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

Varicella Zoster Vaccine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03685682
• Other study ID #: UHNTID007
• Status: Completed
• Phase: Phase 3
• Start date: May 25, 2018
• Est. completion date: September 5, 2019

Study information

• Verified date: August 2020
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 5, 2019
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Herpes Zoster
• Varicella Zoster Vaccine

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network, Toronto General Hospital, Multi-Organ Transplant	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Humoral immunity to varicella zoster induced by the recombinant subunit Herpes zoster vaccine.	Fold increase in concentration of anti-gE antibody titer from pre- to post-vaccination	4 weeks after second dose of vaccine
Secondary	Rate of Vaccine-related Adverse Events	Adverse events will be graded as mild, moderate, severe	Up to 4 weeks after second dose of vaccine