NCT02960399

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 31, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

October 3, 2016

Last Update Submit

May 29, 2018

Conditions

Common Variable Immune DeficiencySpecific Antibody DeficiencyX-linked Agammaglobulinemia

Outcome Measures

Primary Outcomes (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.

    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 Outcomes (1)

  • 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.

    Day 0, Week 4, 3 months, 6 months

Study Arms (2)

Antibody Deficient Patients

EXPERIMENTAL

Zostavax® vaccine administered to antibody deficient patients 60 years of age and older.

Biological: Zostavax®

Healthy Subjects

ACTIVE COMPARATOR

Zostavax® vaccine administered per standard of care to healthy adults 60 years of age and older.

Biological: Zostavax®

Interventions

Zostavax®BIOLOGICAL

Zostavax® immunization

Antibody Deficient PatientsHealthy Subjects

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not 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
  • 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.
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Conditions

Common Variable ImmunodeficiencyBruton type agammaglobulinemia

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Immunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Chickenpox VaccineHerpesvirus VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Jennifer Leiding, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2016

First Posted

November 9, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 31, 2018

Record last verified: 2018-04

Locations

US(1)