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Trial record 21 of 465 for:    Shingles

Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation

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ClinicalTrials.gov Identifier: NCT03493776
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Deepali Kumar, University Health Network, Toronto

Brief Summary:
The investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. Patients (at least 50 years old) before and after lung transplantation will be enrolled. The investigators hypothesize that the recombinant varicella-zoster subunit vaccine is able to induce cellular immunogenicity after transplantation.

Condition or disease Intervention/treatment Phase
Varicella Zoster Vaccine Biological: VZV subunit vaccine Phase 4

Detailed Description:
Solid organ transplant recipients receive lifelong immunosuppression and are at increased risk for reactivation of all herpesviruses including VZV. Epidemiologic studies show the cumulative incidence in lung transplant recipients of reactivation to be 15-20%. A non-live, recombinant subunit vaccine (Shingrix; GSK vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older. The investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. Patients (at least 50 years old) before and after lung transplantation will be enrolled. The investigators hypothesize that the recombinant varicella-zoster subunit vaccine is able to induce cellular immunogenicity after transplantation.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : September 5, 2019
Estimated Study Completion Date : March 5, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pre-Transplant Group
VZV Subunit vaccine will be administered
Biological: VZV subunit vaccine
VZV subunit vaccine

Experimental: Post-Transplant Group
VZV Subunit vaccine will be administered
Biological: VZV subunit vaccine
VZV subunit vaccine




Primary Outcome Measures :
  1. Cellular immunity to varicella zoster induced by varicella zoster subunit vaccine. [ Time Frame: 4 weeks after second dose of vaccine ]
    Cellular immunogenicity against VZV induced by varicella zoster subunit vaccine in lung transplant recipients measured as a percentage of CD4+ and CD8+ T-cells measured by intracellular flow-cytometry based staining. The cellular immunogenicity of the vaccine in lung transplant recipients will be compared to the control group (pre-transplant vaccination).


Secondary Outcome Measures :
  1. Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in lung transplant recipients. [ Time Frame: 4 weeks after second dose of vaccine ]
    Humoral immunogenicity (increase of GMTs of anti-VZV antibodies) in lung transplant

  2. Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in post-transplant group vs. pre-transplant group [ Time Frame: 4 weeks after second dose of vaccine ]
    Humoral immunogenicity (GMTs of anti-VZV antibodies compared pre and post vaccination) against VZV induced by varicella zoster subunit vaccine in lung transplant recipients compared to the pre-transplant control group.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria Post-Transplant Vaccine Group:

  • Single or double lung transplant recipient.
  • Age ≥50 years

Exclusion Criteria Post-Transplant Vaccine Group:

  • Has already received varicella zoster subunit vaccine in the past
  • Shingles within the last 12 months
  • Ongoing CMV viremia > 200 IU/mL
  • HIV infection
  • Diagnosis of malignancy (eg PTLD)

Inclusion Criteria Pre-Transplant Vaccine Group:

  • On waiting list for lung transplantation
  • Age ≥50 years

Exclusion Criteria Pre-Transplant Vaccine Group:

  • Has already received Shingrix or Zostavax (live shingles vaccine) in the past
  • Systemic prednisone ≥20 mg per day (or equivalent dose of any corticosteroid)
  • Other (than prednisone < 20mg per day or equivalent dose of any corticosteroid) systemic immunosuppressive therapy such as mycophenolate or tacrolimus
  • Shingles within the last 12 months
  • HIV infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493776


Contacts
Contact: Deepali Kumar, MD +1 416 340 ext 4241 deepali.kumar@uhn.ca

Locations
Canada, Ontario
University Health Network, Toronto General Hospital, Multi-Organ Transplant Recruiting
Toronto, Ontario, Canada, M5G2N2
Contact: Deepali Kumar, MD    +1 416 340 4800 ext 4241    deepali.kumar@uhn.ca   
Sponsors and Collaborators
Deepali Kumar
Investigators
Principal Investigator: Deepali Kumar, MD Multi organ transplant program, University Health Network, Toronto

Responsible Party: Deepali Kumar, MD, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03493776     History of Changes
Other Study ID Numbers: UHN-Shingrix-001
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs