Vaccine Education for Pneumonia

(PVI Trial)

Overseen By Patrick Hill, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Geisinger Clinic

Disqualifiers: Pneumonia, Active infections, Immunosuppressed, others

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

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial focuses on education about a vaccine, it's unlikely that you'll need to stop your medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on education about the pneumonia vaccine, so it's unlikely that your current medications will be affected.

What data supports the idea that Vaccine Education for Pneumonia is an effective drug?

The available research shows that the 20-valent pneumococcal conjugate vaccine (PCV20) is effective in preventing pneumococcal infections. It has been approved for use in both adults and children, indicating its safety and effectiveness. PCV20 covers more types of the bacteria that cause pneumonia compared to the earlier 13-valent vaccine, which means it can protect against more strains. Additionally, studies have shown that PCV20 is safe and works well in older adults, even those who have had previous pneumococcal vaccinations. This suggests that PCV20 is a strong option for preventing pneumonia and related diseases. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Pneumococcal Vaccine, Prevnar 20, Pneumococcal 20-valent Conjugate Vaccine, PCV20?

PCV20 has been shown to protect against 20 types of pneumococcal bacteria, expanding on the protection offered by the earlier PCV13 vaccine. It has been approved for preventing pneumonia and other serious infections in both adults and children, indicating its effectiveness in reducing pneumococcal diseases. ^{1 2 3 4 5}

What safety data exists for the 20-valent pneumococcal conjugate vaccine (PCV20)?

PCV20, also known as Prevnar 20, has undergone safety evaluations in both adult and pediatric populations. It was approved for adults in the USA in June 2021 and in the EU in February 2022 after demonstrating safety, immunogenicity, and effectiveness. In April 2023, it received pediatric approval in the USA for preventing invasive pneumococcal disease and otitis media. A pivotal Phase 3 trial evaluated its safety, tolerability, and immunogenicity in adults aged 18 and older, confirming its safety profile. ^{1 4 6 7 8}

Is the 20-valent pneumococcal conjugate vaccine (PCV20) safe for humans?

PCV20 has been evaluated for safety in both adults and children, and it has been approved for use in preventing pneumococcal infections. Clinical trials have shown it to be generally safe, with some adverse events reported, similar to other vaccines. ^{1 4 6 7 8}

Is the drug Pneumococcal Vaccine (Prevnar 20) a promising treatment for pneumonia?

Yes, the Pneumococcal Vaccine (Prevnar 20) is a promising treatment for pneumonia. It has been shown to effectively prevent infections caused by a wide range of bacteria types responsible for pneumonia. It has been approved for use in both adults and children, demonstrating strong immune responses and safety in clinical trials. ^{1 3 5 7 9}

How is the pneumococcal vaccine PCV20 different from other treatments for pneumonia?

PCV20 is unique because it covers 20 different strains of the bacteria that cause pneumonia, offering broader protection than previous vaccines like PCV13, which covered only 13 strains. This expanded coverage helps prevent more types of pneumococcal infections, making it a valuable tool in reducing the impact of these diseases. ^{1 3 5 7 9}

What is the purpose of this trial?

The goal of this interventional clinical trial is to investigate the impact of medicine and pharmacy-led education on patient acceptance rates of Prevnar 20 pneumonia vaccination in patients eligible to receive the vaccine. The education intervention and subsequent option to get the vaccine will be done while the patient is admitted to inpatient care, prior to discharge. The main questions the study aims to answer are: * Will supplemental education about the Prevnar 20 Pneumococcal vaccine influence patient acceptance rates when given a decision to receive it? * Is there any other statistically relevant qualitative reasoning behind the patient's final decision for accepting or refusing the vaccine?

Research Team

Jason Woloski, MD

Principal Investigator

Geisinger Clinic

Eligibility Criteria

This trial is for patients over 65 or those with diabetes, COPD, or asthma who haven't had a pneumonia vaccine and are currently in the hospital under Family Medicine care. It's to see if extra education about the Prevnar 20 vaccine increases how many decide to get vaccinated before leaving the hospital.

Inclusion Criteria

I am over 65 or have diabetes, COPD, or asthma.

Patients who have not been previously vaccinated against pneumonia

I am hospitalized and have Type I or II Diabetes.

Exclusion Criteria

I have received a pneumonia vaccine.

Patients who are in an immunosuppressed status

I am currently hospitalized with a diagnosis of pneumonia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

During hospital stay

Inpatient screening

Intervention

Pharmacy-led education intervention on Prevnar 20 vaccine during inpatient admission

During hospital stay

Inpatient education session

Decision and Data Collection

Patients decide on vaccine acceptance and complete a questionnaire on their decision reasoning

Prior to discharge

Inpatient decision and questionnaire

Study Completion

Data collection and analysis of vaccine acceptance rates and decision reasoning

Up to one year

Treatment Details

Interventions

• Pneumococcal Vaccine

Trial Overview The study tests whether providing additional information on the Prevnar 20 Pneumococcal vaccine by medical staff influences patients' willingness to receive it during their hospital stay. The focus is on understanding patient acceptance rates and reasons behind their decision.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Patients randomized into this arm RECEIVE Pneumococcal vaccine education prior to given the option to accept or refuse the vaccine.

Group II: Control Active Control 1 Intervention

Patients randomized into this arm DO NOT RECEIVE Pneumococcal vaccine education prior to given the option to accept or refuse the vaccine.

Pneumococcal Vaccine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Prevnar 20 for:

• Prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older.
• Prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks through 5 years of age.
• Prevention of pneumonia caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older.

Approved in European Union as Prevnar 20 for:

• Prevention of invasive pneumococcal disease and pneumonia caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older.

Approved in Canada as Prevnar 20 for:

• Prevention of invasive pneumococcal disease and pneumonia caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older.

Who Is Running the Clinical Trial?

Geisinger Clinic

Lead Sponsor

Trials

159

Recruited

1,976,000+

Findings from Research

The 20-valent pneumococcal conjugate vaccine (PCV20) has been approved for use in adults since June 2021 and in pediatric populations since April 2023, targeting a broader range of Streptococcus pneumoniae serotypes compared to the previous 13-valent vaccine.

PCV20 is effective in preventing invasive pneumococcal disease and otitis media in children aged 6 weeks to 17 years, demonstrating its safety and immunogenicity in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

20‑Valent Pneumococcal Conjugate Vaccine: Pediatric First Approval. Shirley, M.[2023]

The 20-valent pneumococcal conjugate vaccine (PCV20) significantly reduces the incidence and mortality of pneumococcal diseases in Danish adults compared to the 23-valent pneumococcal polysaccharide vaccine (PPV23), leading to substantial health benefits.

Vaccination with PCV20 is a cost-effective strategy, potentially saving up to 396 million EUR while gaining thousands of quality-adjusted life years (QALYs), making it a dominant choice for adults at moderate or high risk and those aged 65 and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of 20-valent pneumococcal conjugate vaccine in Denmark compared with PPV23. Olsen, J., Schnack, H., Skovdal, M., et al.[2022]

The 20-valent pneumococcal conjugate vaccine (PCV20) was found to be safe and well-tolerated in adults aged 65 and older, with similar rates of local reactions and adverse events compared to the control groups (PCV13 and PPSV23).

PCV20 elicited strong immune responses against all 20 serotypes included in the vaccine, demonstrating its effectiveness in boosting immunity regardless of prior pneumococcal vaccination history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults ≥65 years of age with different prior pneumococcal vaccination. Cannon, K., Elder, C., Young, M., et al.[2022]

The introduction of the heptavalent pneumococcal conjugate vaccine (PCV-7) led to a 27% decrease in invasive pneumococcal disease (IPD) among children in the Intermountain West from 1996 to 2003, indicating its effectiveness in reducing disease incidence.

While the vaccine reduced cases caused by PCV7 serogroups and antibiotic-resistant strains, there was a notable increase in IPD cases from non-PCV7 serogroups, along with a rise in severe cases and empyema, suggesting a shift in the epidemiology of pneumococcal disease post-vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal trends of invasive disease due to Streptococcus pneumoniae among children in the intermountain west: emergence of nonvaccine serogroups. Byington, CL., Samore, MH., Stoddard, GJ., et al.[2015]

The newly licensed 7-valent pneumococcal conjugate vaccine, Prevnar, has shown a significant impact on preventing pneumococcal pneumonia in children, marking an important advancement in pediatric health.

There is potential for similar saccharide-conjugate vaccines to be effective in preventing pneumococcal pneumonia in adults and the elderly, although there are barriers to their introduction in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-marketing effectiveness of Prevnar [pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein)] and implications for adult immunization. Parijs, BA., Malinoski, FJ.[2015]

The 20-valent pneumococcal conjugate vaccine (PCV20) was found to be safe and well tolerated, with no significant safety concerns reported in a phase 3 study involving adults across three age groups (18-49, 50-59, and ≥60 years).

PCV20 demonstrated comparable immunogenicity to the 13-valent PCV (PCV13) and the 23-valent polysaccharide vaccine (PPSV23), effectively inducing immune responses to all 20 vaccine serotypes, which suggests it could provide broader protection against pneumococcal disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pivotal Phase 3 Randomized Clinical Trial of the Safety, Tolerability, and Immunogenicity of 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥18 Years. Essink, B., Sabharwal, C., Cannon, K., et al.[2022]

The 13-valent pneumococcal conjugate vaccine (PCV13) is effective in preventing invasive pneumococcal disease in children and was approved for use in adults aged 50 and older to prevent pneumonia and related diseases.

Safety data and immunogenicity studies for PCV13 in adults were summarized to support recommendations for its use, highlighting its importance in protecting older populations from serious infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Licensure of 13-valent pneumococcal conjugate vaccine for adults aged 50 years and older. [2012]

A study analyzing data from Finnish population registers found no significant increase in adverse events after the introduction of the ten-valent Pneumococcal Conjugate Vaccine (PCV10) in children, except for a higher incidence of urticarial rash, which was attributed to changes in healthcare coding rather than the vaccine itself.

The findings suggest that public health concerns regarding adverse events linked to PCV10 are unfounded, highlighting the effectiveness of using real-world data for validating safety signals in vaccination programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Register-Based Ecologic Evaluation of Safety Signals Related to Pneumococcal Conjugate Vaccine in Children. Artama, M., Rinta-Kokko, H., Nohynek, H., et al.[2018]

The newly licensed 20-valent pneumococcal conjugate vaccine (PCV20) effectively induces strong immune responses against all 20 serotypes of Streptococcus pneumoniae, expanding coverage beyond the 13 serotypes included in PCV13.

PCV20 has a safety and tolerability profile similar to PCV13, making it a promising option for further reducing the incidence of pneumococcal disease in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

20-Valent Pneumococcal Conjugate Vaccine: A Review of Its Use in Adults. Shirley, M.[2022]

References

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

20‑Valent Pneumococcal Conjugate Vaccine: Pediatric First Approval. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of 20-valent pneumococcal conjugate vaccine in Denmark compared with PPV23. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults ≥65 years of age with different prior pneumococcal vaccination. [2022]

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

Temporal trends of invasive disease due to Streptococcus pneumoniae among children in the intermountain west: emergence of nonvaccine serogroups. [2015]

5. Ireland pubmed.ncbi.nlm.nih.gov

Post-marketing effectiveness of Prevnar [pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein)] and implications for adult immunization. [2015]

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

Pivotal Phase 3 Randomized Clinical Trial of the Safety, Tolerability, and Immunogenicity of 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥18 Years. [2022]

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

Licensure of 13-valent pneumococcal conjugate vaccine for adults aged 50 years and older. [2012]

8. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Register-Based Ecologic Evaluation of Safety Signals Related to Pneumococcal Conjugate Vaccine in Children. [2018]

9. New Zealand pubmed.ncbi.nlm.nih.gov

20-Valent Pneumococcal Conjugate Vaccine: A Review of Its Use in Adults. [2022]