Recombinant Subunit Herpes Zoster Vaccine in VZV-Seronega... | NCT03685682

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

NCT03685682

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Aug 5, 2020Actual

Enrollment

23Actual

Phase

Phase 3

Conditions

Varicella Zoster Vaccine

Interventions

recombinant subunit Herpes zoster vaccine

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 25, 2018Actual

Primary Completion Date

Sep 5, 2019Actual

Completion Date

Sep 5, 2019Actual

First Submitted Date

Sep 23, 2018

First Submission Date that Met QC Criteria

Sep 24, 2018

First Posted Date

Sep 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2020

Last Update Posted Date

Aug 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VZV seronegative Transplant Patients	Experimental	recombinant subunit Herpes zoster vaccine	Biological: recombinant subunit Herpes zoster vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Rate of Vaccine-related Adverse Events	Adverse events will be graded as mild, moderate, severe	Up to 4 weeks after second dose of vaccine

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deepali Kumar, MD	Multi organ transplant program, University Health Network, Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Health Network, Toronto General Hospital, Multi-Organ Transplant		Toronto	Ontario	M5G2N2	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33528118	Derived	L'Huillier AG, Hirzel C, Ferreira VH, Ierullo M, Ku T, Selzner N, Schiff J, Juvet S, Miao C, Schmid DS, Humar A, Kumar D. Evaluation of Recombinant Herpes Zoster Vaccine for Primary Immunization of Varicella-seronegative Transplant Recipients. Transplantation. 2021 Oct 1;105(10):2316-2323. doi: 10.1097/TP.0000000000003621.