Assessment of Immunogenicity of Zostavax® in Patients With Antibody Deficiency 60 Years of Age an… (NCT02960399) | Clinical Trial Compass
TerminatedNot Applicable
Assessment of Immunogenicity of Zostavax® in Patients With Antibody Deficiency 60 Years of Age and Older
Stopped: PI has terminated the study at this time.
United States2 participantsStarted 2015-12
Plain-language 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.
Who can participate
Age range60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion/Exclusion Criteria for Antibody Deficient Patients
Inclusion Criteria
* Adults 60 years of age and older
* Diagnosis of common variable immunodeficiency (CVID), Specific Antibody Deficiency (SAD), or X-linked agammaglobulinemia (XLA)
* Receiving replacement gammaglobulin
* Willing and able to sign consent and follow study schedule
* History of varicella or long-term (greater than or equal to 30 years) residence in the USA
Exclusion Criteria
* Allergy to Zostavax® or any of its components (i.e gelatin, neomycin)
* Absolute CD3, CD4, or CD8 lymphopenia as determined by age specific reference ranges
* Poor T cell function as indicated by a \< 30 % increase in T cell response to mitogens or antigens as compared to the age matched normal reference range (in CVID) subjects
* Evidence of acute systemic illness or infection at within four weeks of screening or enrollment
* Prior herpes zoster infection
* Previously received herpes zoster vaccination
* Malignancy including solid tumors, leukemia, or lymphoma
* Presence of autoimmune or other inflammatory disease
* Use of immunosuppressive or immunomodulatory medications including chronic corticosteroids. Treatment for \>2weeks of daily steroids will be considered chronic use.
* History of bleeding or chronic skin disorders.
* Pregnant or breastfeeding females
* Immunizations within one month
* Persons with HIV or AIDS
* Subject unwilling to sign consent or adhere to study schedule
* Any condition that in the opinion of t…
What they're measuring
1
Determine in vitro changes in T cell proliferation preceding and following vaccination with Zostavax® by measurement of lymphocyte proliferation in response to VZV antigen.