Clinical trial NCT01288014: Cytokine Production and Immunity to Varicella Zoster Virus (VZV) in Elderly Recipients of Zoster Vaccine
Official title: Relationship of Cytokine Production and Immune Responses to Varicella Zoster Virus (VZV) in Elderly Recipients of Zoster Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunity; Defect Due to Antibody or Cell Mediated Immune Defect
Keywords: immune response
varicella zoster virus (VZV)
cytokine levels
immunization
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-02-02
Enrollment: 26
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Relatively healthy people over age 60 who have not had Zostavax previously.

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.

Eligibility criteria: Inclusion Criteria:

* Relatively healthy and over 60 years old

Exclusion Criteria:

* Having already received Zostavax

Primary outcomes:
measure: Development of antibodies, cellular immunity, and cytokines before and after vaccination
timeFrame: Up to week 6
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Vanderbilt Clinic, Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Anne A. Gershon, MD
role: PRINCIPAL_INVESTIGATOR
References: