Immune Response to Shingles Vaccination



Status:Recruiting
Conditions:Shingles, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:70 - Any
Updated:4/17/2018
Start Date:February 2016
End Date:December 2018
Contact:Study Coordinator Virology Research Clinic
Email:vrc@uw.edu
Phone:206-520-4340

Use our guide to learn which trials are right for you!

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

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.

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.
We found this trial at
1
site
Seattle, Washington 98122
Principal Investigator: Christine Johnston, MD, MPH
Phone: 206-520-4340
?
mi
from
Seattle, WA
Click here to add this to my saved trials