New Pneumococcal Vaccine Ingredient for Pneumococcal Infections

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ingredient in a vaccine designed to enhance protection against diseases caused by pneumococcal bacteria, such as meningitis, sepsis, ear infections, and sinusitis. Participants will receive one shot of the vaccine, either with or without the new ingredient, PF-07872411. Researchers will compare the results to determine the safety and effectiveness of the new ingredient. The study seeks healthy individuals aged 50 to 64 who have never received a pneumococcal vaccine. Participants will visit the clinic up to six times over 12 months to report any side effects and provide blood samples for testing. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine ingredient.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the new pneumococcal vaccine ingredient, PF-07872411, is being tested to enhance the vaccine's effectiveness against serious infections like meningitis and sepsis. In the early stages, the main goal is to assess how well people tolerate this new ingredient. As a Phase 1 trial, the treatment is being tested in humans for the first time. This phase typically involves a small group of healthy individuals to monitor side effects and observe the body's reaction to the treatment.

In similar studies with new vaccine ingredients, most participants experience mild side effects, such as soreness at the injection site, a slight fever, or fatigue. Serious side effects are rare at this stage. However, this trial will provide more detailed information on participants' reactions to PF-07872411, ensuring close monitoring of the ingredient's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer new formulations of multivalent pneumococcal conjugate vaccines, which could enhance protection against pneumococcal infections. Unlike standard vaccines, which typically use a fixed formulation, these experimental options explore low-dose versions that may still provide effective immunity while potentially reducing side effects. Additionally, the multivalent nature of these vaccines means they can target multiple strains of the bacteria at once, which is crucial for broader protection. This innovation could lead to more efficient vaccines and improve overall vaccination strategies against pneumococcal diseases.

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

Research shows that the new ingredient, PF-07872411, is designed to enhance the effectiveness of pneumococcal vaccines. These vaccines protect against serious infections caused by pneumococcal bacteria, such as meningitis (swelling of the brain and spine) and sepsis (a serious blood infection). Early studies suggest that this ingredient could strengthen the immune system, enabling the body to fight these infections more effectively. In this trial, participants will receive different formulations of a multivalent pneumococcal conjugate vaccine, including those with the new ingredient, to evaluate its effectiveness. Although specific data on its efficacy in people is still being gathered, its mechanism shows promise for improved protection against pneumococcal diseases. ^{1 4 5 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. withpower.com withpower.com/trial/phase-1-pneumococcal-infections-3-2023-55af2

New Pneumococcal Vaccine Ingredient for ... The study tests a new pneumococcal vaccine ingredient (PF-07872411) aimed at boosting its effectiveness against infections like meningitis and sepsis.

2. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05831124/

Trial | NCT05831124 The purpose of this clinical trial is to learn about a pneumococcal vaccine with a new ingredient (PF-07872411) intended to enhance the effects of the vaccine.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05831124/a-study-to-learn-about-a-type-of-pneumococcal-vaccine-with-a-new-ingredient-pf-07872411-intended-to-enhance-the-effects-of-the-vaccine-which-is-given-to-adults

A Study to Learn About a Type of Pneumococcal Vaccine ... The purpose of this clinical trial is to learn about a pneumococcal vaccine with a new ingredient (PF-07872411) intended to enhance the ...

4. synapse.patsnap.com synapse.patsnap.com/drug/0244381981dc4eab9729d3906474270d

PF-07872411 - Drug Targets, Indications, Patents PF-07872411: a Immunostimulants Drug, Initially developed by Pfizer Inc., Now, its global highest R&D status is Phase 1, Mechanism: Immunostimulants, ...

5. trial.medpath.com trial.medpath.com/clinical-trial/dc8a918ab1943e0e/nct06975319-v-212-safety-immunogenicity-healthy-adults

Phase I Study With V-212 Vaccinations in Healthy Adult ... Virometix AG, is conducting research into a vaccine (V-212) to prevent pneumococcal disease, which is any type of illness caused by infection with a ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-learn-about-a-type-of-pneumococcal-vaccine-with-a-new-ingredient-pf-07872411-intended-t

A Study to Learn About a Type of Pneumococcal Vaccine With ... The purpose of this clinical trial is to learn about a pneumococcal vaccine with a new ingredient (PF-07872411) intended to enhance the ...

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0031818

Pneumococcal Infection (DBCOND0031818) Associated Data ; NCT05696080. Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008). Corynebacterium diphtheriae ...