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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year after vaccination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year after vaccination
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cytokine profile of gE-specific CD4 T cells in blood
Germanium
Germanium
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
~500
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,693 Previous Clinical Trials
28,027,185 Total Patients Enrolled
1 Trials studying Chickenpox
33 Patients Enrolled for Chickenpox
University of WashingtonLead Sponsor
1,751 Previous Clinical Trials
1,840,131 Total Patients Enrolled
Christine M Johnston, MD, MPHPrincipal InvestigatorUniversity of Washington
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to lidocaine, silver nitrate, or mupirocin.You have received the Shingrix, Zostavax, or chickenpox vaccines in the past.You have a history of developing big scars or keloids.You have received an organ transplant or a stem cell transplant in the past.You have a history of bleeding problems or take medications that increase the risk of bleeding, like high doses of aspirin, heparin, or coumadin (except for low-dose aspirin under 100 mg per day).You have had frequent cases of skin infections like cellulitis or boils, requiring antibiotics three or more times in the past two years.You have had a severe allergic reaction in the past to any ingredient in the vaccine that could be life-threatening.You have a serious autoimmune disease like rheumatoid arthritis or multiple sclerosis that requires strong medication to control.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2: 70 years of age or older
- Group 2: Cohort 1: 30-40 year of age
Awards:
This trial has 3 awards, including:- 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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