Immune Response to Shingles Vaccination

NCT ID: NCT02624375

Last Updated: 2019-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2019-11-30

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.

Conditions

Shingles

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Zoster Vaccine Live

Intervention Type: DRUG

Interventions

Zoster Vaccine Live

Intervention Type: DRUG

Other Intervention Names

ZOSTAVAX

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Christine Johnston

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Washington Virology Research Clinic

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

53354

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00001399

Identifier Type: -

Identifier Source: org_study_id