Skip to main content
OpenTrials
Completed

NCT Number: NCT03685682

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Health Network, Toronto General Hospital, Multi-Organ Transplant

Toronto, Ontario, M5G2N2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recombinant subunit herpes zoster vaccine

Biological

Seronegative Solid Organ Transplant patients will receive two doses of the subunit Herpes zoster vaccine at 0 and 2-6 months

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine in VZV-seronegative Solid Organ Transplant Recipients

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 26, 2018
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.