X-linked Agammaglobulinemia Clinical Trial
Official title:
Assessment of Immunogenicity of Zostavax® in Patients With Antibody Deficiency 60 Years of Age and Older
Verified date | April 2018 |
Source | University of South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility |
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 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 - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of South Florida | Saint Petersburg | Florida |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | Merck Sharp & Dohme Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine in vitro changes in T cell proliferation preceding and following vaccination with Zostavax® by measurement of lymphocyte proliferation in response to VZV antigen. | 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. | Day 0, Week 4, 3 months, 6 months | |
Secondary | 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. | 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. | Day 0, Week 4, 3 months, 6 months |
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