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The Safety of Oka Varicella in Children Prior to Solid Organ Transplantation

Primary Purpose

Organ Transplantation, Immunosuppression

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
varicella vaccine (VARIVAX)
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Organ Transplantation focused on measuring organ transplantation, immunosuppression, vaccine, varicella, pediatrics

Eligibility Criteria

9 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children > 9 months of age and adolescents < 18 years of age. Pediatric transplant candidates who are in any of the following categories: listed to receive kidney, liver, heart, lung or other or solid organ transplantation in a Canadian transplant centre not yet officially listed, but are regarded by their physicians as transplant candidates by virtue of their underlying diseases No clinical history for varicella. Seronegative for antibodies to VZV except infants 9 - 12 months of age who may be seropositive due to maternal antibodies. Informed consent obtained Exclusion Criteria: Previous immunization with varicella vaccine. Any established immune deficiency (underlying disease or drug induced) or any neoplastic disease Children on any oral and / or intravenous steroids within 3 months prior to immunization. Children on inhaled corticosteroids in excess of 800 mcg of beclomethasone dipropionate ( or equivalent ) per day. Any exposure to varicella or herpes zoster in the previous 4 weeks involving household, playmate or hospital contacts. Inability to delay the transplantation for up to 6 weeks following the last varicella immunization. Presence of a person at increased risk for varicella infection in direct and unavoidable proximity with the vaccinees ( e.g. an immunocompromised sibling) Past history of varicella or known positive antibody titer for varicella except infants 9 - 12 months of ages who may be seropositive due to maternal antibodies Known hypersensitivity to any of the components of the vaccine, including neomycin and gelatin Patients whose mothers are known to be seronegative and plan to become pregnant in the subsequent three months Administration of VZIG or any other blood products in the previous six weeks (packed red blood cells excepted). Any significant infection and/or fever at the time of vaccination Any patient receiving or planning to receive salicylates in the six weeks after immunization Any patient who has received any live vaccine for 6 weeks or killed vaccine for 2 weeks prior to or after the scheduled VARIVAX™ vaccination.

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

varicella vaccine (VARIVAX)

Arm Description

varicella vaccine (VARIVAX)

Outcomes

Primary Outcome Measures

Determination of the safety of VARIVAX™
Eligible subjects given a two-dose OMVV pre transplantation were monitored for Adverse Events. AE were monitored for up to six wk after each dose with the assistance of parent diaries.
Determination of the safety of VARIVAX™
All transplant recipients were monitored over the follow-up period for microbiological and clinical evidence of reactivation of other herpes group viruses.
Determination of the proportion immunized who demonstrate seroconversion and maintain humoral immunity seroconversion at 6, 12 and 24 months post-transplantation
Control antigen was prepared in parallel from uninfected cells. A gpELISA antibody level of >0.6 gpEU/mL defined seroconversion, and a gpELISA antibody level exceeding 5 gpEU/mL defined seroprotection.
Determination of the proportion immunized who demonstrate seroconversion and maintain humoral immunity seroconversion at 6, and 12 months post-transplantation
VZV-specific antibodies were measured at Merck Research Laboratories using a previously validated ELISA method that detected antibodies to VZV glycoproteins purified from VZV-infected human fibroblasts.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2005
Last Updated
August 18, 2021
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT00213304
Brief Title
The Safety of Oka Varicella in Children Prior to Solid Organ Transplantation
Official Title
Safety and Immunogenicity of Live Attenuated Oka/Merck Varicella Vaccine in Children Listed to Undergo Solid Organ Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 1999 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

5. Study Description

Brief Summary
This study sought to determine the safety of the varicella vaccine pre- and post-transplantation when given to pediatric patients listed for solid organ transplantation. The study assessed the antibody response to a two-dose vaccine regimen and determined the durability of that antibody response at several intervals in the post-transplant period. As a secondary objective, the relationship between antibody titers and different variables were explored

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Organ Transplantation, Immunosuppression
Keywords
organ transplantation, immunosuppression, vaccine, varicella, pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
varicella vaccine (VARIVAX)
Arm Type
Experimental
Arm Description
varicella vaccine (VARIVAX)
Intervention Type
Biological
Intervention Name(s)
varicella vaccine (VARIVAX)
Primary Outcome Measure Information:
Title
Determination of the safety of VARIVAX™
Description
Eligible subjects given a two-dose OMVV pre transplantation were monitored for Adverse Events. AE were monitored for up to six wk after each dose with the assistance of parent diaries.
Time Frame
Up to 6 months
Title
Determination of the safety of VARIVAX™
Description
All transplant recipients were monitored over the follow-up period for microbiological and clinical evidence of reactivation of other herpes group viruses.
Time Frame
up to 6 months
Title
Determination of the proportion immunized who demonstrate seroconversion and maintain humoral immunity seroconversion at 6, 12 and 24 months post-transplantation
Description
Control antigen was prepared in parallel from uninfected cells. A gpELISA antibody level of >0.6 gpEU/mL defined seroconversion, and a gpELISA antibody level exceeding 5 gpEU/mL defined seroprotection.
Time Frame
up to 12 months
Title
Determination of the proportion immunized who demonstrate seroconversion and maintain humoral immunity seroconversion at 6, and 12 months post-transplantation
Description
VZV-specific antibodies were measured at Merck Research Laboratories using a previously validated ELISA method that detected antibodies to VZV glycoproteins purified from VZV-infected human fibroblasts.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children > 9 months of age and adolescents < 18 years of age. Pediatric transplant candidates who are in any of the following categories: listed to receive kidney, liver, heart, lung or other or solid organ transplantation in a Canadian transplant centre not yet officially listed, but are regarded by their physicians as transplant candidates by virtue of their underlying diseases No clinical history for varicella. Seronegative for antibodies to VZV except infants 9 - 12 months of age who may be seropositive due to maternal antibodies. Informed consent obtained Exclusion Criteria: Previous immunization with varicella vaccine. Any established immune deficiency (underlying disease or drug induced) or any neoplastic disease Children on any oral and / or intravenous steroids within 3 months prior to immunization. Children on inhaled corticosteroids in excess of 800 mcg of beclomethasone dipropionate ( or equivalent ) per day. Any exposure to varicella or herpes zoster in the previous 4 weeks involving household, playmate or hospital contacts. Inability to delay the transplantation for up to 6 weeks following the last varicella immunization. Presence of a person at increased risk for varicella infection in direct and unavoidable proximity with the vaccinees ( e.g. an immunocompromised sibling) Past history of varicella or known positive antibody titer for varicella except infants 9 - 12 months of ages who may be seropositive due to maternal antibodies Known hypersensitivity to any of the components of the vaccine, including neomycin and gelatin Patients whose mothers are known to be seronegative and plan to become pregnant in the subsequent three months Administration of VZIG or any other blood products in the previous six weeks (packed red blood cells excepted). Any significant infection and/or fever at the time of vaccination Any patient receiving or planning to receive salicylates in the six weeks after immunization Any patient who has received any live vaccine for 6 weeks or killed vaccine for 2 weeks prior to or after the scheduled VARIVAX™ vaccination.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Upton Allen, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Upton Allen
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Study Chair
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

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The Safety of Oka Varicella in Children Prior to Solid Organ Transplantation

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