Pneumococcal Conjugate Vaccine 13 (Prevnar13®) in Children Who Are Solid Organ Transplant Recipients (SOT)
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|ClinicalTrials.gov Identifier: NCT01527591|
Recruitment Status : Recruiting
First Posted : February 7, 2012
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Infection in Solid Organ Transplant Recipients||Biological: Pneumococcal Conjugate Vaccine 13 (PCV13)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety And Long-Term Immunogenicity Of The 13-Valent Pneumococcal Conjugate Vaccine In Children Who Are Solid Organ Transplant Recipients|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||December 2018|
- Biological: Pneumococcal Conjugate Vaccine 13 (PCV13)
A single intramuscular dose of 0.5 mL.Other Name: Prevnar13®
- 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 ]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
- 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 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527591
|Contact: Jaime G Deville, MD, FAAP||(310)email@example.com|
|United States, California|
|Los Angeles, California, United States, 90095-1752|
|Contact: Kavita Shankar, MS, PhD 310-206-4173 firstname.lastname@example.org|
|Principal Investigator: Jaime G Deville, MD, FAAP|
|Principal Investigator:||Jaime G Deville, MD, FAAP||University of California, Los Angeles|