Organ TransplantationPhase 3NCT00213304
The Safety of Oka Varicella in Children Prior to Solid Organ Transplantation
A Phase 3 study testing varicella vaccine (VARIVAX) in people with Organ Transplantation and Immunosuppression, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 months to 18 years
- Conditions the study is for
- Organ Transplantation, Immunosuppression
- What is being tested?
- varicella vaccine (VARIVAX)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Jun 1999to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Organ Transplantation, Immunosuppression
- Being tested
- varicella vaccine (VARIVAX)
- Keywords
- organ transplantation, immunosuppression, vaccine, varicella, pediatrics
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
varicella vaccine (VARIVAX)Biological
| Study group | Role | What they receive |
|---|---|---|
| varicella vaccine (VARIVAX) | Experimental | varicella vaccine (VARIVAX) Receives: Biological: varicella vaccine (VARIVAX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 1999
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ TransplantationStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Upton Allen, The Hospital for Sick Children
- Investigators
- Upton Allen, MD, Principal investigator, The Hospital for Sick Children, Toronto CanadaUpton Allen, Study chair, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213304
- Sponsor's protocol ID
- 0019990029
- Status last verified
- Aug 2021
- First submitted
- 14 Sep 2005
- Last updated
- 24 Aug 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Live Attenuated Oka/Merck Varicella Vaccine in Children Listed to Undergo Solid Organ Transplantation
- ClinicalTrials.gov ID
- NCT00213304
- Acronym / sponsor ID
- 0019990029
- Conditions
- Organ Transplantation, Immunosuppression
- Keywords
- organ transplantation, immunosuppression, vaccine, varicella, pediatrics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jun 1999 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| varicella vaccine (VARIVAX) | Experimental | Biological: varicella vaccine (VARIVAX)varicella vaccine (VARIVAX) |
Who may qualify
- Ages
- 9 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| varicella vaccine (VARIVAX) | Biological | varicella vaccine (VARIVAX) |
Primary outcome
Determination of the safety of VARIVAX™
Time frame: Up to 6 months
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.
Determination of the safety of VARIVAX™
Time frame: up to 6 months
All transplant recipients were monitored over the follow-up period for microbiological and clinical evidence of reactivation of other herpes group viruses.
Determination of the proportion immunized who demonstrate seroconversion and maintain humoral immunity seroconversion at 6, 12 and 24 months post-transplantation
Time frame: up to 12 months
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.
Determination of the proportion immunized who demonstrate seroconversion and maintain humoral immunity seroconversion at 6, and 12 months post-transplantation
Time frame: Up to 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Upton Allen, MD principal investigator
The Hospital for Sick Children, Toronto Canada
Upton Allen study chair
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing varicella vaccine (VARIVAX) in people with Organ Transplantation and Immunosuppression, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the safety of VARIVAX™ (time frame: Up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.