Assessment of Immunogenicity of Zostavax® in Patients With Antibody Deficiency 60 Years of Age and Older
Stopped early · Not applicable
Conditions studied: Common Variable Immune Deficiency, Specific Antibody Deficiency, X-linked Agammaglobulinemia
In brief
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.
Key facts
- Study ID
- NCT02960399
- Run by
- University of South Florida
- People needed
- 2
- Starts
- 2015-12-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2018-05-31
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 the investigator would interfere with the conduct of the study
- Subjects unlikely to adhere to protocol follow-up
- Inclusion/Exclusion Criteria for Healthy Subjects
- Inclusion Criteria
- Adults 60 years of age and older
- 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)
- Evidence of acute systemic illness or infection at within four weeks of screening or enrollment
- Prior herpes zoster infection
Where it is running
- University of South Florida — St. Petersburg, Florida, United States
Full record on ClinicalTrials.gov
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