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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether education about the Prevnar 20 vaccine (Pneumococcal Vaccine) can influence people with diabetes to accept the vaccine for pneumonia prevention before leaving the hospital. Participants are divided into two groups: one receives information about the vaccine, and the other does not. This setup aims to determine if information changes their willingness to get vaccinated. The trial seeks participants who have diabetes, are over 65, or have conditions like COPD or asthma, and who have not yet been vaccinated against pneumonia. As an unphased trial, this study offers participants the chance to contribute to important research that could improve health education and vaccine acceptance.

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 prior data suggests that this educational intervention is safe?

Research has shown that Prevnar 20, a vaccine for pneumonia, is generally safe for adults. In one study, the Vaccine Adverse Event Reporting System (VAERS) received 1,976 reports after administration to individuals aged 19 and older. Only 6% of these reports involved serious issues.

Previous studies have found that most side effects are mild, such as soreness at the injection site or a mild fever. The vaccine protects against 20 types of bacteria that can cause pneumonia and other serious infections.

Overall, evidence suggests that Prevnar 20 is well-tolerated by recipients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how education can influence the decision to get vaccinated against pneumonia. Unlike the standard approach where patients might not receive detailed information before deciding on the pneumococcal vaccine, this trial tests the impact of providing education beforehand. Understanding whether education leads to higher vaccine acceptance rates could transform how we approach vaccinations, potentially increasing uptake and improving public health outcomes. This trial could reveal that informed patients are more likely to make proactive health choices, a finding that could be applied to other vaccines and health interventions.

What evidence suggests that this education intervention is effective for increasing acceptance of the pneumonia vaccine?

Research has shown that the Prevnar 20 vaccine effectively prevents pneumococcal pneumonia, a type of lung infection. Studies indicate that Prevnar 20 offers better protection against this illness compared to some older vaccines. It has proven effective in preventing invasive pneumococcal disease, which can be very serious. Although some studies have mixed results, the consensus is that Prevnar 20 reliably reduces the risk of pneumococcal infections, especially in older adults. This makes it a valuable option for those seeking protection from pneumonia. Participants in this trial will be randomized into two groups: one receiving education about the pneumococcal vaccine before deciding whether to accept or refuse it, and a control group that does not receive this education. ^{5 6 7 8 9}

Who Is on the Research Team?

Jason Woloski, MD

Principal Investigator

Geisinger Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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) 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10222197/

Systematic Review and Meta-Analysis of the Efficacy and ... Chandler et al. reported 2% (95% CI: −50%, 38%) vaccine effectiveness against PPSV23-type pneumococcal pneumonia in adults aged ≥65 years who ...

2. cdc.gov cdc.gov/acip/grade/pneumo-PCV20-age-based.html

GRADE: 20-valent pneumococcal conjugate vaccine ... Beneficial and harmful outcomes for the GRADE assessment were selected by the ACIP Pneumococcal Vaccines Work Group calls and via an email survey in which Work ...

3. cdc.gov cdc.gov/acip/evidence-to-recommendations/pneumo-PCV20-risk-based-etr.html

Evidence to Recommendations for PCV20 use among ... ... PCV20 has better vaccine effectiveness against disease (especially vaccine-type pneumococcal pneumonia) compared to PPSV23. No PCV20 studies ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06782282

A Study to Learn About How Well the Prevnar 20 Vaccine ... The purpose of this study is to learn about how well the Prevnar 20 vaccine (PCV20) stops invasive pneumococcal disease.

5. bmcinfectdis.biomedcentral.com bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-025-11596-w

a population-based cohort study, Catalonia, 2019 | BMC ... As main finding in this real-world data study, pneumococcal vaccination did not prove effective (neither PPsV23 nor PCV13) in preventing ...

6. prevnar20.com prevnar20.com/

PREVNAR 20® (Pneumococcal 20-Valent Conjugate Vaccine ... Helps protect eligible adults against 20 different strains of the bacteria that cause pneumococcal pneumonia and invasive pneumococcal disease (IPD). Prevnar 20 ...

7. cdc.gov cdc.gov/vaccine-safety/vaccines/pneumococcal.html

Pneumococcal Vaccine Safety A 2004 study of VAERS data found that most adverse events reported during the first two years after licensure of 7-valent pneumococcal conjugate ...

8. adult.prevnar20.com adult.prevnar20.com/safetyandsideeffects

Safety & Side Effects Learn about the safety risks, benefits and possible side effects of PREVNAR 20® (Pneumococcal 20-valent Conjugate Vaccine), a one-dose adult vaccine.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11973709/

Post‑licensure Safety Surveillance of 20‑Valent ... The VAERS received 1976 reports after PCV20 administration in persons aged ≥ 19 years (6% of reports involved serious events).