What side effects are associated with this type of intervention?

Common treatments for pneumococcal diseases include pneumococcal vaccines such as PCV13, PCV15, and PPSV23. The known side effects of these vaccines are generally mild and transient, including injection site reactions (pain, erythema, swelling), fever, and myalgias. Serious adverse events are rare but can include febrile seizures, urticaria, angioneurotic edema, anaphylaxis, and encephalopathy. The new pneumococcal vaccine with PF-07872411 being studied aims to enhance immune response, and its safety and efficacy are being evaluated in clinical trials.

What prior FDA approvals exist?

The FDA has previously approved several pneumococcal vaccines aimed at preventing diseases caused by Streptococcus pneumoniae. Notable among these are the 13-valent pneumococcal conjugate vaccine (PCV13), which protects against 13 types of pneumococcal bacteria, and the 23-valent pneumococcal polysaccharide vaccine (PPSV23), which covers 23 types. These vaccines have been shown to be effective in preventing invasive pneumococcal diseases such as meningitis, sepsis, and pneumonia. The new vaccine being studied, which includes the ingredient PF-07872411 to enhance immune response, aims to build on this foundation by potentially offering improved protection.

What other types of research exist?

Promising novel alternatives to the pneumococcal vaccine with PF-07872411 include the 15-valent pneumococcal conjugate vaccine (PCV15) and the 20-valent pneumococcal conjugate vaccine (PCV20). Both vaccines have been developed to provide broader serotype coverage and have shown promising immunogenicity and safety profiles in clinical trials. PCV15 and PCV20 are approved for use in adults and are being evaluated for their effectiveness in preventing pneumococcal diseases.

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Vaccine

New Pneumococcal Vaccine Ingredient for Pneumococcal Infections

Phase 1

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Participants may experience side effects from the vaccine which will be monitored through clinic visits and blood samples. Specific side effects are not listed but generally can include soreness at injection site, fever, fatigue, headache, muscle pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination

Percentage of participants reporting Medically Attended Adverse Events (MAAEs) within 12 months after vaccination

Percentage of participants reporting Medically Attended Adverse Events (MAAEs) within 6 months after vaccination

+7 more

Secondary study objectives

Pneumococcal opsonophagocytic activity (OPA) titers

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Low dose multivalent pneumococcal conjugate vaccine formulation BExperimental Treatment1 Intervention

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

Group II: Low dose multivalent pneumococcal conjugate vaccine formulation AExperimental Treatment1 Intervention

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

Group III: Standard dose multivalent pneumococcal conjugate vaccine controlActive Control1 Intervention

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

Group IV: Low dose of multivalent pneumococcal conjugate vaccine controlActive Control1 Intervention

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pneumococcal vaccines work by stimulating the immune system to produce antibodies against Streptococcus pneumoniae, the bacteria responsible for pneumococcal diseases such as meningitis, sepsis, and pneumonia. These vaccines typically contain inactivated or attenuated forms of the bacteria or its components, which help the body recognize and fight the pathogen in future encounters. The new ingredient in the vaccine being studied, PF-07872411, aims to enhance this immune response, potentially offering better protection. This is crucial for patients as a stronger immune response can lead to more effective prevention of severe and potentially life-threatening infections.

Pneumococcal vaccines for children and adults with bronchiectasis.