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

NCT ID: NCT01288014

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-03-31

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.

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.

Conditions

Immunity; Defect Due to Antibody or Cell Mediated Immune Defect

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Relatively healthy and over 60 years old

Exclusion Criteria

• Having already received Zostavax

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Anne A. Gershon

Professor of Pediatrics, Director of the Division of Pediatric Infectious Disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne A. Gershon, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Vanderbilt Clinic, Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAE1779

Identifier Type: -

Identifier Source: org_study_id