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

Safety and Immunogenicity of Live Attenuated Oka/Merck Varicella Vaccine in Children Listed to Undergo Solid Organ Transplantation

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

Study Overview

• Status: Completed
• Conditions: Organ Transplantation; Immunosuppression
• Intervention / Treatment: Biological: varicella vaccine (VARIVAX)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: varicella vaccine (VARIVAX)	Biological: varicella vaccine (VARIVAX)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 1999
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 14, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: pediatrics; immunosuppression; vaccine; varicella; organ transplantation
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Chickenpox
• Other Study ID Numbers: 0019990029