PCV13 Vaccine for Solid Organ Transplant Recipients

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must be taking: Immunosuppressive agents

Disqualifiers: Allergic reactions, Immune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

17 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must have been on immunosuppressive agents for at least 3 months, so you may need to continue those.

What data supports the effectiveness of the PCV13 treatment for solid organ transplant recipients?

Research shows that the PCV13 vaccine, when used in combination with another vaccine (PPSV23), helps produce specific antibodies in transplant recipients, which can protect against serious infections caused by Streptococcus pneumoniae. This suggests that PCV13 can be effective in reducing the risk of infections in solid organ transplant patients. ^{1 2 3 4 5}

Is the PCV13 vaccine safe for humans?

The PCV13 vaccine has been studied in both children and adults, showing no increased risk for serious side effects like seizures, allergic reactions, or asthma. However, there may be a possible link to Kawasaki disease, which needs more research. ^{2 6 7 8 9}

How is the PCV13 vaccine unique for solid organ transplant recipients?

The PCV13 vaccine is unique for solid organ transplant recipients because it is specifically designed to protect against 13 types of pneumococcal bacteria, which can cause serious infections. This is particularly important for transplant recipients who have weakened immune systems and are at higher risk for infections. ^{10 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Jaime G Deville, MD, FAAP

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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.

Inclusion 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.

My child is between 1 and 4 years old.

Exclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a booster dose of the 13-valent pneumococcal conjugate vaccine (PCV13)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, with antibody concentrations measured at different time points

240 weeks

Treatment Details

Interventions

• PCV13

Trial Overview 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.

Participant Groups

Group I: vaccine Experimental Treatment 1 Intervention

pneumococcal conjugated vaccine

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Findings from Research

In a study of 46 kidney transplant recipients, sequential vaccination with the 13-valent pneumococcal conjugate vaccine (PCV13) followed by the pneumococcal polysaccharide vaccine (PPSV23) resulted in significantly higher anti-pneumococcal antibody levels compared to baseline, indicating effective immune response.

No patients developed pneumococcal-associated pneumonia or experienced vaccination-related allograft rejection during the 12-month follow-up, suggesting that this vaccination strategy is both safe and effective for kidney transplant recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibody responses after sequential vaccination with PCV13 and PPSV23 in kidney transplant recipients. Mülling, N., van de Sand, L., Völk, K., et al.[2023]

A large safety monitoring study involving 599,229 doses of the 13-valent pneumococcal vaccine (PCV13) found no increased risk of serious adverse events like febrile seizures or anaphylaxis in children aged 1 month to 2 years.

While no significant increased risk of adverse events was identified compared to the previous 7-valent vaccine (PCV7), a potential association with Kawasaki disease warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in children. Tseng, HF., Sy, LS., Liu, IL., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Implementation of a vaccination clinic for adult solid organ transplant candidates: A single-center experience. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Early Impact of 13-Valent Pneumococcal Conjugate Vaccine Use on Invasive Pneumococcal Disease Among Adults With and Without Underlying Medical Conditions-United States. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Seven-valent pneumococcal conjugate vaccine in pediatric solid organ transplant recipients: a prospective study of safety and immunogenicity. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled trial to evaluate the prime-boost strategy for pneumococcal vaccination in adult liver transplant recipients. [2015]

5. Germany pubmed.ncbi.nlm.nih.gov

Antibody responses after sequential vaccination with PCV13 and PPSV23 in kidney transplant recipients. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among children aged 6-18 years with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Postlicensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in children. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 18-49 years of age, naive to 23-valent pneumococcal polysaccharide vaccine. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of the 13-valent pneumococcal conjugate vaccine in preventing invasive pneumococcal disease in children aged 7-59 months. A matched case-control study. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Impact of Medical Homes on Expenditures and Utilization for Beneficiaries With Behavioral Health Conditions. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Disparities in Self-reported Access to Patient-centered Medical Home Care for Children With Special Health Care Needs. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Impact of a medical home model on costs and utilization among comorbid HIV-positive Medicaid patients. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Pennsylvania's Medical Home Initiative: Reductions in Healthcare Utilization and Cost Among Medicaid Patients with Medicaland Psychiatric Comorbidities. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Characteristics Associated with Patient-Centered Medical Home Capability in Health Centers: A Cross-Sectional Analysis. [2018]