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

NCT ID: NCT02687763

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-11-03

Brief 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)

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.

Conditions

RENAL INSUFFICIENCY, CHRONIC; LIVER FAILURE, ACUTE; HEART DISEASE

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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..

Group Type: EXPERIMENTAL

ProQuad

Intervention Type: BIOLOGICAL

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:

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.

Interventions

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:

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Katherine Twombley

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine Twombley, MD

Role: STUDY_DIRECTOR

Medical University of South Carolina

Locations

Medical University of South Carolina, Pediatric Nephrology

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Pro25854

Identifier Type: -

Identifier Source: org_study_id