RENAL INSUFFICIENCY, CHRONICEarly Phase 1ProQuad®NCT02687763
Safety and Efficacy of ProQuad® in Children 6-24 Month Being Evaluated for Solid Organ Transplant
A Early Phase 1 study testing ProQuad in people with RENAL INSUFFICIENCY, CHRONIC and LIVER FAILURE, ACUTE, run by Medical University of South Carolina at 1 site in United States.
Trial summary
A prospective, multisite study to evaluate the Impact of Measles, Mumps, Rubella and Varicella ProQuad® vaccination in pediatric patients 6-24 months of age who are being considered and/or evaluated for any solid organ transplant (heart, liver or kidney) Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- RENAL INSUFFICIENCY, CHRONIC, LIVER FAILURE, ACUTE, HEART DISEASE
- What is being tested?
- ProQuad
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 3 Nov 2016
- Phase
- Early 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 6 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent and/or legal guardian willing and able to give informed consent.
- Patients 6 months to 24 months of age who are being considered and/or evaluated for any solid organ transplant within the next five (5) years who are willing:
- to receive two doses of ProQuad® at least 30 days but no more than 365 days apart.
- to participate in the three (3) antibody titer blood draws.
Who cannot join
- History of allergy to any vaccine component, bleeding disorder, exposure to measles, mumps, rubella, varicella, or zoster in the 30 days prior to vaccination.
- Receipt of any blood product or immunoglobulin received in the previous 180 days prior to vaccination.
- Previously received any measles, mumps, rubella and/or varicella vaccine either alone or in combination prior to vaccination.
- Any condition which causes the investigator to determine that the subject is not appropriate to enroll.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina, Pediatric Nephrology
Charleston, South Carolina, 29425
About this study
Official title: A Prospective, Multisite Study to Evaluate the Impact of Measles, Mumps, Rubella and Varicella ProQuad® Vaccination in Pediatric Patients 6-24 Months of Age Who Are Being Considered and/or Evaluated for Any Solid Organ Transplant
A prospective, multisite study to evaluate the Impact of Measles, Mumps, Rubella and Varicella ProQuad® vaccination in pediatric patients 6-24 months of age who are being considered and/or evaluated for any solid organ transplant (heart, liver or kidney)
Read the detailed description
Primary Aim:
To measure the antibody response to ProQuad® vaccination given earlier than the current recommended age in patients from the age of 6 months to 24 months who are being considered and/or evaluated for any solid organ transplant (heart, liver or kidney) within the next five years. These subjects would not reach the recommended ages to receive the vaccine before the transplant.
Hypothesis:
The Investigator proposes the hypothesis that the proposed study population will mount a clinically significant response to two (2) doses of the ProQuad® vaccine.
Primary Endpoint:
With respect to expected outcomes, the work proposed is expected to provide tools for optimizing the ProQuad® vaccination strategy in this population.
Secondary Aim:
To determine the safety of ProQuad® vaccination in children aged 6 months to 24 months who are being considered and/or evaluated for any solid organ transplant (heart, liver, kidney).
Hypothesis :
The Investigator proposes the hypothesis that the study population will have similar safety profiles compared to children who receive the vaccine at the recommended ages.
Secondary Endpoint:
The secondary outcome measure is represented by the children in the study having either no adverse effects or minimal adverse effects from the ProQuad® vaccine. Adverse effects will be monitored via Electronic Medical Records (EMR) for Emergency Department (ED), hospital or clinic visits, follow-up phone calls to the family/subjects, as well as the vaccination report card that the parents/legal guardians of the participants in the study will complete for their child for 7 days after he/she receives each dose of the vaccine.
- Being tested
- ProQuad
- Keywords
- vaccines, ProQuad, immunosuppressed, solid organ transplant, MMRV
- Medical subject headings
- Renal Insufficiency, Chronic, Liver Failure, Acute, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProQuadBiological
- Patients 6 months to 24 months of age who are being considered and/or evaluated for any solid organ transplant within the next five (5) years who are willing:
- to receive two doses of ProQuad® at least 30 days but no more than 365 days apart.
- to participate in the three (3) antibody titer blood draws.
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Open Label. Two 0.5-mL doses of ProQuad® will be given by intramuscular injection at least 30 days but no more than 365 days apart.. Receives: Biological: ProQuad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Varicella IgG Antibody Titer ≥ 1.1 IU/ml
Percentage of Participants with Varicella IgG Antibody Titer ≥ 1.1 IU/ml: at least 30 days to less than 365 days post vaccination.
Measured: "at least 30 days to less than 365 days post vaccination"
Measles IgG Antibody Titer ≥ 30AU/ml
Percentage of Participants with post vaccination Measles IgG Antibody Titer ≥ 30AU/ml: at least 30 days to less than 365 days post vaccination.
Measured: "at least 30 days to less than 365 days post vaccination"
Mumps IgG Antibody Titer ≥ 11AU/ml
Percentage of Participants tested for Mumps IgG Antibody Titer ≥ 11AU/ml: at least 30 days to less than 365 days post vaccination.
Measured: "at least 30 days to less than 365 days post vaccination"
Rubella IgG Antibody Titer ≥ 15 IU/mL
Percentage of Participants tested for Rubella IgG Antibody Titer ≥ 15 IU/mL: at least 30 days to less than 365 days post vaccination.
Measured: "at least 30 days to less than 365 days post vaccination"
Secondary outcomes (4)
Geometric Mean Titer (GMT) of Varicella Antibody
Geometric Mean Titer (GMT) of Varicella Antibody participating subjects at three different points in time. Antibody titers will be reported as geometric mean concentrations (GMCs) with 95% confidence intervals (CIs). Responses to historical controls will be compared by Student paired or unpaired t test and Fisher exact test. P < .05 will be considered statistically significant.
Measured: "at least 30 days to less than 365 days post vaccination"
Geometric Mean Titer (GMT) of Measles Antibody
Geometric Mean Titer (GMT) of Measles Antibody participating subjects at three different points in time. Antibody titers will be reported as geometric mean concentrations (GMCs) with 95% confidence intervals (CIs). Responses to historical controls will be compared by Student paired or unpaired t test and Fisher exact test. P < .05 will be considered statistically significant.
Measured: "at least 30 days to less than 365 days post vaccination"
Geometric Mean Titer (GMT) of Mumps Antibody
Geometric Mean Titer (GMT) of Mumps Antibody participating subjects at three different points in time. Antibody titers will be reported as geometric mean concentrations (GMCs) with 95% confidence intervals (CIs). Responses to historical controls will be compared by Student paired or unpaired t test and Fisher exact test. P < .05 will be considered statistically significant.
Measured: "at least 30 days to less than 365 days post vaccination"
Geometric Mean Titer (GMT) of Rubella Antibody
Geometric Mean Titer (GMT) of Rubella Antibody participating subjects at three different points in time. Antibody titers will be reported as geometric mean concentrations (GMCs) with 95% confidence intervals (CIs). Responses to historical controls will be compared by Student paired or unpaired t test and Fisher exact test. P < .05 will be considered statistically significant.
Measured: "at least 30 days to less than 365 days post vaccination"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startDec 2015
- Primary completion3 Nov 2016
- Study completion3 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RENAL INSUFFICIENCY, CHRONICStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Twombley, Medical University of South Carolina
- Investigators
- Katherine Twombley, MD, Study director, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687763
- Sponsor's protocol ID
- Pro25854
- Acronym
- ProQuad®
- Status last verified
- Feb 2019
- First submitted
- 28 Jan 2016
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multisite Study to Evaluate the Impact of Measles, Mumps, Rubella and Varicella ProQuad® Vaccination in Pediatric Patients 6-24 Months of Age Who Are Being Considered and/or Evaluated for Any Solid Organ Transplant
- ClinicalTrials.gov ID
- NCT02687763
- Acronym / sponsor ID
- ProQuad® / Pro25854
- Keywords
- vaccines, ProQuad, immunosuppressed, solid organ transplant, MMRV
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 3 Nov 2016 (actual)
- Study completion
- 3 Nov 2016 (actual)
- First posted
- 22 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.
A prospective, multisite study to evaluate the Impact of Measles, Mumps, Rubella and Varicella ProQuad® vaccination in pediatric patients 6-24 months of age who are being considered and/or evaluated for any solid organ transplant (heart, liver or kidney)
Detailed description
Primary Aim:
To measure the antibody response to ProQuad® vaccination given earlier than the current recommended age in patients from the age of 6 months to 24 months who are being considered and/or evaluated for any solid organ transplant (heart, liver or kidney) within the next five years. These subjects would not reach the recommended ages to receive the vaccine before the transplant.
Hypothesis:
The Investigator proposes the hypothesis that the proposed study population will mount a clinically significant response to two (2) doses of the ProQuad® vaccine.
Primary Endpoint:
With respect to expected outcomes, the work proposed is expected to provide tools for optimizing the ProQuad® vaccination strategy in this population.
Secondary Aim:
To determine the safety of ProQuad® vaccination in children aged 6 months to 24 months who are being considered and/or evaluated for any solid organ transplant (heart, liver, kidney).
Hypothesis :
The Investigator proposes the hypothesis that the study population will have similar safety profiles compared to children who receive the vaccine at the recommended ages.
Secondary Endpoint:
The secondary outcome measure is represented by the children in the study having either no adverse effects or minimal adverse effects from the ProQuad® vaccine. Adverse effects will be monitored via Electronic Medical Records (EMR) for Emergency Department (ED), hospital or clinic visits, follow-up phone calls to the family/subjects, as well as the vaccination report card that the parents/legal guardians of the participants in the study will complete for their child for 7 days after he/she receives each dose of the vaccine.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Biological: ProQuadOpen Label. Two 0.5-mL doses of ProQuad® will be given by intramuscular injection at least 30 days but no more than 365 days apart.. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Parent and/or legal guardian willing and able to give informed consent.
- Patients 6 months to 24 months of age who are being considered and/or evaluated for any solid organ transplant within the next five (5) years who are willing:
Key exclusion criteria (4 listed)
- History of allergy to any vaccine component, bleeding disorder, exposure to measles, mumps, rubella, varicella, or zoster in the 30 days prior to vaccination.
- Receipt of any blood product or immunoglobulin received in the previous 180 days prior to vaccination.
- Previously received any measles, mumps, rubella and/or varicella vaccine either alone or in combination prior to vaccination.
- Any condition which causes the investigator to determine that the subject is not appropriate to enroll.
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 |
|---|---|---|
| ProQuad2) Patients 6 months to 24 months of age who are being considered and/or evaluated for any solid organ transplant within the next five (5) years who are willing: 1. to receive two doses of ProQuad® at least 30 days but no more than 365 days apart. 2. to participate in the three (3) antibody titer blood draws. | Biological | Open Label |
Primary outcome
Varicella IgG Antibody Titer ≥ 1.1 IU/ml
Time frame: "at least 30 days to less than 365 days post vaccination"
Percentage of Participants with Varicella IgG Antibody Titer ≥ 1.1 IU/ml: at least 30 days to less than 365 days post vaccination.
Measles IgG Antibody Titer ≥ 30AU/ml
Time frame: "at least 30 days to less than 365 days post vaccination"
Percentage of Participants with post vaccination Measles IgG Antibody Titer ≥ 30AU/ml: at least 30 days to less than 365 days post vaccination.
Mumps IgG Antibody Titer ≥ 11AU/ml
Time frame: "at least 30 days to less than 365 days post vaccination"
Percentage of Participants tested for Mumps IgG Antibody Titer ≥ 11AU/ml: at least 30 days to less than 365 days post vaccination.
Rubella IgG Antibody Titer ≥ 15 IU/mL
Time frame: "at least 30 days to less than 365 days post vaccination"
Percentage of Participants tested for Rubella IgG Antibody Titer ≥ 15 IU/mL: at least 30 days to less than 365 days post vaccination.
4 secondary outcomes
Geometric Mean Titer (GMT) of Varicella Antibody
Time frame: "at least 30 days to less than 365 days post vaccination"
Geometric Mean Titer (GMT) of Measles Antibody
Time frame: "at least 30 days to less than 365 days post vaccination"
Geometric Mean Titer (GMT) of Mumps Antibody
Time frame: "at least 30 days to less than 365 days post vaccination"
Geometric Mean Titer (GMT) of Rubella Antibody
Time frame: "at least 30 days to less than 365 days post vaccination"
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 12 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Katherine Twombley, MD study director
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ProQuad in people with RENAL INSUFFICIENCY, CHRONIC and LIVER FAILURE, ACUTE, run by Medical University of South Carolina at 1 site 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 4 inclusion and 4 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 12 Feb 2019. 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Varicella IgG Antibody Titer ≥ 1.1 IU/ml (time frame: "at least 30 days to less than 365 days post vaccination"). 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 12 Feb 2019.