Immune Response to Shingles Vaccination
Primary Purpose
Shingles
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Zoster Vaccine Live
Sponsored by
About this trial
This is an interventional basic science trial for Shingles
Eligibility Criteria
Inclusion Criteria:
- 70 years of age or older.
- History of chickenpox.
Exclusion Criteria
- Previous vaccination with Zostavax or with the chickenpox vaccine.
- History of ever having had shingles.
- Been in close contact with a person who had chickenpox or shingles in the past 5 years.
- VZV seronegative
- Taking systemic suppressive regular doses of drugs with anti-VZV activity such as acyclovir, famciclovir, or valacyclovir. Episodic use is allowed. For Cohort 1: medication cannot be taken 24 hours prior to or 30 days after receiving Zostavax per CDC recommendations.
- HIV seropositive.
- Hepatitis C infection or active Hepatitis B infection.
- History of a life-threatening allergic reaction (anaphylactic/anaphylactoid reaction) to gelatin, neomycin, or any other component of shingles vaccine. Neomycin allergy manifested as contact dermatitis is not an exclusion.
- Has immunosuppression as a result of an underlying illness (e.g. leukemia, lymphoma or other malignant neoplasms) or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy.
- Has long-term use of oral or parenteral steroids (>7 days), or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
- Women of child-bearing potential only: pregnant or planning to become pregnant 3 months post vaccination
- Donated blood in the past 8 weeks or planning to donate blood during the study
- Weighs less than 110 lbs
- Has any condition or medical history that would, in the opinion of the site principal investigator place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Additional exclusions for optional skin biopsy:
- Has an acute or chronic medical condition that, in the opinion of the investigator, would render biopsies unsafe
- History of coagulopathy or taking medication that may cause bleeding (long term aspirin, heparin, coumadin)
- History of keloid formation or excessive scarring
- History of frequent cellulitis or boils (>3 episodes in past 2 years) requiring antibiotic therapy.
- Allergy to lidocaine, silver nitrate, or mupirocin.
Sites / Locations
- University of Washington Virology Research Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
10 persons over 70 years of age that received Zostavax
Arm Description
10 persons over 70 years of age that received Zostavax (single 0.65-mL dose subcutaneously in the deltoid region of the upper arm)
Outcomes
Primary Outcome Measures
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood
To determine if Zostavax, when given as FDA indicated, boosts VZV-specific T-cells in the blood
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin
To determine if shingles disease boosts the local level of VZV-specific T cells in skin 4 weeks after Zostavax
Secondary Outcome Measures
Number of Participants With Adverse Events Due to Zostavax
To measure the occurrence of adverse events after Zostavax.
Full Information
NCT ID
NCT02624375
First Posted
December 2, 2015
Last Updated
December 3, 2019
Sponsor
University of Washington
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT02624375
Brief Title
Immune Response to Shingles Vaccination
Official Title
Immune Response to Shingles Vaccination
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to learn more about the immune response to varicella zoster virus (VZV).
Detailed Description
Participants 70 years of age or older will receive the FDA-approved shingles vaccine (Zostavax). Blood samples and optional skin biopsies will be obtained before and after vaccination to study the immune responses to shingles vaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shingles
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10 persons over 70 years of age that received Zostavax
Arm Type
Experimental
Arm Description
10 persons over 70 years of age that received Zostavax (single 0.65-mL dose subcutaneously in the deltoid region of the upper arm)
Intervention Type
Drug
Intervention Name(s)
Zoster Vaccine Live
Other Intervention Name(s)
ZOSTAVAX
Primary Outcome Measure Information:
Title
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood
Description
To determine if Zostavax, when given as FDA indicated, boosts VZV-specific T-cells in the blood
Time Frame
6 months
Title
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin
Description
To determine if shingles disease boosts the local level of VZV-specific T cells in skin 4 weeks after Zostavax
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events Due to Zostavax
Description
To measure the occurrence of adverse events after Zostavax.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
70 years of age or older.
History of chickenpox.
Exclusion Criteria
Previous vaccination with Zostavax or with the chickenpox vaccine.
History of ever having had shingles.
Been in close contact with a person who had chickenpox or shingles in the past 5 years.
VZV seronegative
Taking systemic suppressive regular doses of drugs with anti-VZV activity such as acyclovir, famciclovir, or valacyclovir. Episodic use is allowed. For Cohort 1: medication cannot be taken 24 hours prior to or 30 days after receiving Zostavax per CDC recommendations.
HIV seropositive.
Hepatitis C infection or active Hepatitis B infection.
History of a life-threatening allergic reaction (anaphylactic/anaphylactoid reaction) to gelatin, neomycin, or any other component of shingles vaccine. Neomycin allergy manifested as contact dermatitis is not an exclusion.
Has immunosuppression as a result of an underlying illness (e.g. leukemia, lymphoma or other malignant neoplasms) or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy.
Has long-term use of oral or parenteral steroids (>7 days), or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
Women of child-bearing potential only: pregnant or planning to become pregnant 3 months post vaccination
Donated blood in the past 8 weeks or planning to donate blood during the study
Weighs less than 110 lbs
Has any condition or medical history that would, in the opinion of the site principal investigator place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Additional exclusions for optional skin biopsy:
Has an acute or chronic medical condition that, in the opinion of the investigator, would render biopsies unsafe
History of coagulopathy or taking medication that may cause bleeding (long term aspirin, heparin, coumadin)
History of keloid formation or excessive scarring
History of frequent cellulitis or boils (>3 episodes in past 2 years) requiring antibiotic therapy.
Allergy to lidocaine, silver nitrate, or mupirocin.
Facility Information:
Facility Name
University of Washington Virology Research Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immune Response to Shingles Vaccination
We'll reach out to this number within 24 hrs