Immune Response to Shingles Vaccination
Condition: Shingles
MeSH terms: Herpes Zoster
Intervention: Zoster Vaccine Live
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

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

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:

          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.