New Pneumococcal Vaccine Ingredient for Pneumococcal Infections

Recruiting at 9 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: Severe COPD, End-stage renal, Cirrhosis, others

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

Compensation: Varies

Number of Visits: 8

Duration: 1 day

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new pneumococcal vaccine with an added ingredient to see if it works better. It involves healthy people aged 50-64 who haven't had similar vaccines before. The new ingredient is supposed to help the body fight off infections more effectively. Participants will get one shot and be monitored for several months.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have had certain vaccines recently, so it's best to discuss your medications with the study team.

What data supports the effectiveness of the treatment PF-07872411 for pneumococcal infections?

The research highlights the development of new pneumococcal vaccines that provide broad protection against various strains of the bacteria, which could imply potential effectiveness for treatments like PF-07872411. These vaccines have shown to induce strong immune responses and protect against multiple serotypes, suggesting that similar approaches could be effective for new treatments. ^{1 2 3 4 5}

What safety data exists for the new pneumococcal vaccine ingredient, possibly known as PF-07872411?

The safety of a new 24-valent pneumococcal vaccine was evaluated in a study with healthy adults aged 18 to 85, focusing on its safety and how well it was tolerated. Another study modified a pneumococcal vaccine strain to improve safety, showing that the changes made the vaccine safer without affecting its ability to protect against infections. ^{2 3 4 5 6}

How is the new pneumococcal vaccine treatment different from existing treatments?

The new pneumococcal vaccine treatment is unique because it uses a protein-based approach that targets multiple pneumococcal virulence factors, providing broad protection against various serotypes, including those not covered by current vaccines. It is administered intranasally, which helps induce strong mucosal immunity, offering a potentially more comprehensive defense against pneumococcal infections. ^{1 2 4 5 7}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for healthy adults aged 50 to 64 who haven't had a pneumococcal vaccine or any vaccines with extra ingredients in the last year. They should be able to use contraception if of childbearing potential and have stable health conditions.

Inclusion Criteria

I have a stable health condition for the last 6 months and am considered eligible for the study.

I am using or willing to use birth control during and after the study.

I am between 50 and 64 years old.

Exclusion Criteria

I do not have serious chronic disorders that would exclude me from the study.

History of a severe adverse reaction associated with a vaccine and/or severe allergic reaction to specific vaccines

I have not had a fever or any acute illness in the last 48 hours.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a single study vaccine shot in the upper arm muscle at the study clinic

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and laboratory tests

12 months

Up to 6 visits (in-person)

Treatment Details

Interventions

• PF-07872411

Trial Overview The study tests a new pneumococcal vaccine ingredient (PF-07872411) aimed at boosting its effectiveness against infections like meningitis and sepsis. Participants will receive different doses of this ingredient or a control vaccine, to assess safety and efficacy over about 12 months.

Participant Groups

Group I: Low dose multivalent pneumococcal conjugate vaccine formulation B Experimental Treatment 1 Intervention

Stage 2 - Participants will be randomized to receive a single injection.

Group II: Low dose multivalent pneumococcal conjugate vaccine formulation A Experimental Treatment 1 Intervention

Stage 1 - Participants will be randomized to receive a single injection.

Group III: Standard dose multivalent pneumococcal conjugate vaccine control Active Control 1 Intervention

Control - Stages 1 and 2 - Participants will be randomized to receive a single injection.

Group IV: Low dose of multivalent pneumococcal conjugate vaccine control Active Control 1 Intervention

Primary control - Stages 1 and 2 - Participants will be randomized to receive a single injection.

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

References

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

A broad-spectrum pneumococcal vaccine induces mucosal immunity and protects against lethal Streptococcus pneumoniae challenge. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Development of Next Generation Streptococcus pneumoniae Vaccines Conferring Broad Protection. [2020]

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

Comparing health outcomes and costs of general vaccination with pneumococcal conjugate vaccines in Sweden: a Markov model. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Phase 1/2 study of a novel 24-valent pneumococcal vaccine in healthy adults aged 18 to 64 years and in older adults aged 65 to 85 years. [2022]

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

Enhanced safety and immunogenicity of a pneumococcal surface antigen A mutant whole-cell inactivated pneumococcal vaccine. [2020]

6. Brazil pubmed.ncbi.nlm.nih.gov

Adverse events after pneumococcal vaccination. [2019]

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

Immunogenicity of PCV24, an expanded pneumococcal conjugate vaccine, in adult monkeys and protection in mice. [2021]