Clinical Trial: Assessment of Immunogenicity of Zostavax® in Patients With Antibody Deficiency 60 Years of Age and Older

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Assessment of Immunogenicity of Zostavax® in Patients With Antibody Deficiency 60 Years of Age and Older

Brief Summary: Recommendations concerning the administration of Zostavax® in patients with antibody deficiency are unclear. The investigators plan to assess the immunogenicity and safety of Zostavax® in patients with antibody deficiency as compared with healthy volunteers.

Detailed Summary:

Common variable immune deficiency (CVID), specific antibody deficiency (SAD), and X-linked agammaglobulinemia (XLA) are among the most common primary antibody deficiencies in which the mainstay of treatment is gammaglobulin replacement. The use of high doses of immunoglobulin replacement therapy and the early recognition of co-morbid diseases during the course of CVID, SAD, and XLA has improved survival and led to an aging population of CVID, SAD, and XLA patients.

The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of all persons aged >60 years with 1 dose of vaccine directed against herpes zoster (Zostavax®) in the absence of any contraindications. Current standard of care includes avoidance of all vaccines when receiving gammaglobulin products due to passive immunity obtained from gammaglobulin against vaccine preventable infections. The exception to this rule is that patients on gammaglobulin should receive the yearly influenza vaccine due to its enhanced cell mediated immunity against the influenza virus. Clinical immunologists currently have no data upon which to advise patients receiving gammaglobulin replacement including those with CVID, SAD, and XLA concerning use of Zostavax®.

All gammaglobulin replacement products maintain protective antibody levels against VZV. However, humoral immune responses with anti-VZV antibodies are relatively constant and do not protect against the development of shingles. Varicella zoster virus specific cell mediated immunity (VZV-CMI), which is T cell dependent, is the critical component in preventing herpes zoster (shingles). VZV-CMI diminishes with age leaving the elderly most susceptible to shingles. Several studies have concluded that boosting VZV-CMI protects older adults from developing herpes zoster and postherpetic neuralgia (PH
Sponsor: University of South Florida

Current Primary Outcome: Determine in vitro changes in T cell proliferation preceding and following vaccination with Zostavax® by measurement of lymphocyte proliferation in response to VZV antigen. [ Time Frame: Day 0, Week 4, 3 months, 6 months ]

Determine in vitro lymphocyte proliferation as counts per minute after stimulation of cells with varicella zoster antigen at time points preceding and following vaccination with Zostavax. Blood samples will be obtained prior to administering the Zostavax® vaccine and post-vaccination at 4 weeks, 3 months, and 6 months.


Original Primary Outcome: Same as current

Current Secondary Outcome: Determine in vitro changes in T cell proliferation preceding and following vaccination with Zostavax® by measurement of IFNg production by T cells in response to VZV antigen. [ Time Frame: Day 0, Week 4, 3 months, 6 months ]

Determine in vitro IFNg production as Units/ml after stimulation of cells with varicella zoster antigen at time points preceding and following vaccination with Zostavax. Blood samples will be obtained prior to administering the Zostavax® vaccine and post-vaccination at 4 weeks, 3 months, and 6 months.


Original Secondary Outcome: Same as current

Information By: University of South Florida

Dates:
Date Received: October 3, 2016
Date Started: December 2015
Date Completion: December 2019
Last Updated: November 7, 2016
Last Verified: September 2016