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Recombinant Subunit Herpes Zoster Vaccine in VZV-Seronegative Organ Transplant Recipients

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ClinicalTrials.gov Identifier: NCT03685682
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : September 26, 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 in VZV-seronegative solid organ transplant recipients. VZV-seronegative patients will be enrolled after organ transplantation. The investigators hypothesize that the recombinant subunit Herpes zoster vaccine is able to induce cellular immunogenicity after transplantation in VZV-seronegative patients.

Condition or disease Intervention/treatment Phase
Varicella Zoster Vaccine Biological: recombinant subunit Herpes zoster vaccine Phase 3

Detailed Description:
Solid organ transplant recipients receive lifelong immunosuppression and are at increased risk for severe primary VZV infection (chickenpox) and VZV reactivation (shingles). A non-live, recombinant subunit Herpes zoster vaccine (Shingrix; GSK vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older and was shown to induce both cellular and humoral immunity. As both components of the immune system are important for protection against VZV, the investigators plan to study the humoral and cellular immunogenicity of the vaccine after organ transplantation in VZV-seronegative patients. Indeed, the current live VZV vaccine is contraindicated after transplantation; therefore, the non-live recombinant varicella-zoster subunit vaccine, if shown to induce cellular and humoral immunity, could potentially be offered to VZV-seronegative transplant patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine in VZV-seronegative Solid Organ Transplant Recipients
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : September 5, 2019
Estimated Study Completion Date : March 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: VZV seronegative Transplant Patients
recombinant subunit Herpes zoster vaccine
Biological: recombinant subunit Herpes zoster vaccine
Seronegative Solid Organ Transplant patients will receive two doses of the subunit Herpes zoster vaccine at 0 and 2-6 months




Primary Outcome Measures :
  1. Humoral immunity to varicella zoster induced by the recombinant subunit Herpes zoster vaccine. [ Time Frame: 4 weeks after second dose of vaccine ]
    Fold increase in concentration of anti-gE antibody titer from pre- to post-vaccination


Secondary Outcome Measures :
  1. Rate of Vaccine-related Adverse Events [ Time Frame: Up to 4 weeks after second dose of vaccine ]
    Adverse events will be graded as mild, moderate, severe



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Solid organ transplant recipient.
  • Age ≥18 years
  • VZV-seronegative at time of transplant
  • ≥90 days post-transplant
  • Able to provide informed consent

Exclusion Criteria:

  • Has already received the recombinant subunit Herpes zoster vaccine in the past
  • Ongoing CMV viremia > 200 IU/mL
  • HIV infection
  • Diagnosis of malignancy (e.g. PTLD)
  • History of a severe allergic reaction (anaphylactic reaction) after any vaccine
  • Documented Chickenpox or Shingles after transplantation
  • Congenital immunodeficiency (e.g., CVID)
  • Treatment for rejection in the past 30 days
  • Immunoglobulin in the past 30 days or anticipated to receive immunoglobulin
  • Anti-CD20 monoclonal antibody in the past 6 months or anticipated to receive Anti-CD20 monoclonal antibody
  • Plasmapheresis in the past 30 days or anticipated to receive plasmapheresis
  • Febrile illness in the past one week
  • Unable to comply with the study protocol

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): NCT03685682


Contacts
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Contact: Deepali Kumar, MD 4163404241 deepali.kumar@uhn.ca

Locations
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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
University Health Network, Toronto
Investigators
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Principal Investigator: Deepali Kumar, MD Multi organ transplant program, University Health Network, Toronto

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Responsible Party: Deepali Kumar, Principal Investigator, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03685682     History of Changes
Other Study ID Numbers: UHNTID007
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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