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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Upton Allen, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00213304
First received: September 14, 2005
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

We hypothesize that children listed to undergo solid organ transplant will experience (at the very most) a low rate (< 5%) of serious vaccine-related adverse events within 42 days after immunization with live attenuated Oka/Merck varicella vaccine (VARIVAX™). We also hypothesize that the immunogenicity of two doses of VARIVAX™ in the study population will be similar to historical data in healthy subjects and that the efficacy of two doses of the vaccine in the study population will be similar to that of healthy subjects.


Condition Intervention Phase
Organ Transplantation
Immunosuppression
Biological: varicella vaccine (VARIVAX)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Immunogenicity of Live Attenuated Oka/Merck Varicella Vaccine in Children Listed to Undergo Solid Organ Transplantation

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Determination of the safety of VARIVAX™ administrated as two-dose regimen to the study population
  • Determination of the proportion of study subjects immunized who demonstrate seroconversion and maintain humoral immunity seroconversion at 6, 12 and 24 months post-transplantation
  • Determination of the extent to which cellular immune responses are maintained at 6, 12 and 24 months post-transplantation

Secondary Outcome Measures:
  • The efficacy of VARIVAX™ as indicated by the incidence of clinical varicella or zoster over the 2 years following immunization

Estimated Enrollment: 150
Study Start Date: June 1999
  Eligibility

Ages Eligible for Study:   9 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00213304

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Upton Allen, MD The Hospital for Sick Children, Toronto Canada
Study Chair: Upton Allen The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Upton Allen, Chief, Division of Infectious Diseases, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00213304     History of Changes
Other Study ID Numbers: 0019990029
Study First Received: September 14, 2005
Last Updated: August 15, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
organ transplantation
immunosuppression
vaccine
varicella
pediatrics

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 28, 2014