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 range
60 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.