Overview

This trial is active, not recruiting.

Conditions organ transplantation, immunosuppression
Treatment varicella vaccine (varivax)
Phase phase 3
Sponsor The Hospital for Sick Children
Start date June 1999
Trial size 150 participants
Trial identifier NCT00213304, 0019990029

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

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

Secondary Outcomes

Measure
The efficacy of VARIVAX™ as indicated by the incidence of clinical varicella or zoster over the 2 years following immunization
time frame:

Eligibility Criteria

Male or female participants from 9 months up to 18 years old.

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.

Additional Information

Official title Safety and Immunogenicity of Live Attenuated Oka/Merck Varicella Vaccine in Children Listed to Undergo Solid Organ Transplantation
Principal investigator Upton Allen, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by The Hospital for Sick Children.