Immune Response to Shingles Vaccination

The purpose of this study is to learn more about the immune response to varicella zoster virus (VZV).

Study Overview

• Status: Completed
• Conditions: Shingles
• Intervention / Treatment: Drug: Zoster Vaccine Live

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington Virology Research Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

1. Has an acute or chronic medical condition that, in the opinion of the investigator, would render biopsies unsafe
2. History of coagulopathy or taking medication that may cause bleeding (long term aspirin, heparin, coumadin)
3. History of keloid formation or excessive scarring
4. History of frequent cellulitis or boils (>3 episodes in past 2 years) requiring antibiotic therapy.
5. Allergy to lidocaine, silver nitrate, or mupirocin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 persons over 70 years of age that received Zostavax; 10 persons over 70 years of age that received Zostavax (single 0.65-mL dose subcutaneously in the deltoid region of the upper arm)	Drug: Zoster Vaccine Live; Other Names: ZOSTAVAX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
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	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events Due to Zostavax	To measure the occurrence of adverse events after Zostavax.	6 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: December 2, 2015
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimate): December 8, 2015

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster
• Other Study ID Numbers: STUDY00001399; 53354 (Other Grant/Funding Number: Merck)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO