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

NCT00213304 | Completed Phase 3

• 1 other identifier: 0019990029
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Organ Transplantation; Immunosuppression

Keywords

organ transplantation; immunosuppression; vaccine; varicella; pediatrics

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

Study Arms (1)

varicella vaccine (VARIVAX)

EXPERIMENTAL

varicella vaccine (VARIVAX)

Biological: varicella vaccine (VARIVAX)

Interventions

varicella vaccine (VARIVAX) BIOLOGICAL

varicella vaccine (VARIVAX)

Eligibility Criteria

• Age: 9 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children \> 9 months of age and adolescents \< 18 years of age.
• Pediatric transplant candidates who are in any of the following categories:
• listed to receive kidney, liver, heart, lung or other or solid organ transplantation in a Canadian transplant centre
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Chickenpox

Interventions

Chickenpox Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Upton Allen, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

• Upton Allen

  The Hospital for Sick Children

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Infectious Diseases

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: June 1, 1999
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

CA (1)