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

Immunity; Defect Due to Antibody or Cell Mediated Immune Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288014
• Other study ID #: AAAE1779
• Status: Completed
• Phase: N/A
• First received: January 31, 2011
• Last updated: July 18, 2017
• Start date: January 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2017
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• Relatively healthy and over 60 years old

Exclusion Criteria:

• Having already received Zostavax

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Immunity; Defect Due to Antibody or Cell Mediated Immune Defect

Locations

Country	Name	City	State
United States	Vanderbilt Clinic, Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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