Pneumococcal Vaccine for Pneumococcal Infections

(Group 33/PCVs Trial)

Overseen By David LaFon, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Alabama at Birmingham

Must not be taking: Immunosuppressants

Disqualifiers: Pneumococcal vaccination, Chronic diseases, 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

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 aims to determine how well two different vaccines help the body produce antibodies to combat certain bacterial infections. Participants will receive either the PCV20 or PCV21 vaccine, and researchers will assess the effectiveness of each in generating bacteria-fighting antibodies. Healthy adults who have never received a pneumococcal vaccine and are not on immune-suppressing medications are suitable candidates for this trial. As a Phase 4 trial, the vaccines are already FDA-approved and proven effective, and this research seeks to understand how they benefit a broader range of patients.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on immunosuppressing medications (drugs that weaken the immune system).

What is the safety track record for these treatments?

Earlier studies found the PCV20 vaccine to be well-tolerated. Most side effects were minor, such as pain at the injection site, redness, or a mild fever, and these symptoms typically resolved on their own. PCV20 is approved for use in individuals as young as 6 weeks old, demonstrating its safety.

Research on PCV21 also indicates safety, with no major safety issues identified in the studies. The most common side effects were mild, such as soreness at the injection site. PCV21 is approved for adults and offers protection against more types of bacteria.

Both vaccines have undergone thorough testing and are considered safe for use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the pneumococcal vaccines PCV20 and PCV21 because they offer broader protection against pneumococcal infections compared to current vaccines like PCV13 and PPSV23. PCV20 and PCV21 include additional serotypes, which are variations of the bacteria that cause these infections, potentially reducing the number of cases even further. This expanded coverage could lead to better prevention strategies, helping to protect more people from serious illnesses like pneumonia, meningitis, and bloodstream infections.

What evidence suggests that this trial's vaccines could be effective for pneumococcal infections?

This trial will compare two pneumococcal vaccines: PCV20 and PCV21. Research has shown that the 20-valent pneumococcal conjugate vaccine (PCV20), which participants in this trial may receive, effectively boosts the immune system. It helps prevent about 12.5 cases of serious pneumococcal disease and 262.3 cases of pneumonia from any cause per 100,000 people each year. This vaccine is generally well-tolerated and protects against many types of bacteria. Meanwhile, PCV21, another vaccine option in this trial, shows promise by preventing more cases of serious pneumococcal disease and pneumonia without bacteria in the blood compared to PCV20. Both vaccines aim to protect adults from serious bacterial infections. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy adults who have never received a pneumococcal vaccine and are not on immunosuppressing medications or suffering from chronic diseases that affect the immune system.

Inclusion Criteria

I am a healthy adult.

Exclusion Criteria

I am not on immunosuppressants or have chronic diseases affecting my immune system.

No prior history of pneumococcal vaccination

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three different types of pneumococcal conjugate vaccines (PCV20, PCV15, or PCV21) to evaluate the effectiveness of antibodies produced by each vaccine in killing bacteria

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after vaccination, with serum antipneumococcal antibody concentrations and opsonic activity measured 4 weeks post-vaccination

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pneumococcal Vaccine

Trial Overview The study tests three different pneumococcal vaccines to see how well they induce antibodies capable of killing specific types of bacteria that cause pneumococcal diseases.

How Is the Trial Designed?

Group I: PCV21 Experimental Treatment 1 Intervention

Will receive PCV21

Group II: PCV20 Experimental Treatment 1 Intervention

Will receive PCV20

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

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

GRADE: 20-valent pneumococcal conjugate vaccine ... A systematic literature search was completed to review all available evidence on the immunogenicity and safety of PCV15 and PCV20 among age groups for which the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35171752/

The 20-valent pneumococcal conjugate vaccine (PCV20) PCV20 has proven to be well tolerated in vaccine-naïve adults and elicits a substantial immune response against all serotypes included.

3. infectiousdiseaseadvisor.com infectiousdiseaseadvisor.com/reports/ve-of-pcv20-against-ipd-wanes-with-increasing-patient-age/

Vaccine Efficacy of PCV20 Against IPD Wanes With ... Researchers estimated that PCV20 prevented 12.5 IPD cases and 262.3 all-cause pneumonia cases per 100,000 person-years. “This study presents the ...

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. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X24006169

Cost-effectiveness analysis of the 20-valent pneumococcal ... PCV20 more effectively prevents pneumococcal diseases and death than PCV13. Despite the higher vaccination costs, PCV20 reduced net disease ...

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

Pneumococcal Vaccine Safety Prevnar20 (PCV20) in 2023 for use in people 6 weeks and older. PCV20 helps protect against 20 types of pneumococcal bacteria that commonly ...

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

Post‑licensure Safety Surveillance of 20‑Valent ... Most reports (94%) were non-serious and comprised self-limiting local and systemic reactions such as injection-site pain, erythema, fever, and ...

8. prevnar20.com prevnar20.com/

PREVNAR 20® (Pneumococcal 20-Valent Conjugate Vaccine ... IMPORTANT SAFETY INFORMATION · Prevnar 20 should not be given to anyone who has had a severe allergic reaction to any component of Prevnar 20 or to diphtheria ...

9. academic.oup.com academic.oup.com/cid/article/73/7/e1489/5876773

Safety, Tolerability, and Immunogenicity of a 20-Valent ... PCV20 was well tolerated in adults 60 to 64 years of age, with a safety profile consistent with historical experience of PCVs in this age group.