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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of the PCV13 vaccine in children who have undergone a solid organ transplant, such as a kidney or liver, and are on medications that weaken the immune system. Researchers aim to determine if the vaccine helps these children develop long-term immunity against pneumococcal infections, which can lead to serious illnesses like pneumonia. The trial is suitable for children aged 12 to 59 months who have been on immunosuppressive medications for at least three months and have already received some doses of a similar vaccine. As an unphased trial, this study provides a unique opportunity for children to potentially gain protection against serious infections while contributing to important research.

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 prior data suggests that the PCV13 vaccine is safe for solid organ transplant recipients?

Research has shown that the 13-valent pneumococcal conjugate vaccine (PCV13) is safe for patients. Previous studies found no new safety issues. Importantly, no cases of organ transplant rejections or antibody-related problems affecting transplants were reported. This indicates that PCV13 does not add extra risks for transplant patients.

Additionally, the vaccine is already recommended for adults over 50, demonstrating its general safety for a larger population. This existing use supports its safety, even though the current study focuses on its effects in children who have had organ transplants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PCV13 vaccine for solid organ transplant recipients because it offers targeted protection against pneumococcal infections, which are a significant risk for these patients. Unlike standard vaccinations that may not be as effective in immunocompromised individuals, PCV13 is a pneumococcal conjugate vaccine designed to enhance the immune response specifically in transplant recipients. Its ability to provide broader coverage against pneumococcal strains and its tailored approach to boosting immunity make it a promising option for those who need extra protection.

What evidence suggests that the PCV13 vaccine is effective for solid organ transplant recipients?

Research has shown that the PCV13 vaccine, which participants in this trial will receive, may protect organ transplant recipients from certain bacterial infections. One study found that 81% of transplant recipients were protected against these bacteria before their transplant after receiving a dose of PCV13. The vaccine also reduced hospital visits due to pneumonia by 3.8% overall. Although this reduction might seem small, it indicates that PCV13 can help prevent some serious infections in this vulnerable group. Overall, these findings support the vaccine's potential to strengthen the immune system in children who have received organ transplants. ^{3 6 7 8 9}

Who Is on the Research Team?

Jaime G Deville, MD, FAAP

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X21005946

Pneumococcal immunity and PCV13 vaccine response in ... Following one systematic dose of PCV13 at listing, 35/43 (81%) SOT-recipients were seroprotected at day of transplant against PCV13-serotypes ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30217523/

Pneumococcal vaccination in adult solid organ transplant ... A mathematical model estimated the effectiveness of polysaccharide vaccination in SOT recipients to be one third less than those of patients ...

3. academic.oup.com academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiaf405/8221349?searchresult=1

Effectiveness of 13-Valent Pneumococcal Conjugate Vaccine ... Vaccine effectiveness of PCV13 only against all-cause pneumonia hospitalization was 3.8% (95% CI 2.4%–5.2%) overall: 5.6% (3.9%–7.2%) for LTC ...

4. withpower.com withpower.com/trial/phase-1-2012-08c10

PCV13 Vaccine for 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 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0264410X1831209X

Pneumococcal vaccination in adult solid organ transplant ... Pneumococcal polysaccharide vaccination rates have been reported to be 60% in liver transplant recipients [5], and 62% in potential lung ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7746253/

Immunogenicity and safety of the 13-valent pneumococcal ... PCV13 was well tolerated; no new safety concerns emerged during the study. No anti-HLA antibodies or transplant rejections were reported. Sun et al.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6457056/

Efficacy and Safety of the Pneumococcal Conjugate-13 ... This review focuses on the immunogenicity, safety, efficacy and effectiveness data on the use of the 13-valent conjugate pneumococcal vaccine (PCV13) in adults.

8. cdc.gov cdc.gov/mmwr/volumes/74/wr/mm7401a1.htm

Expanded Recommendations for Use of Pneumococcal ... This report describes CDC's updated pneumococcal conjugate vaccine recommendation for all adults aged ≥50 years who are PCV-naïve or who ...

9. journals.lww.com journals.lww.com/transplantjournal/fulltext/2014/07151/immunogenicity_and_safety_of_13_valent.2634.aspx

Immunogenicity and Safety of 13-Valent Pneumococcal... Of 19 study patients receiving PCV13 before transplantation, 13 (68.4%) were liver transplant candidates, 5 (26.3%) were heart transplant candidates, and 1 (5.3 ...