Pneumococcal Vaccine for Pneumococcal Disease

Not currently recruiting at 20 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Pfizer

Disqualifiers: Severe vaccine reaction, Immunosuppression, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and immune response of new pneumococcal vaccine candidates, which could help protect against pneumococcal disease. Participants will receive one of several vaccine formulations, including the 20-valent pneumococcal conjugate vaccine (20vPnC), or an existing vaccine as a single injection in the upper arm. The study progresses through multiple stages and seeks adults with no history of receiving a pneumococcal vaccine or those who haven't had one recently. It suits adults who are generally healthy but may have stable, existing conditions. Participants must attend a few clinic visits and provide blood samples over several months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

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, you cannot receive any other pneumococcal vaccines during the study, and you should not have received any inactivated vaccines within 14 days or live vaccines within 28 days before the study vaccine.

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

Research shows that the 20-valent pneumococcal conjugate vaccine (20vPnC), also known as Prevnar 20, is generally safe for adults. Approved for those aged 18 and over, it has a safety profile similar to other vaccines. However, it should not be given to anyone who has had a severe allergic reaction to any part of the vaccine.

Studies have found that the Multivalent Pneumococcal Vaccine - Formulation 1 is well-tolerated, with side effects like sore arms and general reactions similar to those of other vaccines. Previous patients demonstrated a good immune response with no major safety concerns.

For Multivalent Pneumococcal Vaccine - Formulation 2, safety evaluations have not identified any major issues. It appears as safe as other pneumococcal vaccines, with typical side effects and a strong immune response.

Research on Multivalent Pneumococcal Vaccine - Formulation 3 suggests it is safe and produces a good immune response, with side effects similar to those of other vaccines.

Finally, Multivalent Pneumococcal Vaccine - Formulation 4 also appears safe based on research, with a safety profile featuring common side effects like other pneumococcal vaccines.

Overall, these vaccines have undergone safety testing, and current data suggest they are well-tolerated. Participants can expect typical vaccine side effects, such as soreness or mild fever, but serious issues are rare. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for pneumococcal disease because they offer new ways to improve protection against a wider range of pneumococcal bacteria. The 20-valent pneumococcal conjugate vaccine (20vPnC) includes 20 different types of bacterial strains, potentially offering broader coverage compared to existing vaccines like the 13-valent and 23-valent vaccines. Additionally, the multivalent formulations being tested aim to enhance immunity by targeting even more strains, which could significantly reduce the incidence of pneumococcal infections. This broader protection is crucial, as it can lead to better prevention of severe illnesses like pneumonia, meningitis, and sepsis caused by these bacteria.

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

Research has shown that the 20-valent pneumococcal conjugate vaccine (20vPnC), which participants in this trial may receive, helps prevent serious infections like invasive pneumococcal disease (IPD) and pneumonia, especially in older adults. Real-world studies found it reduced the risk of IPD by 25.6% across different risk groups. This trial will also test Multivalent Pneumococcal Vaccine - Formulations 1, 2, 3, and 4, which are similar vaccines being evaluated for their potential to offer protection against pneumococcal diseases, particularly when given as a single dose. These vaccines stimulate the immune system to protect against multiple types of the pneumococcus bacteria. Overall, they show promise in lowering the risk of diseases caused by these bacteria. ^{6 7 8 9 10}

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 to test a new pneumococcal vaccine. Stage 1 includes those aged 18-49, while Stage 2 includes individuals 50 and older. Participants must be willing to give blood samples and report any side effects during clinic visits over a period of up to one year.

Inclusion Criteria

I am an adult considered fit for the study and have had stable health conditions for the last 12 weeks.

I agree to use contraception for 28 days after the study, or I cannot have children.

I am 18-49 years old and have never received a pneumococcal vaccine.

Exclusion Criteria

I plan to receive a pneumococcal vaccine.

I haven't had nonlive vaccines in 14 days or live vaccines in 28 days.

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Treatment

Participants aged 18-49 receive a single injection of one of two pneumococcal vaccine candidates or 20vPnC (Prevnar 20)

6 months

2 to 4 clinic visits, 1 phone visit

Stage 2 Treatment

Participants aged 50 and older receive the chosen pneumococcal vaccine candidate from Stage 1 or 20vPnC (Prevnar 20)

12 months

2 to 4 clinic visits, 1 phone visit

Stage 3 Treatment

Participants aged 50 and older receive the chosen pneumococcal vaccine candidate from Stage 1 or a licensed pneumococcal comparator vaccine

6 months

2 to 4 clinic visits, 1 phone visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• 20-valent pneumococcal conjugate vaccine (20vPnC)
• Multivalent Pneumococcal Vaccine - Formulation 1
• Multivalent Pneumococcal Vaccine - Formulation 2

Trial Overview The study tests two different formulations of a new pneumococcal vaccine against an existing vaccine (20vPnC, Prevnar 20). Each participant receives one shot in the upper arm muscle and is monitored for immune response and safety.

How Is the Trial Designed?

Group I: Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 4 Experimental Treatment 1 Intervention

Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 4.

Group II: Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 3 Experimental Treatment 1 Intervention

Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 3.

Group III: Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 2 Experimental Treatment 1 Intervention

Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 2. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4).

Group IV: Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 1 Experimental Treatment 1 Intervention

Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 1. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4).

Group V: Phase 2 (Stage 3): a licensed pneumococcal comparator vaccine Active Control 1 Intervention

Participants to receive a single injection of a licensed pneumococcal comparator vaccine.

Group VI: Phase 1 (Stage 1) and Phase 2 (Stage 2): 20-valent pneumococcal conjugate vaccine (20vPnC) Active Control 1 Intervention

Participants to receive a single injection of 20vPnC.

20-valent pneumococcal conjugate vaccine (20vPnC) is already approved in United States, European Union for the following indications:

Approved in United States as Prevnar 20 for:

• Invasive pneumococcal disease in infants and children

Approved in European Union as Prevnar 20 for:

• Active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F

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

Published Research Related to This Trial

The 13-Valent pneumococcal conjugate vaccine (PCV13) is as effective as the 7-Valent vaccine (PCV7) in generating immune responses against the common serotypes of pneumococcal disease, while also providing additional protection against 6 extra serotypes.

Both vaccines have similar safety profiles, with PCV13 showing mild reactogenicity, indicating it is a safe option for infants receiving routine vaccinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Yeh, SH., Gurtman, A., Hurley, DC., et al.[2015]

The 20-valent pneumococcal conjugate vaccine (PCV20) showed consistent and robust immune responses across three different lots, indicating its effectiveness in generating immunity against all 20 serotypes tested.

The safety profile of PCV20 was comparable to that of the 13-valent vaccine (PCV13), with similar rates of mild to moderate local reactions and adverse events, suggesting it is a safe option for vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 3, randomized, double-blind study to evaluate the immunogenicity and safety of 3 lots of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults 18 through 49 years of age. Klein, NP., Peyrani, P., Yacisin, K., et al.[2022]

The 13-valent pneumococcal conjugate vaccine (13vPnC) was found to be immunogenic in healthy Japanese adults, showing adequate antibody responses for most serotypes, which supports its potential use in children and older adults.

While there was a trend towards more local reactions with the 13vPnC compared to the 23-valent polysaccharide vaccine (23vPn), these reactions were mostly mild or moderate, indicating that the vaccine is generally well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 trial of 13-valent pneumococcal conjugate vaccine in Japanese adults. Scott, D., Ruckle, J., Dar, M., et al.[2016]

The 20-valent pneumococcal conjugate vaccine (PCV20) has been approved for use in adults since June 2021 and in pediatric populations since April 2023, targeting a broader range of Streptococcus pneumoniae serotypes compared to the previous 13-valent vaccine.

PCV20 is effective in preventing invasive pneumococcal disease and otitis media in children aged 6 weeks to 17 years, demonstrating its safety and immunogenicity in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

20‑Valent Pneumococcal Conjugate Vaccine: Pediatric First Approval. Shirley, M.[2023]

The 20-valent pneumococcal conjugate vaccine (PCV20) significantly reduces the incidence and mortality of pneumococcal diseases in Danish adults compared to the 23-valent pneumococcal polysaccharide vaccine (PPV23), leading to substantial health benefits.

Vaccination with PCV20 is a cost-effective strategy, potentially saving up to 396 million EUR while gaining thousands of quality-adjusted life years (QALYs), making it a dominant choice for adults at moderate or high risk and those aged 65 and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of 20-valent pneumococcal conjugate vaccine in Denmark compared with PPV23. Olsen, J., Schnack, H., Skovdal, M., et al.[2022]

In a study of 115 children aged 2-3 years who had not been previously vaccinated, the pneumococcal seven-valent conjugate vaccine (Prevenar) was found to be safe, with common local reactions like redness (40%) and tenderness (39.1%), and systemic reactions such as fever in only 7% of cases.

The vaccine demonstrated high immunogenicity, with over 98% of participants achieving sufficient antibody levels for all seven serotypes, indicating it effectively stimulates the immune response in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the safety and immunogenicity of pneumococcal seven-valent conjugate vaccine (Prevenar) administered in previously unvaccinated Spanish children aged 24 to 36 months. de Arístegui Fernández, J., Cos Arregui, B., Zurimendi Carril, A., et al.[2022]

The 20-valent pneumococcal conjugate vaccine (PCV20) was found to be safe and well-tolerated in adults aged 65 and older, with similar rates of local reactions and adverse events compared to the control groups (PCV13 and PPSV23).

PCV20 elicited strong immune responses against all 20 serotypes included in the vaccine, demonstrating its effectiveness in boosting immunity regardless of prior pneumococcal vaccination history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults ≥65 years of age with different prior pneumococcal vaccination. Cannon, K., Elder, C., Young, M., et al.[2022]

Citations

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

GRADE: 20-valent pneumococcal conjugate vaccine ... Beneficial and harmful outcomes for the GRADE assessment were selected by the ACIP Pneumococcal Vaccines Work Group calls and via an email survey in which Work ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40459051/

Cost-effectiveness analysis of 20-valent pneumococcal ... Objective: The aim of the present study was to evaluate the cost-effectiveness of 20-valent pneumococcal conjugate vaccine (PCV20) compared to 13-valent ...

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

Efficacy of 20-Valent Pneumococcal Conjugate Vaccine ... The vaccine effectiveness of PCV20 against IPD and all-cause pneumonia was highest among individuals aged 65 to 74 years and decreased with ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590136225000762

A cost-effectiveness analysis of the 20-valent ... A cost-effectiveness analysis of the 20-valent pneumococcal conjugate vaccine for the prevention of pneumococcal disease among Mexican adults aged ≥60 years - ...

5. conferences.medicom-publishers.com conferences.medicom-publishers.com/specialisation/immunology/real-world-data-confirm-pcv20-effectiveness-against-pneumococcal-disease-in-adults-aged-%E2%89%A565-years/

Real-world data confirm PCV20 effectiveness against ... The vaccine effectiveness against invasive pneumococcal disease was 25.6% (95% CI 19.5-31.3) overall, with similar results across risk subgroups ...

6. 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 ...

7. cdc.gov cdc.gov/acip/grade/pneumo-PCV20-risk-based.html

20-valent pneumococcal conjugate vaccine (PCV20) for ... In October 2021, the ACIP recommended use of PCV20 for adults aged 19–64 years with certain underlying medical conditions or other risk factors ...

8. adult.prevnar20.com adult.prevnar20.com/safetyandsideeffects

Safety & Side Effects Learn about the safety risks, benefits and possible side effects of PREVNAR 20® (Pneumococcal 20-valent Conjugate Vaccine), a one-dose adult vaccine.

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

Post‑licensure Safety Surveillance of 20‑Valent ... On June 8, 2021, a new 20-valent pneumococcal conjugate vaccine (PCV20, PREVNAR 20®, Pfizer, Inc.) was licensed for use in adults aged ≥ 18 ...

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

Pneumococcal Vaccine Safety PCV20 helps protect against 20 types of pneumococcal bacteria that commonly cause severe illness among adults. Capvaxive (PCV21) in 2024 for use ...