Clinical trial NCT00213304: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Organ Transplantation
Immunosuppression
Keywords: organ transplantation
immunosuppression
vaccine
varicella
pediatrics
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 21
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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:

  1. listed to receive kidney, liver, heart, lung or other or solid organ transplantation in a Canadian transplant centre
  2. 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.

Primary outcomes:
measure: Determination of the safety of VARIVAX™
timeFrame: Up to 6 months
measure: Determination of the safety of VARIVAX™
timeFrame: up to 6 months
measure: Determination of the proportion immunized who demonstrate seroconversion and maintain humoral immunity seroconversion at 6, 12 and 24 months post-transplantation
timeFrame: up to 12 months
measure: Determination of the proportion immunized who demonstrate seroconversion and maintain humoral immunity seroconversion at 6, and 12 months post-transplantation
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Upton Allen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Upton Allen
role: STUDY_CHAIR
References: