Pneumococcal Vaccine for Pneumococcal Disease

Recruiting at 17 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

418 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing different versions of a pneumococcal vaccine to see if they are safe and effective. It involves adults aged 18-49 in the initial phase and adults aged 50 and older in the later phase. The vaccine helps the immune system fight off pneumococcal bacteria. A newer version of the vaccine is designed to protect against 20 different types of bacteria.

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.

What data supports the effectiveness of the treatment 20-valent pneumococcal conjugate vaccine (20vPnC) for preventing pneumococcal disease?

The 20-valent pneumococcal conjugate vaccine (PCV20) has been shown to provide protection against 20 different types of pneumococcal bacteria, expanding coverage beyond the previous 13-valent vaccine (PCV13). It has been approved for preventing pneumonia and invasive pneumococcal disease in both adults and children, indicating its effectiveness in reducing the disease burden. ^{1 2 3 4 5}

Is the 20-valent pneumococcal conjugate vaccine (Prevnar 20) safe for humans?

The 20-valent pneumococcal conjugate vaccine (Prevnar 20) has been evaluated for safety in both adults and children. It has been approved for use in adults since 2021 and in children since 2023, indicating that it has undergone safety assessments and is considered safe for these age groups. ^{1 3 4 6 7}

How is the 20-valent pneumococcal conjugate vaccine different from other pneumococcal vaccines?

The 20-valent pneumococcal conjugate vaccine (PCV20) is unique because it protects against 20 different types of the bacteria that cause pneumococcal disease, which is more than previous vaccines like the 13-valent version. This broader coverage can help prevent more cases of pneumonia and invasive diseases caused by these bacteria. ^{1 2 3 8 9}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: 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) and Phase 2(Stage 3).

Group II: 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) and Phase 2(Stage 3).

Group III: 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 IV: 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

Findings from Research

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]

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 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]

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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of 20-valent pneumococcal conjugate vaccine in Denmark compared with PPV23. [2022]

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

Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. [2015]

4. Netherlands 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. [2022]

5. Netherlands 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. [2022]

6. Netherlands 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. [2022]

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

Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine. [2015]

8. Australia pubmed.ncbi.nlm.nih.gov

Phase 1 trial of 13-valent pneumococcal conjugate vaccine in Japanese adults. [2016]

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

The impact of a 9-valent pneumococcal conjugate vaccine on the public health burden of pneumonia in HIV-infected and -uninfected children. [2022]