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

Varicella Zoster Vaccine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03493776
• Other study ID #: UHN-Shingrix-001
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: April 15, 2018
• Est. completion date: April 2021

Study information

• Verified date: October 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: April 2021
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Herpes Zoster
• Varicella Zoster Vaccine

Intervention

Biological:
• VZV subunit vaccine
VZV subunit vaccine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Deepali Kumar

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cellular immunity to varicella zoster induced by varicella zoster subunit 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).	4 weeks after second dose of vaccine
Secondary	Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in lung transplant recipients.	Humoral immunogenicity (increase of GMTs of anti-VZV antibodies) in lung transplant	4 weeks after second dose of vaccine
Secondary	Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in post-transplant group vs. pre-transplant group	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.	4 weeks after second dose of vaccine