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Virus Therapy

Shingrix Vaccine for Shingles

Phase 4
Recruiting
Led By Christine M Johnston, MD, MPH
Research Sponsored by University of Washington
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 up to 1 year after vaccination
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will test if a new shingles vaccine is effective in reducing the risk of shingles and its complications.

Who is the study for?
This trial is for healthy adults in two age groups: 30-40 and 70 or older, who do not have HIV. Participants should not have active hepatitis B or C, history of organ transplants, be immunosuppressed due to illness or drugs, pregnant, planning pregnancy soon after vaccination, prone to excessive scarring or bleeding disorders. They must also never have received a Shingrix vaccine before.
What is being tested?
The study tests the effect of the Shingrix vaccine on specific immune cells in the skin and blood that fight against the varicella-zoster virus (VZV), which causes chickenpox and shingles. The goal is to understand how well these cells are generated after getting an intramuscular shot of Shingrix.
What are the potential side effects?
Shingrix may cause pain at injection site, muscle pain, tiredness, headache, shivering fever and upset stomach. Severe allergic reactions are rare but can occur with any vaccine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year after vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after vaccination for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cytokine profile of gE-specific CD4 T cells in blood
Germanium
Germanium

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: 70 years of age or olderExperimental Treatment1 Intervention
Group II: Cohort 1: 30-40 year of ageExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Shingrix
2019
Completed Phase 4
~530

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,282 Total Patients Enrolled
University of WashingtonLead Sponsor
1,817 Previous Clinical Trials
1,914,332 Total Patients Enrolled
Christine M Johnston, MD, MPHPrincipal InvestigatorUniversity of Washington

Media Library

Shingrix (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04403139 — Phase 4
Congenital Varicella Syndrome Research Study Groups: Cohort 2: 70 years of age or older, Cohort 1: 30-40 year of age
Congenital Varicella Syndrome Clinical Trial 2023: Shingrix Highlights & Side Effects. Trial Name: NCT04403139 — Phase 4
Shingrix (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04403139 — Phase 4
~3 spots leftby Feb 2025
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