Pneumococcal Vaccine for Splenic Injury

Overseen By Anthony Calabro, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Davis

Disqualifiers: Age, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

75 Participants Needed

Trial Summary

What is the purpose of this trial?

Persons without a spleen are susceptible to potentially lethal infections from certain bacteria, with pneumococcus being the most prevalent. Vaccines are provided to help protect against these infections, though they do not so with certainty. Trauma patients who sustain an injury to their spleen currently have three treatment options available for the treating surgeon - nonoperative management, embolization, or removal of the spleen. The purpose of this study is to investigate the antibody response to pneumococcal vaccine in patients undergoing these modes of therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Pneumovax-23 for patients with splenic injury?

Research shows that the 23-valent pneumococcal polysaccharide vaccine (PPSV23) is effective in protecting against invasive pneumococcal disease (IPD) in adults, with a pooled effectiveness of 45%. This suggests it may also help protect patients with splenic injury, who are at higher risk for infections. ^{1 2 3 4 5}

How does the drug Pneumovax-23 differ from other treatments for splenic injury?

Pneumovax-23 is unique because it is a vaccine specifically designed to protect against infections caused by Streptococcus pneumoniae, which is important for people with splenic injury who are at higher risk of infections. Unlike other treatments that might focus on managing the injury itself, this vaccine helps prevent potential complications by boosting the immune system's ability to fight off certain bacterial infections. ^{1 4 6 7 8}

Research Team

David V Shatz, MD

Principal Investigator

University of California, Davis

Eligibility Criteria

This trial is for adult trauma patients aged 18 to 65 who have sustained a splenic injury. It's not open to those under 18 or over 65, and if someone initially managed without surgery needs embolization or spleen removal later, they'll be taken out of the study.

Inclusion Criteria

I am between 18 and 65 years old and have a spleen injury from an accident.

Exclusion Criteria

I was initially not planned for surgery but had to undergo embolization or splenectomy and will be withdrawn from the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive the pneumococcal vaccine and baseline antibody levels are drawn

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for antibody response to the vaccine

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Pneumovax-23

Trial Overview The study is examining how well patients with splenic injuries respond to the Pneumovax-23 vaccine. This response will be compared across three different treatments: nonoperative management, embolization, and spleen removal.

Participant Groups

Group I: Nonoperative Active Control 1 Intervention

Pneumococcal vaccine (Pneumovax-23) will be administered within 72 hours of injury. Baseline antibody levels will be drawn at the time of vaccine administration, with response levels being drawn 4 weeks later.

Group II: Angioembolization Active Control 1 Intervention

Pneumococcal vaccine (Pneumovax-23) will be administered 14 days after embolization. Baseline antibody levels will be drawn at the time of vaccine administration, with response levels being drawn 4 weeks later.

Group III: Splenectomy Active Control 1 Intervention

Pneumococcal vaccine (Pneumovax-23) will be administered 14 days after splenectomy. Baseline antibody levels will be drawn at the time of vaccine administration, with response levels being drawn 4 weeks later.

Pneumovax-23 is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Pneumovax 23 for:

• Prevention of pneumococcal disease caused by the 23 serotypes of Streptococcus pneumoniae

Approved in European Union as Pneumovax 23 for:

• Prevention of pneumococcal disease caused by the 23 serotypes of Streptococcus pneumoniae

Approved in Canada as Pneumovax 23 for:

• Prevention of pneumococcal disease caused by the 23 serotypes of Streptococcus pneumoniae

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Findings from Research

The new pneumococcal conjugate vaccines, PCV15 and PCV20, have been shown to be safe and immunogenic in adults, providing a promising alternative to the previously recommended PCV13 and PPSV23 vaccines.

PCV13 demonstrated efficacy rates of 75% against PCV13-type invasive pneumococcal disease (IPD) and 45% against pneumococcal pneumonia (PP), while PPSV23 showed lower effectiveness of 45% against PPSV23-type IPD and only 18% against PPSV23-type PP, indicating that PCV13 offers better protection in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-Analysis of the Efficacy and Effectiveness of Pneumococcal Vaccines in Adults. Farrar, JL., Childs, L., Ouattara, M., et al.[2023]

Pneumococcal vaccines, including the 23-valent polysaccharide vaccine (PPSV23) and the 13-valent conjugate vaccine (PCV13), have significantly reduced infections caused by Streptococcus pneumoniae in both children and adults, highlighting their efficacy in preventing serious diseases like pneumonia and meningitis.

The development of new vaccine candidates is crucial due to observed serotype replacement with virulent strains not covered by existing vaccines, with eight potential protein antigens currently being researched for future pneumococcal vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Pneumococcal Vaccines: Current Polysaccharide Vaccine Recommendations and Future Protein Antigens. Daniels, CC., Rogers, PD., Shelton, CM.[2020]

A quality improvement initiative successfully increased the PPSV23 vaccination rates for high-risk pediatric patients from approximately 20% to 60% over a 12-month period across three specialty clinics.

The project involved implementing automated pre-visit planning reports and stocking vaccines, demonstrating that organized strategies can significantly enhance vaccination rates in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Pneumococcal Vaccination Rates in High-risk Children in Specialty Clinics. Harris, JG., Harris, LA., Olarte, L., et al.[2022]

In a study of 43 critically ill patients (16 burn and 27 neurosurgical), 87.5% of burn patients generated a successful immunologic response to the PPSV23 vaccine, compared to only 40.7% of neurosurgical patients, indicating that burn injury enhances vaccine responsiveness.

Burn patients not only had a higher rate of successful responses but also showed significantly greater median antibody levels and fold rises in IgG concentrations post-vaccination, suggesting that the type of injury influences the effectiveness of the vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Divergent humoral responses to 23-valent pneumococcal polysaccharide vaccine in critically-ill burn and neurosurgical patients. Mueller, SW., Baumgartner, LJ., MacLaren, R., et al.[2018]

In a study of 96 patients with chronic pulmonary diseases, the 23-valent polysaccharide pneumococcal vaccine (PPV-23) did not significantly reduce the overall risk of pneumococcal pneumonia, suggesting limited effectiveness in this high-risk group.

While there was a trend indicating potential benefits of vaccination against bacteremic pneumonia in older patients (75 years and older), the results were not statistically significant, highlighting the uncertainty surrounding the vaccine's efficacy in preventing pneumonia among patients with chronic pulmonary conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of 23-valent pneumococcal polysaccharide vaccine against pneumonia in patients with chronic pulmonary diseases: a matched case-control study. Vila-Corcoles, A., Ochoa-Gondar, O., Rodriguez-Blanco, T., et al.[2014]

In a study of 4128 elderly outpatients with chronic respiratory diseases, the 23-valent pneumococcal polysaccharide vaccine (PPSV23) was associated with a significantly lower risk of pneumococcal pneumonia, with an adjusted odds ratio of 0.39.

The vaccine showed even greater effectiveness in older age groups, with adjusted odds ratios of 0.16 for those aged 70 and 0.15 for those aged 75 and older, indicating strong protective benefits for the elderly population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a 23-valent pneumococcal polysaccharide vaccine for the prevention of pneumococcal pneumonia in the elderly with chronic respiratory diseases: a case-control study of a single center. Masuda, T., Nakatani, E., Shirai, T., et al.[2021]

In a study involving 10 adults (5 young and 5 old), the PCV13 vaccine successfully induced CD4 T-cell responses in all participants, with older individuals showing stronger and more polyfunctional responses compared to younger ones.

The presence of T follicular helper (Tfh) cells in younger participants correlated with improved antibody responses after receiving the PPSV23 booster, highlighting the role of Tfh cells in enhancing vaccine efficacy against pneumococcal infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral CD4 T follicular cells induced by a conjugated pneumococcal vaccine correlate with enhanced opsonophagocytic antibody responses in younger individuals. Sterrett, S., Peng, BJ., Burton, RL., et al.[2021]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-Analysis of the Efficacy and Effectiveness of Pneumococcal Vaccines in Adults. [2023]

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

A Review of Pneumococcal Vaccines: Current Polysaccharide Vaccine Recommendations and Future Protein Antigens. [2020]

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

Improving Pneumococcal Vaccination Rates in High-risk Children in Specialty Clinics. [2022]

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

Divergent humoral responses to 23-valent pneumococcal polysaccharide vaccine in critically-ill burn and neurosurgical patients. [2018]

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

Clinical effectiveness of 23-valent pneumococcal polysaccharide vaccine against pneumonia in patients with chronic pulmonary diseases: a matched case-control study. [2014]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a 23-valent pneumococcal polysaccharide vaccine for the prevention of pneumococcal pneumonia in the elderly with chronic respiratory diseases: a case-control study of a single center. [2021]

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

Peripheral CD4 T follicular cells induced by a conjugated pneumococcal vaccine correlate with enhanced opsonophagocytic antibody responses in younger individuals. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

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