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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varicella vaccine (VARIVAX) | Experimental | varicella vaccine (VARIVAX) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varicella vaccine (VARIVAX) | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the safety of VARIVAXâ„¢ | 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 |
| Determination of the safety of VARIVAXâ„¢ | 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 |
| 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 |
| 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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Inclusion Criteria:
Children > 9 months of age and adolescents < 18 years of age.
Pediatric transplant candidates who are in any of the following categories:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Upton Allen, MD | The Hospital for Sick Children, Toronto Canada | Principal Investigator |
| Upton Allen | The Hospital for Sick Children | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
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| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| ID | Term |
|---|---|
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| D007239 | Infections |
| D045424 |
| Complex Mixtures |