VaricellaNCT02692066
Response and Clearance of Viral DNA Following Administration of Live Attenuated Varicella Vaccine.
An observational study of Varicella and Transplants, run by University of Colorado, Denver.
Trial summary
Varicella zoster virus (VZV) can lead to significant morbidity and mortality in transplant recipients. Current recommendations suggest a 4 week waiting period between vaccination and transplantation and consideration of booster immunizations if antibody response does not reach target levels. Read more about this study
- Who is it for?
- Ages 6 months to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella, Transplants
- What is being tested?
- varicella vaccine
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Apr 2016
- Phase
- Observational
- 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 6 months to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children with liver disease and healthy controls who have not received varicella vaccination and who have no history of varicella or zoster
Who may be able to join
- 6 months to 21 years
- no history of varicella, zoster or prior varicella vaccination
Who cannot join
- acute liver failure
- liver transplant anticipated within 28 days
- prior history of receiving blood products or immunoglobulin within 5 months prior to vaccination
- fever
- pregnancy
- immunocompromised status
- receiving immunosuppressive meds
About this study
Official title: Response and Clearance of Viral DNA Following Administration of Live Attenuated Varicella Vaccine in Children With Liver Disease
Varicella zoster virus (VZV) can lead to significant morbidity and mortality in transplant recipients. Current recommendations suggest a 4 week waiting period between vaccination and transplantation and consideration of booster immunizations if antibody response does not reach target levels. This four week waiting period can result in delayed transplant, rejection of an optimal organ, or missed opportunity to vaccinate. However, these recommendations are not evidence based.
This is a prospective study to look at the immune response to varicella vaccine in children with chronic liver disease.
Read more
Investigators will evaluate:
- the time at which VZV DNA becomes undetectable in blood and saliva by PCR after vaccination in children with chronic liver disease and
- the difference in humoral and cell mediated immune response to varicella immunization between children with chronic liver disease and healthy children.
- Conditions
- Varicella, Transplants
- Being tested
- varicella vaccine
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
varicella vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Healthy Children ages 6 months-21 years who have not received varicella vaccine and who do not have prior varicella or zoster will receive Varivax. We will then measure 1) markers of humoral immunity at baseline and 4 weeks post vaccination and 2) markers of cell mediated immunity at baseline, 1 week, and 4 weeks post vaccination Receives: Biological: varicella vaccine | |
| Children with Chronic Liver Disease | Children with chronic liver disease ages 6 months-21 years who have not received varicella vaccine and who do not have prior varicella or zoster will receive Varivax. We will then measure 1) varicella DNA in the blood and saliva at enrollment, 1 week, 2 weeks, 3 weeks, 4 weeks post vaccination 2)markers of humoral immunity at baseline and 4 weeks post vaccination and 3) markers of cell mediated immunity at baseline, 1 week, and 4 weeks post vaccination Receives: Biological: varicella vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
clearance of viral DNA
Measured: 4 weeks
humoral response
Measured: 4 weeks
cell mediated response
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startApr 2016 (estimated)
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Why it stopped: Funding not acquired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricellaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Feldman, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692066
- Sponsor's protocol ID
- 15-2042
- Status last verified
- May 2018
- First submitted
- 19 Feb 2016
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response and Clearance of Viral DNA Following Administration of Live Attenuated Varicella Vaccine in Children With Liver Disease
- ClinicalTrials.gov ID
- NCT02692066
- Acronym / sponsor ID
- 15-2042
- Conditions
- Varicella, Transplants
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding not acquired
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Apr 2016 (estimated)
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 25 Feb 2016 (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.
Varicella zoster virus (VZV) can lead to significant morbidity and mortality in transplant recipients. Current recommendations suggest a 4 week waiting period between vaccination and transplantation and consideration of booster immunizations if antibody response does not reach target levels. This four week waiting period can result in delayed transplant, rejection of an optimal organ, or missed opportunity to vaccinate. However, these recommendations are not evidence based.
This is a prospective study to look at the immune response to varicella vaccine in children with chronic liver disease.
Investigators will evaluate:
- the time at which VZV DNA becomes undetectable in blood and saliva by PCR after vaccination in children with chronic liver disease and
- the difference in humoral and cell mediated immune response to varicella immunization between children with chronic liver disease and healthy children.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Biological: varicella vaccineHealthy Children ages 6 months-21 years who have not received varicella vaccine and who do not have prior varicella or zoster will receive Varivax. We will then measure 1) markers of humoral immunity at baseline and 4 weeks post vaccination and 2) markers of cell mediated immunity at baseline, 1 week, and 4 weeks post vaccination |
| Children with Chronic Liver Disease | – | Biological: varicella vaccineChildren with chronic liver disease ages 6 months-21 years who have not received varicella vaccine and who do not have prior varicella or zoster will receive Varivax. We will then measure 1) varicella DNA in the blood and saliva at enrollment, 1 week, 2 weeks, 3 weeks, 4 weeks post vaccination 2)markers of humoral immunity at baseline and 4 weeks post vaccination and 3) markers of cell mediated immunity at baseline, 1 week, and 4 weeks post vaccination |
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children with liver disease and healthy controls who have not received varicella vaccination and who have no history of varicella or zoster
Key inclusion criteria (2 listed)
- 6 months to 21 years
- no history of varicella, zoster or prior varicella vaccination
Key exclusion criteria (7 listed)
- acute liver failure
- liver transplant anticipated within 28 days
- prior history of receiving blood products or immunoglobulin within 5 months prior to vaccination
- fever
- pregnancy
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 | Biological | Children with Chronic Liver Disease, Healthy Controls |
Primary outcome
clearance of viral DNA
Time frame: 4 weeks
humoral response
Time frame: 4 weeks
cell mediated response
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
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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.
Amy Feldman, MD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
An observational study of Varicella and Transplants, run by University of Colorado, Denver.
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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
clearance of viral DNA (time frame: 4 weeks). The study lists 3 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 9 May 2018.