Safety and Efficacy of ProQuad® in Children 6-24 Month Being Evaluated for Solid Organ Transplant (ProQuad®)

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)

Study Overview

• Status: Completed
• Conditions: RENAL INSUFFICIENCY, CHRONIC; LIVER FAILURE, ACUTE; HEART DISEASE
• Intervention / Treatment: Biological: ProQuad

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina, Pediatric Nephrology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Parent and/or legal guardian willing and able to give informed consent.

2. 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.

Exclusion Criteria:

1. History of allergy to any vaccine component, bleeding disorder, exposure to measles, mumps, rubella, varicella, or zoster in the 30 days prior to vaccination.
2. Receipt of any blood product or immunoglobulin received in the previous 180 days prior to vaccination.
3. Previously received any measles, mumps, rubella and/or varicella vaccine either alone or in combination prior to vaccination.
4. Any condition which causes the investigator to determine that the subject is not appropriate to enroll.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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: Open Label; 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..	Biological: ProQuad; 2) 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	"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.	"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.	"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.	"at least 30 days to less than 365 days post vaccination"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	"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.	"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.	"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.	"at least 30 days to less than 365 days post vaccination"

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Study Director: Katherine Twombley, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): November 3, 2016
• Study Completion (Actual): November 3, 2016

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 22, 2016

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: solid organ transplant; immunosuppressed; vaccines; ProQuad; MMRV
• Additional Relevant MeSH Terms: Digestive System Diseases; Hepatic Insufficiency; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Liver Diseases; Heart Diseases; Liver Failure; Renal Insufficiency, Chronic; Renal Insufficiency; Liver Failure, Acute
• Other Study ID Numbers: Pro25854

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No