Immune Response to Shingles Vaccination

Shingles Clinical Trial

Official title:

Immune Response to Shingles Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02624375
• Other study ID #: STUDY00001399
• Secondary ID: 53354
• Status: Completed
• Phase: Phase 4
• Start date: February 2016
• Est. completion date: November 2019

Study information

• Verified date: December 2019
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Zoster
• Shingles

Intervention

Drug:
• Zoster Vaccine Live

Locations

Country	Name	City	State
United States	University of Washington Virology Research Clinic	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood	To determine if Zostavax, when given as FDA indicated, boosts VZV-specific T-cells in the blood	6 months
Primary	Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin	To determine if shingles disease boosts the local level of VZV-specific T cells in skin 4 weeks after Zostavax	4 weeks
Secondary	Number of Participants With Adverse Events Due to Zostavax	To measure the occurrence of adverse events after Zostavax.	6 months