Kidney Transplant RecipientsPhase 1NCT00005009
Evaluation of the Safety of Varivax® in Pediatric Renal Transplant Recipients
A Phase 1 study testing Varivax® in people with Kidney Transplant Recipients, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
The purpose of this study is to find out whether Varivax is safe for use in children with kidney transplants and whether it protects children from serious infection. Varivax is a vaccine against varicella zoster virus (VZV), the virus that causes chickenpox (varicella) and shingles (zoster). Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Kidney Transplant Recipients
- What is being tested?
- Varivax®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 1998to 16 Jun 2001
- Phase
- Phase 1
- 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 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Your child may be eligible for this trial if he/she:
- Had a kidney transplant 1 year ago or more;
- Is between 2 and 21 years of age (parent or guardian's signed informed consent required if under 18);
- Is taking stable, maintenance doses of immunosuppressive drugs for his/her kidney transplant; and
- Is generally in good health.
Who cannot join
- Your child will not be eligible for this trial if he/she:
- Has had any rejection episodes in the last 6 months or has other problems with their kidneys;
- Was in the hospital for a major infection in the last 30 days;
- Has a history of VZV infection, including chicken pox or shingles;
- Has ever received a VZV vaccine, including Varivax®;
- Lives with a person whose immune system does not work well;
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- Is allergic to certain medications;
- Is unable to return for the prescribed follow-up check-ups;
- Has no phone or pager; or
- Has had blood or plasma transfusions or taken certain drugs in the last 6 months.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan - Vaccine and Treatment Evaluation Unit (VTEU)
Ann Arbor, Michigan, 48103
University of Alabama at Birmingham - Vaccine and Treatment Evaluation Unit (VTEU)
Birmingham, Alabama, 35401
Boston Children's Hospital - Vaccine and Treatment Evaluation Unit (VTEU)
Boston, Massachusetts, 02115
University of Texas Health Science Center at San Antonio - Vaccine and Treatment Evaluation Unit (VTEU)
San Antonio, Texas, 78229
About this study
Official title: Evaluation of the Safety and Immunogenicity of Varivax® (Live-Attenuated Varicella-Zoster Virus Vaccine) in Pediatric Renal Transplant Recipients
The purpose of this study is to find out whether Varivax is safe for use in children with kidney transplants and whether it protects children from serious infection. Varivax is a vaccine against varicella zoster virus (VZV), the virus that causes chickenpox (varicella) and shingles (zoster).
Healthy children are already receiving Varivax shots to protect them from chickenpox. Few children with kidney transplants have received Varivax because doctors have been concerned that Varivax might cause serious reactions in them. On the other hand, VZV infection can be a life-threatening disease in these children. For this reason, doctors ultimately want to learn whether Varivax might safely prevent VZV infections in children who have had kidney transplants.
Read the detailed description
Pediatric renal transplant patients face a lifetime of immunosuppressive therapy that place them at high risk for potentially life-threatening infection by primary varicella zoster virus (VZV). Treatment for acute episodes of VZV infection is possible but expensive and provides no long-term protection. Furthermore, therapy to overcome VZV infections can lead to renal graft rejection.
Varivax has proven safe, immunogenic, and effective in the normal host and has been recommended for universal administration in the general population at age 12 months. It is not currently labeled for use in immunocompromised patients. However, recent studies in pediatric leukemia and pediatric renal transplant patients suggest that attenuated live vaccine can confer protection with minimal adverse events even in the presence of immunosuppression, providing encouragement for more careful studies of VZV immunization in renal transplant patients. This study aims to quantify the safety and immunogenicity of Varivax in the population of pediatric renal transplant patients least susceptible to VZV infection, i.e., those on minimal maintenance immunosuppression and at least 1 year out from transplant.
Patient enrollment is staged to allow study physicians to closely monitor patients for signs of disseminated varicella reactions or graft rejection. Initially only 1 patient will be enrolled in the study. If the first patient reaches Week 8 without a severe adverse reaction, 3 study centers will then enroll 3 additional patients. If 8 weeks later these 3 patients have had no severe adverse reactions, the same 3 study centers will enroll 3 more patients. At the end of this period, having ascertained the safety of the vaccine in the first 7 patients, the study will be opened to the remaining centers. Patients receive 2 doses of Varivax 6 to 8 weeks apart. Each week for 6 to 8 weeks after the first vaccine dose, the patient undergoes venipuncture and clinical assessment to characterize renal graft and liver function and identify any signs of varicella infection. Additional telephone follow-up occurs on Day 4 and twice weekly thereafter. Parents or guardians monitor the patient for evidence of rash or fever and immediately report any rashes or fevers to study physicians. If, after 6 to 8 weeks, the patient demonstrates no severe reactions to the vaccine and requires no antiviral therapy, the patient receives the second vaccine dose. The patient again receives weekly on-site and telephone follow-up for 6 weeks. Other visits occur 9 weeks and 14 weeks after the second vaccine dose and 1 year after the first vaccine dose. At these visits the patient undergoes venipuncture and clinical assessment to identify potential rejection events or varicella infection and to characterize VZV antibody responses and cytokine changes in response to the vaccine.
- Conditions
- Kidney Transplant Recipients
- Being tested
- Varivax®
- Keywords
- pediatric renal transplant recipients, varicella zoster virus (VZV) vaccine, herpes zoster vaccine, VZV susceptible, safety, immunogenicity
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varivax®Biological
Also called live-attenuated varicella zoster virus vaccine, varicella zoster virus vaccine, Oka-Merck live virus vaccine
Each participant will receive 2 doses of Varivax 6 to 8 weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| Varivax® | Experimental | 0.5 mL of Varivax administered subcutaneously in the right upper arm (deltoid region). Receives: Biological: Varivax® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate adverse reactions
Measured: 30 minutes post vaccination
Varicella related adverse reactions
- Fever and local (<1 inch from inoculation site) lesions
- Fever and lesions outside the 1 inch inoculation site
- Lesions outside the 1 inch inoculation site
- Clinical signs of pneumonitis
- Clinical or chemical signs of hepatitis
- Development of thrombocytopenia
Measured: 1 year
Rejection events
- Increase in creatinine
- Renal biopsy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startFeb 1998
- Primary completion16 Jun 2001
- Study completion16 Jun 2001
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Merck Sharp & Dohme LLC, Cooperative Clinical Trials in Pediatric Transplantation, North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS), NIAID Vaccine and Treatment Evaluation Units (VTEUs)
- Responsible party
- Sponsor
- Investigators
- Amir Tejani, MD, Study chair, North American Pediatric Renal Transplantation Study (NAPRTCS)Beverly L. Connelly, MD, Study chair, Vaccine and Treatment Evaluation Unit (VTEU)-Cincinnati Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005009
- Sponsor's protocol ID
- DAIT VZV
- Status last verified
- Feb 2017
- First submitted
- 28 Mar 2000
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Immunogenicity of Varivax® (Live-Attenuated Varicella-Zoster Virus Vaccine) in Pediatric Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT00005009
- Acronym / sponsor ID
- DAIT VZV
- Conditions
- Kidney Transplant Recipients
- Keywords
- pediatric renal transplant recipients, varicella zoster virus (VZV) vaccine, herpes zoster vaccine, VZV susceptible, safety, immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Merck Sharp & Dohme LLC, Cooperative Clinical Trials in Pediatric Transplantation, North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS), NIAID Vaccine and Treatment Evaluation Units (VTEUs)
- Study start
- Feb 1998
- Primary completion
- 16 Jun 2001 (actual)
- Study completion
- 16 Jun 2001 (actual)
- First posted
- 31 Aug 2001 (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.
The purpose of this study is to find out whether Varivax is safe for use in children with kidney transplants and whether it protects children from serious infection. Varivax is a vaccine against varicella zoster virus (VZV), the virus that causes chickenpox (varicella) and shingles (zoster).
Healthy children are already receiving Varivax shots to protect them from chickenpox. Few children with kidney transplants have received Varivax because doctors have been concerned that Varivax might cause serious reactions in them. On the other hand, VZV infection can be a life-threatening disease in these children. For this reason, doctors ultimately want to learn whether Varivax might safely prevent VZV infections in children who have had kidney transplants.
Detailed description
Pediatric renal transplant patients face a lifetime of immunosuppressive therapy that place them at high risk for potentially life-threatening infection by primary varicella zoster virus (VZV). Treatment for acute episodes of VZV infection is possible but expensive and provides no long-term protection. Furthermore, therapy to overcome VZV infections can lead to renal graft rejection.
Varivax has proven safe, immunogenic, and effective in the normal host and has been recommended for universal administration in the general population at age 12 months. It is not currently labeled for use in immunocompromised patients. However, recent studies in pediatric leukemia and pediatric renal transplant patients suggest that attenuated live vaccine can confer protection with minimal adverse events even in the presence of immunosuppression, providing encouragement for more careful studies of VZV immunization in renal transplant patients. This study aims to quantify the safety and immunogenicity of Varivax in the population of pediatric renal transplant patients least susceptible to VZV infection, i.e., those on minimal maintenance immunosuppression and at least 1 year out from transplant.
Patient enrollment is staged to allow study physicians to closely monitor patients for signs of disseminated varicella reactions or graft rejection. Initially only 1 patient will be enrolled in the study. If the first patient reaches Week 8 without a severe adverse reaction, 3 study centers will then enroll 3 additional patients. If 8 weeks later these 3 patients have had no severe adverse reactions, the same 3 study centers will enroll 3 more patients. At the end of this period, having ascertained the safety of the vaccine in the first 7 patients, the study will be opened to the remaining centers. Patients receive 2 doses of Varivax 6 to 8 weeks apart. Each week for 6 to 8 weeks after the first vaccine dose, the patient undergoes venipuncture and clinical assessment to characterize renal graft and liver function and identify any signs of varicella infection. Additional telephone follow-up occurs on Day 4 and twice weekly thereafter. Parents or guardians monitor the patient for evidence of rash or fever and immediately report any rashes or fevers to study physicians. If, after 6 to 8 weeks, the patient demonstrates no severe reactions to the vaccine and requires no antiviral therapy, the patient receives the second vaccine dose. The patient again receives weekly on-site and telephone follow-up for 6 weeks. Other visits occur 9 weeks and 14 weeks after the second vaccine dose and 1 year after the first vaccine dose. At these visits the patient undergoes venipuncture and clinical assessment to identify potential rejection events or varicella infection and to characterize VZV antibody responses and cytokine changes in response to the vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Varivax® | Experimental | Biological: Varivax®0.5 mL of Varivax administered subcutaneously in the right upper arm (deltoid region). |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Had a kidney transplant 1 year ago or more;
- Is between 2 and 21 years of age (parent or guardian's signed informed consent required if under 18);
- Is taking stable, maintenance doses of immunosuppressive drugs for his/her kidney transplant; and
- Is generally in good health.
Key exclusion criteria (10 listed)
- Has had any rejection episodes in the last 6 months or has other problems with their kidneys;
- Was in the hospital for a major infection in the last 30 days;
- Has a history of VZV infection, including chicken pox or shingles;
- Has ever received a VZV vaccine, including Varivax®;
- Lives with a person whose immune system does not work well;
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 |
|---|---|---|
| Varivax®Also: live-attenuated varicella zoster virus vaccine, varicella zoster virus vaccine, Oka-Merck live virus vaccineEach participant will receive 2 doses of Varivax 6 to 8 weeks apart. | Biological | Varivax® |
Primary outcome
Immediate adverse reactions
Time frame: 30 minutes post vaccination
Varicella related adverse reactions
Time frame: 1 year
1. Fever and local (<1 inch from inoculation site) lesions 2. Fever and lesions outside the 1 inch inoculation site 3. Lesions outside the 1 inch inoculation site 4. Clinical signs of pneumonitis 5. Clinical or chemical signs of hepatitis 6. Development of thrombocytopenia
Rejection events
Time frame: 1 year
1. Increase in creatinine 2. Renal biopsy
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- National Institute of Allergy and Infectious Diseases (NIAID) websiteLink provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT) websiteLink provided by the sponsor.
- NIAID Vaccine and Treatment Evaluation Units (VTEUs)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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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.
Amir Tejani, MD study chair
North American Pediatric Renal Transplantation Study (NAPRTCS)
Beverly L. Connelly, MD study chair
Vaccine and Treatment Evaluation Unit (VTEU)-Cincinnati Children's
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Varivax® in people with Kidney Transplant Recipients, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Slow enrollment). Results are not available in the source record.
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?
Immediate adverse reactions (time frame: 30 minutes post vaccination). 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 16 Feb 2017.