Immune Response to Shingles Vaccination

NCT02624375 | Completed Phase 4 Results DMC

• 2 other identifiers: STUDY0000139953354
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Shingles

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Number of Participants With Adverse Events Due to Zostavax

  6 months

Study Arms (1)

10 persons over 70 years of age that received Zostavax

EXPERIMENTAL

10 persons over 70 years of age that received Zostavax (single 0.65-mL dose subcutaneously in the deltoid region of the upper arm)

Drug: Zoster Vaccine Live

Interventions

Zoster Vaccine Live DRUG

Also known as: ZOSTAVAX

10 persons over 70 years of age that received Zostavax

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age or older.
• History of chickenpox.

You may not qualify if:

• 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.
• 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.
• Has an acute or chronic medical condition that, in the opinion of the investigator, would render biopsies unsafe
• History of coagulopathy or taking medication that may cause bleeding (long term aspirin, heparin, coumadin)

Sponsors & Collaborators

• University of Washington: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Washington Virology Research Clinic

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. Christine Johnston, Associate Professor
• Organization: University of Washington

cjohnsto@uw.edu

206 520 4340

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 8, 2015
• Study Start: February 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: December 5, 2019
• Results First Posted: December 5, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)