pain in extremity
1%
Rash
1%
Pneumonia
1%
Vaccination site erythema
1%
Upper respiratory tract infection
1%
Urinary tract infection
1%
Musculoskeletal pain
1%
Cough
1%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
HZ/su Group

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Revaccination Group (Rev Group)Experimental Treatment1 Intervention
Subjects who received 2 doses of the HZ/su vaccine in the primary studies ZOSTER-006/022 and will receive 2 additional doses of the HZ/su vaccine in the current study on a 0, 2 Month schedule (N=60).
Group II: LTFU GroupExperimental Treatment1 Intervention
Long-Term Follow-Up of the subjects who received at least one dose of the HZ/su vaccine in the primary studies ZOSTER-006/022
Group III: Additional Dose Group (1AdD Group)Experimental Treatment1 Intervention
Subjects who received 2 doses of the HZ/su vaccine in the primary studies ZOSTER-006/022 and will receive 1 additional dose of the HZ/su vaccine in the current study.
Group IV: Control Group (Ctrl Group)Placebo Group1 Intervention
Subjects who received 2 doses of the HZ/su vaccine in the primary studies ZOSTER-006/022 and will receive no additional doses of the HZ/su vaccine in the current study and will control for the 1-Additional and Revaccination groups
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Herpes Zoster Vaccine GSK1437173A
2016
Completed Phase 3
~47410

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,755 Previous Clinical Trials
8,063,275 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,136,389 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this particular experiment have any predecessors?

"As of now, there are 17 ongoing studies for Herpes Zoster Vaccine GSK1437173A in 23 different countries. The first study was completed 6 years ago in 2014. That study, sponsored by Bristol-Myers Squibb, Phase 2 drug approval stage. So far, a total of 56 trials have been completed."

Answered by AI

Is this trial taking place across the United States in many different locations?

"To limit participant burden, this clinical trial is enrolling at 38 sites close to subjects. In North carolina, these locations include Hickory, Columbia and Charlotte. There are also 35 other sites across the country."

Answered by AI

Are there any similar ongoing or completed studies involving Herpes Zoster Vaccine GSK1437173A?

"There are 208 research sites running 17 different clinical trials for Herpes Zoster Vaccine GSK1437173A, with 4 of those studies being in Phase 3."

Answered by AI

What are the risks associated with the GSK1437173A Herpes Zoster Vaccine?

"There is pre-existing clinical data supporting the safety of Herpes Zoster Vaccine GSK1437173A, which received a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Texas
Washington
Other
How old are they?
18 - 65
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have HSV-2 and, I have been praying for this.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long do screening visits take?
PatientReceived no prior treatments
Recent research and studies
Clinical Infectious DiseasesJournal
The Adjuvanted Recombinant Zoster Vaccine Confers Long-term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70
Boutry, Céline, Andrew Hastie, Javier Diez-Domingo, Juan Carlos Tinoco, Chong-Jen Yu, Charles Andrews, Jean Beytout, et al.. 2021. “The Adjuvanted Recombinant Zoster Vaccine Confers Long-term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1093/cid/ciab629.
Clinical Infectious DiseasesJournal
The Adjuvanted Recombinant Zoster Vaccine Confers Long-term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70
Boutry, Céline, Andrew Hastie, Javier Diez-Domingo, Juan Carlos Tinoco, Chong-Jen Yu, Charles Andrews, Jean Beytout, et al.. 2021. “The Adjuvanted Recombinant Zoster Vaccine Confers Long-term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1093/cid/ciab629.
clinicaltrials.govStudy
A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults
2016. "A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02723773.
~838 spots leftby Apr 2025
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