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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Anne A. Gershon, Columbia University
ClinicalTrials.gov Identifier:
NCT01288014
First received: January 31, 2011
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition
Immunity; Defect Due to Antibody or Cell Mediated Immune Defect

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Relationship of Cytokine Production and Immune Responses to Varicella Zoster Virus (VZV) in Elderly Recipients of Zoster Vaccine

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Development of antibodies, cellular immunity, and cytokines before and after vaccination [ Time Frame: Up to week 6 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Blood samples


Estimated Enrollment: 26
Study Start Date: January 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Relatively healthy and over 60 years old

Exclusion Criteria:

  • Having already received Zostavax
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288014

Locations
United States, New York
Vanderbilt Clinic, Columbia University Medical Center
New York, New York, United States, 10128
Sponsors and Collaborators
Columbia University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Anne A. Gershon, MD Columbia University
  More Information

No publications provided

Responsible Party: Anne A. Gershon, Professor of Pediatrics, Director of the Division of Pediatric Infectious Disease, Columbia University
ClinicalTrials.gov Identifier: NCT01288014     History of Changes
Other Study ID Numbers: AAAE1779
Study First Received: January 31, 2011
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
immune response
varicella zoster virus (VZV)
cytokine levels
immunization

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 21, 2014