Cytokine Production and Immunity to Varicella Zoster Virus (VZV) in Elderly Recipients of Zoster Vaccine

Relationship of Cytokine Production and Immune Responses to Varicella Zoster Virus (VZV) in Elderly Recipients of Zoster Vaccine

After immunization, particularly in older persons, some people are protected from disease by a vaccine and others are not. The investigators believe that this variable response may be due to overproduction of molecules that suppress development of immunity (antibodies and cell mediated immunity). Normally, these molecules are produced to make sure that immunity is regulated in just the right way for the body as a whole, and to prevent autoimmune disease.

However, with aging, the immune system may have difficulty in proper immune regulation. Over production of immunosuppressive molecules after vaccination may interfere with the effects of a vaccine. For example when elderly individuals are immunized against zoster with a licensed vaccine, Zostavax, the vaccine is effective in only about 50 to 60%. The investigators will compare blood levels of antibodies, cellular immunity, and immunosuppressive molecules in recipients of Zostavax to see if there is a correlation between development low immunity and high levels of immunosuppressive molecules.

Study Overview

• Status: Completed
• Conditions: Immunity; Defect Due to Antibody or Cell Mediated Immune Defect

Detailed Description

In order to determine whether there is a relationship between production of immunosuppressive cytokines (such as IL-10) an lower levels of immunity to Varicella Zoster Virus (VZV) after vaccination, the investigators will obtain blood samples before and 3-5 times after immunization to determine the immunity to VZV and the levels of certain cytokines. The first blood samples will be obtained before the vaccine is given, as baseline values.

The vaccine being used is the licensed vaccine, Zostavax, which is recommended by the Food and Drug Administration (FDA) and Center for Disease Control and Prevention (CDC) to be administered to all relatively healthy individuals over the age of 50. This study does not concern vaccine safety or effectiveness. As a benefit to vaccines, the vaccine is administered at no charge to the subject.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10128
      • Vanderbilt Clinic, Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Relatively healthy people over age 60 who have not had Zostavax previously.

Description

Inclusion Criteria:

• Relatively healthy and over 60 years old

Exclusion Criteria:

• Having already received Zostavax

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Edlerly Recipients of Zoster Vaccine; Blood samples are collected before and after vaccination in people age 60 or more, who are getting the zoster vaccine as part of their routine health care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of antibodies, cellular immunity, and cytokines before and after vaccination	Measure antibodies, cellular immunity, and cytokines in blood before and after immunization. Determine if there is any relationship between development of strong immunity and development of cytokine levels.	Up to week 6

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Anne A. Gershon, MD, Columbia University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: February 1, 2011
• First Posted (Estimate): February 2, 2011

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: immunization; immune response; varicella zoster virus (VZV); cytokine levels
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Chickenpox
• Other Study ID Numbers: AAAE1779