T Cell Responses to Varicella Zoster Virus (VZV) Vaccine SLVP020
Condition: Herpes Zoster
MeSH terms: Herpes Zoster; Chickenpox
Intervention: Zostavax™
Intervention description: In the Vaccination arm, healthy individuals will be vaccinated with the licensed zoster vaccine, Zostavax.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Herpes zoster; immune response; Zostavax; twins; non-twins

Summary:

      In this study the investigators are trying to identify immune signatures that are associated
      with effective or poor vaccine responses to naturally-acquired herpes zoster virus and the
      zoster (shingles) vaccine, Zostavax.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Otherwise healthy adult non-twins and twin pairs, 40-49 years of age (Cross-Sectional
             study) or 50 years of age and older (Vaccination study). If a volunteer cannot
             participate in the Vaccination study after screening, may be considered for
             Cross-Sectional study.

          -  History of prior chicken pox infection or living within the continental U.S. for past
             30 years

          -  Willing to complete the informed consent process

          -  Availability for follow-up for the planned duration of the study (Cross-Sectional
             study: 1 visit; Vaccination study: 5 visits within 4-5 weeks)

          -  Acceptable medical history and vital signs

        Exclusion Criteria:

          -  History of shingles within 5 years of enrollment

          -  Prior vaccination with Zostavax vaccine for prevention of shingles

          -  Vaccination Study only: History of severe allergic reactions to vaccine components,
             including gelatin and neomycin.

          -  Vaccination Study only: Life-threatening reactions to previous vaccinations.

          -  Vaccination Study only: Adults weighing less than 110 pounds.

          -  Active systemic or serious concurrent illness, including febrile illness on the day of
             enrollment/vaccination

          -  History of immunodeficiency disorder

          -  Chronic HIV, Hepatitis B or Hepatitis C infection

          -  Known or suspected impairment of immunologic function, including, but not limited to
             clinically significant liver disease, diabetes mellitus treated with insulin, moderate
             to severe renal disease or any other chronic disorder which, in the opinion of the
             investigator, might jeopardize volunteer safety or compliance with the protocol.

          -  Recent or current use of immunosuppressive medication, or anticipated use during study
             period, including systemic corticosteroids (corticosteroid nasal sprays, inhaled
             steroids and topical steroids are permissible).

          -  Blood pressure >150 systolic or > 95 diastolic at Visit 1

          -  History of chemotherapy treatment for cancer.

          -  Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors
             such as breast cancer with recurrence in the past year and any hematologic cancer such
             as leukemia or lymphoma) which, in the opinion of the investigator, might jeopardize
             volunteer safety or compliance with the protocol. Prostate cancer may be acceptable if
             no metastases and not undergoing treatment with immunosuppressive medications.

          -  Autoimmune disease, including rheumatoid arthritis, treated with immunosuppressive
             medication such as Plaquenil, methotrexate, prednisone, Enbrel, which in the opinion
             of the investigator, might jeopardize volunteer safety or compliance with the protocol
             (thyroid disease may be acceptable).

          -  History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
             medical follow up or hospitalization during the preceding year

          -  Use of anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet
             agents such as aspirin (except aspirin up to 325 mg. daily), Plavix or Aggrenox which
             may, in the opinion of the investigator, jeopardize volunteer safety or compliance
             with the protocol.

          -  Receipt of blood or blood products within 6 months prior to enrollment and during the
             study period

          -  Use of antiviral medications within 24 hrs. prior to enrollment, and for the
             Vaccination study, for the 14 days following study vaccination.

          -  Inactivated vaccine within 14 days prior to enrollment and during study period(avoid
             non-study related immunization during the study period)

          -  Live, attenuated vaccine within 60 days prior to enrollment and during study period
             (avoid non-study related immunization during the study period)

          -  Pregnant or lactating woman, planning to become pregnant (pregnancy should be avoided
             for 3 months following administration of Zostavax vaccine).

          -  Use of investigational agents within 30 days prior to enrollment and during study
             period

          -  Donation of a unit of blood within 6 weeks prior to enrollment and during study period

          -  Medical or psychiatric condition or occupational responsibilities that preclude
             subject compliance with the protocol

          -  Any condition which, in the opinion of the investigator, might interfere with
             volunteer safety, study objectives or the ability of the participant to understand or
             comply with the study protocol.