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

The Hospital for Sick Children

Status and phase

Completed

Phase 3

Conditions

Organ Transplantation

Immunosuppression

Treatments

Biological: varicella vaccine (VARIVAX)

Study type

Interventional

Funder types

Other

Identifiers

NCT00213304

0019990029

Details and patient eligibility

About

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

Enrollment

21 patients

Sex

All

Ages

9 months to 18 years old

Volunteers

No 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:
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.