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Cancer Vaccine
PCV13 Vaccine for Solid Organ Transplant Recipients
N/A
Waitlist Available
Led By Jaime G Deville, MD, FAAP
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have received a solid organ transplantation requiring ongoing immunosuppression
Have received at least 3 doses of an approved PCV7 and/or PCV13 vaccine series
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at different time points until 240 weeks post pcv 13 booster dose
Awards & highlights
Study Summary
This trial will test a vaccine to see if it's safe & effective for children with organ transplants.
Who is the study for?
This trial is for children aged 12 to 59 months who have had a solid organ transplant and are on immunosuppressive drugs (excluding certain non-steroidal agents). They must have completed at least three doses of an approved pneumococcal vaccine series, can complete the study, and have parental consent. Children with immune diseases, bleeding disorders, recent vaccinations, or severe reactions to vaccines cannot participate.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness over time of the Pneumococcal Conjugate Vaccine 13 (PCV13) in young children who have received solid organ transplants. The goal is to see how well these children's bodies respond to the vaccine given their unique health situation.See study design
What are the potential side effects?
While not specified here, common side effects of PCV13 in transplant recipients may include pain at injection site, fever, fatigue, headache and muscle pain. Serious allergic reactions are rare but possible.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had an organ transplant and am on medication to prevent rejection.
Select...
I have received at least 3 doses of the pneumonia vaccine.
Select...
My child is between 1 and 4 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at different time points until 240 weeks post pcv 13 booster dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at different time points until 240 weeks post pcv 13 booster dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To measure antibody concentrations by EIA and opsonophagocytosis assay (OPA)
Secondary outcome measures
To measure the extent and persistence of immunity by measuring antibody concentrations by EIA and OPA
Trial Design
1Treatment groups
Experimental Treatment
Group I: vaccineExperimental Treatment1 Intervention
pneumococcal conjugated vaccine
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,528 Previous Clinical Trials
10,276,834 Total Patients Enrolled
Jaime G Deville, MD, FAAPPrincipal InvestigatorUniversity of California, Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on immunosuppressive drugs for over 3 months, not including NSAIDs, G-CSF, erythropoietin, or inhaled corticosteroids.I have received at least 3 doses of the pneumonia vaccine.I don't have any conditions or past surgeries that would affect the study treatment.I do not have any health conditions that would make getting a study vaccine unsafe.I have a condition that affects my immune system.My child is between 1 and 4 years old.I have had an organ transplant and am on medication to prevent rejection.I haven't had any inactivated vaccines in the last 4 weeks or live vaccines in the last 6 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: vaccine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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