Immunosuppression Clinical Trial
Official title:
Safety and Immunogenicity of Live Attenuated Oka/Merck Varicella Vaccine in Children Listed to Undergo Solid Organ Transplantation
NCT number | NCT00213304 |
Other study ID # | 0019990029 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | June 1999 |
Est. completion date | December 2016 |
Verified date | August 2021 |
Source | The Hospital for Sick Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 21 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 9 Months to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | The Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to 6 months | |
Primary | 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. | up to 6 months | |
Primary | 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. | up to 12 months | |
Primary | 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. | Up to 12 months |
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