Infection in Solid Organ Transplant RecipientsNCT01527591
Pneumococcal Conjugate Vaccine 13 (Prevnar13®) in Children Who Are Solid Organ Transplant Recipients (SOT)
A study testing Pneumococcal Conjugate Vaccine 13 (PCV13) in people with Infection in Solid Organ Transplant Recipients, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 59 months
- Conditions the study is for
- Infection in Solid Organ Transplant Recipients
- What is being tested?
- Pneumococcal Conjugate Vaccine 13 (PCV13)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2012to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety And Long-Term Immunogenicity Of The 13-Valent Pneumococcal Conjugate Vaccine In Children Who Are Solid Organ Transplant Recipients
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.
Read the 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.
- Being tested
- Pneumococcal Conjugate Vaccine 13 (PCV13)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal Conjugate Vaccine 13 (PCV13)Biological
Also called Prevnar13®
A single intramuscular dose of 0.5 mL.
| Study group | Role | What they receive |
|---|---|---|
| vaccine | Other | pneumococcal conjugated vaccine Receives: Biological: Pneumococcal Conjugate Vaccine 13 (PCV13) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure antibody concentrations by EIA and opsonophagocytosis assay (OPA)
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
Measured: Measured at different time points until 240 weeks post PCV 13 booster dose
Secondary outcomes (1)
To measure the extent and persistence of immunity by measuring antibody concentrations by EIA and OPA
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
Measured: Measured at different time points until 240 weeks post PCV 13 booster dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study start1 Feb 2012
- Primary completion31 Dec 2023
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection in Solid Organ Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime G. Deville, MD, FAAP, University of California, Los Angeles
- Investigators
- Jaime G Deville, MD, FAAP, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527591
- Sponsor's protocol ID
- Pfizer-Prevnar13®
- Status last verified
- Jan 2025
- First submitted
- 21 Dec 2011
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety And Long-Term Immunogenicity Of The 13-Valent Pneumococcal Conjugate Vaccine In Children Who Are Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT01527591
- Acronym / sponsor ID
- Pfizer-Prevnar13®
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 7 Feb 2012 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaccine | Other | Biological: Pneumococcal Conjugate Vaccine 13 (PCV13)pneumococcal conjugated vaccine |
Who may qualify
- Ages
- 12 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Pneumococcal Conjugate Vaccine 13 (PCV13)Also: Prevnar13®A single intramuscular dose of 0.5 mL. | Biological | vaccine |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
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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.
Jaime G Deville, MD, FAAP principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumococcal Conjugate Vaccine 13 (PCV13) in people with Infection in Solid Organ Transplant Recipients, run by University of California, Los Angeles 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
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). 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 2 Apr 2025.