PCV21 Vaccine for Pneumococcal Infections

Not currently recruiting at 43 trial locations

Overseen By Clinical Sciences & Operations Study Director & Operations Study Director

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi Pasteur, a Sanofi Company

Must not be taking: Immunosuppressants, Corticosteroids, Anticoagulants, others

Disqualifiers: Immunodeficiency, Seizures, Neurological disorders, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-11 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new vaccine, PCV21, to assess its safety and effectiveness in boosting immunity against pneumococcal infections. It targets infants, toddlers, and children up to 17 years old who have not received similar vaccines. The trial involves administering shots at different intervals based on age. Healthy children and teens who have not been vaccinated against S. pneumoniae may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking vaccine.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot receive any vaccines 4 weeks before or after the study vaccine, except for certain flu vaccines. Also, if you are between 2 to 17 years old, you should not have taken antibiotics within 72 hours before the first blood draw.

Is there any evidence suggesting that the PCV21 vaccine is likely to be safe for humans?

Research has shown that the PCV21 vaccine is safe for people. Studies with over 4,000 participants compared the safety of PCV21 to other vaccines like PCV15 and PCV20, finding no major safety issues with PCV21. Most participants handled the vaccine well, with very few serious side effects reported.

Another study found that PCV21 effectively triggers the body's immune response to protect against disease without causing safety problems. Since PCV21 is similar to already approved vaccines, this supports its safety. Overall, past research suggests that PCV21 is safe for children and teenagers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pneumococcal infections?

Researchers are excited about the PCV21 vaccine for pneumococcal infections because it offers a broader protective range against more types of pneumococcal bacteria compared to existing vaccines like PCV13 and PPSV23. This could potentially result in better prevention of pneumococcal diseases in infants, toddlers, and children. Unlike current options, PCV21 aims to cover additional strains of the bacteria, which may lead to a more comprehensive shield against infections. Furthermore, the vaccine is administered in a series of doses tailored to different age groups, optimizing the immune response based on developmental needs.

What evidence suggests that the PCV21 vaccine could be effective for pneumococcal infections?

Research shows that the PCV21 vaccine protects against more types of bacteria causing pneumococcal infections than current vaccines. Studies indicate that adding PCV21 to available vaccines is expected to prevent more diseases caused by these bacteria. In adults aged 19–49 with certain health risks, PCV21 provided slightly better protection compared to PCV20, with coverage rates of 72.3% versus 69.2%. This wider protection suggests that PCV21 could more effectively reduce pneumococcal diseases, including serious illnesses like pneumonia and meningitis. While most research focuses on adults, this trial will evaluate PCV21's effectiveness in children and teenagers, with different dosing schedules for infants, toddlers, and older children. ^{4 6 7 8 9}

Who Is on the Research Team?

Clinical Sciences & Operations Study Director

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

This trial is for healthy infants, toddlers, children, and adolescents aged 7 months to 17 years who were born at full term or preterm but stable. Adolescents must agree to use effective contraception or abstain from sexual activity during the study period. Consent forms are required.

Inclusion Criteria

I am of a specific age.

I am considered healthy based on my recent medical exams.

I fit the specific participant and disease requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intramuscular injections of the pneumococcal vaccine according to age group: 1 injection for children/adolescents, 2 injections for toddlers, and 3 injections for infants

6-11 months

Multiple visits for each injection

Follow-up

Participants are monitored for safety and immunogenicity, including serotype-specific IgG concentrations and OPA titers

1 month after last vaccination

What Are the Treatments Tested in This Trial?

Interventions

• PCV21

Trial Overview The study compares the safety and immune response of a new pneumococcal vaccine (PCV21) with an existing one (20vPCV). It's designed for those who need catch-up vaccinations across different age groups: infants, toddlers, children, and adolescents.

How Is the Trial Designed?

Group I: Toddlers (12 to 23 MoA) Experimental Treatment 2 Interventions

Participants will receive 2 intramuscular injections of the pneumococcal vaccine with an interval of 8 to 12 weeks (56 to 84 days) between doses

Group II: Infants (7 to 11 MoA) Experimental Treatment 2 Interventions

Participants will receive 3 intramuscular injections of pneumococcal vaccine with an interval of: * 4 to 8 weeks (28 to 56 days) between the 1st dose and the 2nd dose * 8 to 12 weeks (56 to 84 days) between the 2nd dose and the 3rd dose AND age ≥ 12 MoA at 3rd dose

Group III: Children/adolescent (2 to 5 and 6 to 17 YoA) Experimental Treatment 2 Interventions

Participants will receive 1 intramuscular injection of the pneumococcal vaccine

Who Is Running the Clinical Trial?

Sanofi Pasteur, a Sanofi Company

Lead Sponsor

Trials

429

Recruited

6,140,000+

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences

Published Research Related to This Trial

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]

A study analyzing data from Finnish population registers found no significant increase in adverse events after the introduction of the ten-valent Pneumococcal Conjugate Vaccine (PCV10) in children, except for a higher incidence of urticarial rash, which was attributed to changes in healthcare coding rather than the vaccine itself.

The findings suggest that public health concerns regarding adverse events linked to PCV10 are unfounded, highlighting the effectiveness of using real-world data for validating safety signals in vaccination programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Register-Based Ecologic Evaluation of Safety Signals Related to Pneumococcal Conjugate Vaccine in Children. Artama, M., Rinta-Kokko, H., Nohynek, H., et al.[2018]

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]

A systematic review of 42 studies found that the 7-valent pneumococcal conjugate vaccine (PCV7) is generally safe, with mild and self-limited local reactions and fever, but no increased risk of severe side effects.

While some studies indicated a potential link between pneumococcal vaccines and an increased risk of hospitalization for reactive airway disease, the overall safety profile of PCV7 remains favorable, warranting further investigation into this specific concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of pneumococcal conjugate vaccines: systematic review of pre- and post-licensure data. Destefano, F., Pfeifer, D., Nohynek, H.[2021]

The 20-valent pneumococcal conjugate vaccine (PCV20) was found to be safe and well tolerated, with no significant safety concerns reported in a phase 3 study involving adults across three age groups (18-49, 50-59, and ≥60 years).

PCV20 demonstrated comparable immunogenicity to the 13-valent PCV (PCV13) and the 23-valent polysaccharide vaccine (PPSV23), effectively inducing immune responses to all 20 vaccine serotypes, which suggests it could provide broader protection against pneumococcal disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pivotal Phase 3 Randomized Clinical Trial of the Safety, Tolerability, and Immunogenicity of 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥18 Years. Essink, B., Sabharwal, C., Cannon, K., et al.[2022]

The in-development 21-valent pneumococcal vaccine (PCV21) is projected to be more cost-effective and clinically beneficial than the currently recommended 15- or 20-valent vaccines for older adults, particularly for Black older adults who are at higher risk for pneumococcal disease.

In a Markov decision model analysis involving 65-year-old cohorts, PCV21 showed favorable cost-effectiveness ratios of $88,478 per quality-adjusted life-year (QALY) for Black individuals and $127,436/QALY for non-Black individuals, suggesting that PCV21 could justify a future recommendation for broader use in older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of an in-development adult-formulated pneumococcal vaccine in older US adults. Wateska, AR., Nowalk, MP., Lin, CJ., et al.[2023]

Pneumococcal conjugate vaccines (PCV7 and PCV9) are highly immunogenic and effective, with PCV7 showing 82-97% efficacy against invasive pneumococcal disease and 90% against pneumococcal pneumonia, based on various randomized controlled trials.

PCVs are generally safe and well-tolerated, even when given alongside other childhood vaccines, and studies suggest that fewer doses (2+1 schedule) can achieve similar protective immunity as the standard 3+1 schedule.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity, efficacy, safety and effectiveness of pneumococcal conjugate vaccines (1998-2006). Oosterhuis-Kafeja, F., Beutels, P., Van Damme, P.[2022]

The introduction of the seven-valent pneumococcal vaccine has led to significant declines in invasive pneumococcal disease and antibiotic-resistant infections in children, demonstrating its efficacy and safety.

Newer pneumococcal conjugate vaccines (PHiD-CV and PCV-13) are being developed to provide broader coverage, particularly in developing countries, while ongoing research is exploring alternative vaccine strategies based on pneumococcal proteins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pneumococcal conjugated vaccines: impact of PCV-7 and new achievements in the postvaccine era. Dinleyici, EC., Yargic, ZA.[2008]

The protein-conjugate pneumococcal vaccine (PCV) offers strong protection against pneumococcal disease in children, but its effectiveness may be reduced by the emergence of new replacement strains.

Current evidence suggests that PCV is at least as effective as the pneumococcal polysaccharide vaccine (PPV) in adults, but those most in need of vaccination often have a weaker response, raising concerns about the cost-effectiveness of widespread PCV use in adult populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential role for protein-conjugate pneumococcal vaccine in adults: what is the supporting evidence? Musher, DM., Sampath, R., Rodriguez-Barradas, MC.[2022]

Citations

1. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7336a3.htm

Use of 21-Valent Pneumococcal Conjugate Vaccine .. ... Adding PCV21 as an option in the current PCV recommendation is expected to prevent additional disease caused by pneumococcal serotypes unique to ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40270275/

Economic evaluation of PCV21 in vaccine-naïve adults ... Key outcome measures included undiscounted clinical cases: invasive pneumococcal disease (IPD), inpatient and outpatient non-bacteremic pneumococcal pneumonia ( ...

3. ajpmonline.org ajpmonline.org/article/S0749-3797(25)00627-0/fulltext

What About Vaccine-Experienced Younger Adults? Cost ... Among 50-64 year-olds, compared with PPSV23, the ICER of PCV21 was $62,400/QALY in PCV13-experienced and $85,400 in PCV15-experienced. PCV21 was ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25002828

Cost-effectiveness analysis of 21-valent pneumococcal ... When indirect effects from PCV15 and serotype replacement were included, PCV21 was cost-effective for IC and unhoused populations, while PCV20 ...

5. academic.oup.com academic.oup.com/jac/article/80/5/1377/8093164

Comparing serotype coverage of pneumococcal vaccines with ... In adults aged 19–49 years with certain risk conditions for pneumococcal disease, PCV20 and PCV21 (V116) coverage was similar at 69.2% and 72.3% ...

6. merckvaccines.com merckvaccines.com/capvaxive/

CAPVAXIVE® (Pneumococcal 21-valent Conjugate ... CAPVAXIVE is the only FDA-approved pneumococcal conjugate vaccine that helps protect against serotypes responsible for ~84% of invasive pneumococcal disease ...

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

Pneumococcal Vaccine Safety PCV21 helps protect against eight new types of pneumococcal bacteria that commonly cause severe illness in adults and are not included in other ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40833801/

Safety and Immunogenicity of a Pneumococcal Conjugate ... Conclusion: PCV21 demonstrated favorable immunogenicity, with no safety concerns identified. This study supports the evaluation of the PCV21 formulation that ...

9. vaccinesafety.edu vaccinesafety.edu/pneumococcal/

Pneumococcal Three pneumococcal conjugate vaccines are licensed and recommended for use in the United States: PCV15, PCV20 and PCV21. Previous versions of pneumococcal ...