An interventional study of Zostavax® in Common Variable Immune Deficiency, Specific Antibody Deficiency and X-linked Agammaglobulinemia, sponsored by University of South Florida. Terminated at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-31.
Sponsored by University of South Florida · Not applicable, Interventional, and Prevention
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.
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 (PHN).
Recommendations on the prevention of herpes zoster published in the Morbidity and Mortality Weekly Report (MMWR) by the Centers for disease control (CDC) in May 2008 make the following statements:
Zoster vaccine should not be administered to persons with primary or acquired immunodeficiency including:
a. Persons with clinical or laboratory evidence of other unspecified cellular immunodeficiency.
The investigators hypothesize that vaccination with Zostavax® in adults with CVID, SAD, and XLA who have evidence of normal cell mediated immunity with normal T cell quantities and function will have a boost in VZV-CMI thereby reducing susceptibility to shingles and PHN.
Successful completion of this study will provide clinical immunologists with data upon which to advise antibody deficient patients concerning the use of Zostavax®.
54 studies on the registry are indexed under Common Variable Immunodeficiency; 13 are open to participants now.
This study's enrollment of 2 is below the median of 40 across 39 interventional studies indexed under Common Variable Immunodeficiency.
Browse Common Variable Immunodeficiency studies →University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion/Exclusion Criteria for Antibody Deficient Patients
Inclusion Criteria
Exclusion Criteria
Inclusion/Exclusion Criteria for Healthy Subjects
Inclusion Criteria
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Zostavax® vaccine administered to antibody deficient patients 60 years of age and older.
Biological: Zostavax®
Zostavax® vaccine administered per standard of care to healthy adults 60 years of age and older.
Biological: Zostavax®
Zostavax® immunization
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.
Time frame: Day 0, Week 4, 3 months, 6 months
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.
Time frame: Day 0, Week 4, 3 months, 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Dec 2015, a primary completion of Dec 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Chickenpox Vaccine
Common Variable Immunodeficiency →