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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 below
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I have had an organ transplant and am on medication to prevent rejection.
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I have received at least 3 doses of the pneumonia vaccine.
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My child is between 1 and 4 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at different time points until 240 weeks post pcv 13 booster dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at different time points until 240 weeks post pcv 13 booster dose for reporting.

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

PCV13 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT01527591 — N/A
Solid Organ Transplant Infection Research Study Groups: vaccine
Solid Organ Transplant Infection Clinical Trial 2023: PCV13 Highlights & Side Effects. Trial Name: NCT01527591 — N/A
PCV13 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01527591 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Apr 2025