New Pneumococcal Vaccine for Pneumonia

Recruiting at 4 trial locations

Age: 65+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: Invasive S pneumoniae disease

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

Compensation: Varies

Number of Visits: Unknown

Duration: Varies by group, up to 18 months

372 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new pneumococcal vaccine, which could help protect against pneumonia. Participants will randomly receive either the experimental PG4 vaccine, a standard vaccine, or a placebo (a substance with no active medicine). The trial will collect information on any side effects and monitor participants' health through clinic visits. It seeks healthy adults who have either never received a pneumococcal vaccine or had one more than five years ago. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that the PG4 vaccine is currently being tested for safety and tolerance. As this study is in its early stages, limited information exists on the vaccine's effects on people. However, early tests prioritize safety, so researchers will closely monitor and record any side effects.

The vaccine may cause minor side effects, such as soreness at the injection site or a mild fever, which are common with many vaccines. These effects typically do not last long. Participants will report any side effects during clinic visits, aiding researchers in understanding the vaccine's effects.

If this study finds the PG4 vaccine to be safe, further testing could confirm its effectiveness and safety in larger groups. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the PG4 vaccine for pneumonia because it introduces a novel approach by incorporating low and high dose adjuvants, PA-001 and PA-002, which could enhance the immune response. Unlike current pneumococcal vaccines like Prevnar 13 and Pneumovax 23, which do not use these specific adjuvants, the PG4 vaccine's tailored adjuvant strategies might improve its effectiveness and duration of protection. This could potentially lead to better prevention of pneumonia, especially in vulnerable populations, by boosting the body's defense mechanisms more efficiently.

What evidence suggests that this trial's treatments could be effective for pneumonia?

Research has shown that the PG4 vaccine, one of the treatments in this trial, may help the body combat pneumococcal bacteria, which can cause pneumonia, especially when combined with immune-boosting substances. Early studies with children indicated that the PG4 vaccine generated a strong immune response. Although data on adults is limited, the vaccine is designed to be safe and well-tolerated, aiming to enhance protection against pneumonia. This trial will explore various formulations of the PG4 vaccine, including different adjuvants and dose schedules, to identify the most effective approach. Using booster substances in vaccines has proven to increase their effectiveness, suggesting that the PG4 vaccine could help prevent pneumonia. ^{1 2 3 4 6}

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 adults who can participate in an 18-month study to test the safety and effectiveness of a new pneumococcal vaccine. Participants will receive either the experimental PG4 vaccine, a comparator PG4 vaccine, a standard 20-valent pneumococcal conjugate vaccine (20vPnC), or a saline injection placebo.

Inclusion Criteria

Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study

I have never had a pneumococcal vaccine or it's been over 5 years since I last had one.

Exclusion Criteria

I have had a serious infection caused by S pneumoniae.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to two doses of study vaccine or comparator

Varies by group, up to 18 months

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months after last vaccination

Follow-up visits for monitoring side effects and collecting blood samples

What Are the Treatments Tested in This Trial?

Interventions

• PG4 Vaccine

Trial Overview The study is testing various formulations of the PG4 pneumococcal vaccine with different buffers and adjuvant doses against a standard approved vaccine (20vPnC) and placebo. Participants will get up to two doses and attend follow-up visits for monitoring.

How Is the Trial Designed?

Group I: PG4 vaccine with low dose adjuvant PA-002; dose schedule 2 Experimental Treatment 1 Intervention

Group II: PG4 vaccine with low dose adjuvant PA-002; dose schedule 1 Experimental Treatment 1 Intervention

Group III: PG4 vaccine with low dose adjuvant PA-001; dose schedule 2 Experimental Treatment 1 Intervention

Group IV: PG4 vaccine with low dose adjuvant PA-001; dose schedule 1 Experimental Treatment 1 Intervention

Group V: PG4 vaccine with high dose adjuvant PA-002; dose schedule 2 Experimental Treatment 1 Intervention

Group VI: PG4 vaccine with high dose adjuvant PA-002; dose schedule 1 Experimental Treatment 1 Intervention

Group VII: PG4 vaccine with high dose adjuvant PA-001; dose schedule 2 Experimental Treatment 1 Intervention

Group VIII: PG4 vaccine with high dose adjuvant PA-001; dose schedule 1 Experimental Treatment 1 Intervention

Group IX: 20vPnC; dose schedule 2 Active Control 2 Interventions

Group X: PG4 vaccine; dose schedule 2 Active Control 2 Interventions

Group XI: 20vPnC; dose schedule 1 Active Control 2 Interventions

Group XII: PG4 vaccine; dose schedule 1 Active Control 2 Interventions

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. clinicaltrials.gov clinicaltrials.gov/study/NCT07086677

NCT07086677 | A Study to Learn About How a New ... The purpose of this study is to learn about the safety and tolerability of a pneumococcal vaccine in adults. Participants will receive either: an experimental ...

2. withpower.com withpower.com/trial/phase-1-streptococcus-pneumoniae-6-2025-c7f3c

New Pneumococcal Vaccine for Pneumonia This Phase 1 medical study run by Pfizer is evaluating whether PG4 Vaccine will have tolerable side effects & efficacy for patients with Pneumonia.

3. ctv.veeva.com ctv.veeva.com/study/a-study-to-learn-about-how-a-new-pneumococcal-vaccine-works-in-adults

A Study to Learn About How a New Pneumococcal Vaccine ... The purpose of this study is to learn about the safety and tolerability of a pneumococcal vaccine in adults.

4. pfizerclinicaltrials.com pfizerclinicaltrials.com/pneumococcal-vaccine-clinical-trials-children

Pneumococcal Vaccine Clinical Trials for Children This study is researching how well the study vaccine (called PG4) works in babies who have not started their routine pneumococcal vaccine series. All children ...

5. utmb.trialstoday.org utmb.trialstoday.org/list/print/NCT06524414

A Study to Learn About How a New Pneumococcal ... The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs in ...

6. studypages.com studypages.com/s/pfizer-pediatric-pneumococcal-conjugate-vaccine-study-749842/

Pfizer Pediatric Pneumococcal Conjugate Vaccine Study This study aims to check how safe and well-tolerated the PG4 vaccine is and how well it helps the immune system in healthy infants. The study will compare the ...