Cytokine Production and Immunity 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.

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Key information

Conditions

Immunity; Defect Due to Antibody or Cell Mediated Immune Defect Chickenpox DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt Clinic, Columbia University Medical Center

New York, 10128, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Relatively healthy and over 60 years old

Exclusion criteria

Having already received Zostavax

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Feb 2, 2011
Registry last updated: Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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