Trial record 5 of 55 for:    Open Studies | "Organ Transplantation"

Pneumococcal Conjugate Vaccine 13 (Prevnar13®) in Children Who Are Solid Organ Transplant Recipients (SOT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Jaime G. Deville, MD, FAAP, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01527591
First received: December 21, 2011
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to determine the safety and long-term immunogenicity of the 13-Valent Pneumococcal Conjugate vaccine in children who are solid organ transplant recipients.


Condition Intervention
Infection in Solid Organ Transplant Recipients
Biological: Pneumococcal Conjugate Vaccine 13 (PCV13)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety And Long-Term Immunogenicity Of The 13-Valent Pneumococcal Conjugate Vaccine In Children Who Are Solid Organ Transplant Recipients

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • To measure antibody concentrations by EIA and opsonophagocytosis assay (OPA) [ Time Frame: Measured at different time points until 240 weeks post PCV 13 booster dose ] [ Designated as safety issue: No ]
    Immunogenicity, functional antibody responses and sero-conversion will be evaluated by enzyme immunoassay (EIA) and opsonophagocytosis assay to a booster immunization with PCV13 vaccine in SOT-recipient children 12-59 months of age


Secondary Outcome Measures:
  • To measure the extent and persistence of immunity by measuring antibody concentrations by EIA and OPA [ Time Frame: Measured at different time points until 240 weeks post PCV 13 booster dose ] [ Designated as safety issue: No ]
    To measure the magnitude and persistence of humoral (EIA and OPA) anti--pneumococcal immune responses in children with SOT who were immunized with a booster dose of PCV 13 between 12 and 59 months of age


Estimated Enrollment: 45
Study Start Date: February 2012
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Pneumococcal Conjugate Vaccine 13 (PCV13)
    A single intramuscular dose of 0.5 mL.
    Other Name: Prevnar13®
Detailed Description:

The purpose of this study is to determine if a booster dose of 13-valent pneumococcal conjugate vaccine (PCV13) is safe and results in a measurable and durable immunologic response against pneumococcal subtypes present in the vaccine in solid organ transplant recipient (SOT) children.

Pneumococcal infections are amongst the most common infections seen in immunocompromised children. Infection by Streptococcus pneumoniae is one of the most frequently observed infection in immunocompromised children.

Pneumococcal polysaccharide vaccines (PPV) have been licensed in the U.S. for over 40 years. In contrast, pneumococcal conjugate vaccines are immunogenic and efficacious in normal infants and children, and offer hope of reducing pneumococcal infections in immunocompromised children. However, conjugate pneumococcal vaccine can only protect against a limited number of the 90 pneumococcal serotypes.

It is reasonable to anticipate that the introduction of PCV13 may help reduce the chances of severely immunocompromised children getting pneumococcal infections. Many of these children have been previously immunized with a full series of a 7-valent pneumococcal conjugate vaccine. These children will benefit from an additional dose of the new 13-valent vaccine. The degree to which SOT-recipient children are protected by prior immunizations and are responsive to new immunizations is still largely undefined. This study aims to expand the knowledge regarding the safety and immunogenicity of PCV13 immunization in this growing and vulnerable population.

  Eligibility

Ages Eligible for Study:   12 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are 12 to 59 months of age.
  • Have received a solid organ transplantation requiring ongoing immunosuppression.
  • Have been receiving immunosuppressive agents for at least 3 months. Non-steroidal anti-inflammatory agents, G-CSF, erythropoietin and inhaled corticosteroids are not considered immunosuppressive agents for the purposes of this study.
  • Expect to be able to complete the study injection and follow-up.
  • Have parent or guardian's consent.
  • Have received at least 3 doses of an approved PCV7 and/or PCV13 vaccine series.

Exclusion Criteria:

  • Have received any inactivated vaccine within 4 weeks, or any live vaccine within 6 weeks of entering the study.
  • Have had an allergic reaction or a serious side effect after receipt of any previous immunization to pneumococcal vaccines, or to other routine childhood immunizations.
  • Have any other condition that would make receiving study vaccine inadvisable.
  • Have other diseases of the immune system.
  • Have any other disease or previous surgery that would interfere with study treatment.
  • Are likely to have bleeding disorders.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527591

Contacts
Contact: Jaime G Deville, MD, FAAP (310)825-9660 jdeville@mednet.ucla.edu

Locations
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095-1752
Contact: Kavita Shankar, MS, PhD    310-206-4173    kshankar@mednet.ucla.edu   
Principal Investigator: Jaime G Deville, MD, FAAP         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Jaime G Deville, MD, FAAP University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Jaime G. Deville, MD, FAAP, Professor of Clinical Infectious Diseases, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01527591     History of Changes
Other Study ID Numbers: Pfizer-Prevnar13®
Study First Received: December 21, 2011
Last Updated: February 9, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 18, 2014