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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01288014
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : July 19, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Anne A. Gershon, Columbia University

Brief Summary:

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 or disease
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
Actual Enrollment : 26 participants
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
Study Start Date : January 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chickenpox Shingles

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.

Primary Outcome Measures :
  1. Development of antibodies, cellular immunity, and cytokines before and after vaccination [ Time Frame: Up to week 6 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Relatively healthy people over age 60 who have not had Zostavax previously.

Inclusion Criteria:

  • Relatively healthy and over 60 years old

Exclusion Criteria:

  • Having already received Zostavax

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01288014

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.
Principal Investigator: Anne A. Gershon, MD Columbia University

Responsible Party: Anne A. Gershon, Professor of Pediatrics, Director of the Division of Pediatric Infectious Disease, Columbia University Identifier: NCT01288014     History of Changes
Other Study ID Numbers: AAAE1779
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017

Keywords provided by Anne A. Gershon, Columbia University:
immune response
varicella zoster virus (VZV)
cytokine levels

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs