Clinical trial NCT02624375: Immune Response to Shingles Vaccination
Official title: Immune Response to Shingles Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Shingles
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2015-12-08
Enrollment: 10
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood
timeFrame: 6 months
measure: Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of Participants With Adverse Events Due to Zostavax
timeFrame: 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Virology Research Clinic
state: Washington
Study officials:
References: