PCV21 Vaccine for Pneumonia

Recruiting at 71 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi Pasteur, a Sanofi Company

Must not be taking: Immunosuppressants, Anticoagulants

Disqualifiers: Immunodeficiency, Seizure, Bleeding disorder, 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: 6

Duration: 15 months

1630 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a Phase 3, randomized, modified double-blind study which aims to measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20-valent pneumococcal vaccine (Prevnar 20, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines in infants aged from approximately 2 months (42 to 89 days). The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20-valent pneumococcal vaccines) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given at the same timepoints. There will be 6 study visits: -Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications. However, if you are on immunosuppressive therapy, long-term systemic corticosteroids, or have received certain vaccines recently, you may not be eligible to participate.

What data supports the effectiveness of the PCV21 vaccine treatment for pneumonia?

Research on similar pneumococcal conjugate vaccines, like PCV7 and PCV13, shows they can reduce respiratory infections and pneumonia in children, especially those with medical risk factors. These vaccines have been effective in reducing pneumonia hospitalizations and complications from infections like influenza. ^{1 2 3 4 5}

How does the PCV21 vaccine differ from other pneumonia treatments?

The PCV21 vaccine is unique because it is designed to cover more pneumococcal serotypes than existing vaccines, potentially increasing protection, especially in Black older adults who are at higher risk. This expanded coverage could make it more effective than current vaccines like PCV20 or PCV13. ^{4 6 7 8 9}

Eligibility Criteria

This trial is for healthy infants aged approximately 2 months (42 to 89 days) at the time of inclusion. They must be deemed healthy by a medical evaluation, which includes their medical history and physical examination.

Inclusion Criteria

I am between 42 and 89 days old.

I am considered healthy based on my recent medical exams.

I was born full-term or preterm but stable and met the weight criteria.

Exclusion Criteria

I have received immune globulins, blood, or blood products since birth.

I have a weak immune system or have been on long-term steroids or cancer treatment.

Any contraindication to the routine pediatric vaccines being administered in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 4-dose regimen of either PCV21 or 20vPCV vaccine at approximately 2, 4, 6, and 12 to 15 months of age, co-administered with routine pediatric vaccines.

15 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the last vaccine dose, including assessment of antibody concentrations and adverse events.

6 months

Treatment Details

Interventions

• PCV21 vaccine

Trial Overview The study tests if the PCV21 vaccine is safe and effective in producing antibodies compared to the Prevnar 20 vaccine when given alongside routine pediatric vaccines over a period of up to about 19 months with six scheduled visits.

Participant Groups

Group I: Group 1: PCV21 Experimental Treatment 6 Interventions

Participants will be administered via intramuscular injection (IM) a 3-dose primary series of PCV21 at approximately 2, 4 and 6 months of age (MoA) co- administered with Vaxelis or Hexaxim (for participants included in South Korea only) and RotaTeq. At toddler age (12 to 15 MoA), a 4th dose of PCV21 will be administered concomitantly with a single dose of M-M-M-R II and Varivax.

Group II: Group 2: 20vPCV Active Control 6 Interventions

Participants will be administered via intramuscular injection (IM) a 3-dose primary series of 20vPCV at approximately 2, 4 and 6 months of age (MoA) co- administered with Vaxelis or Hexaxim (for participants included in South Korea only) and RotaTeq. At toddler age (12 to 15 MoA), a 4th dose of 20vPCV will be administered concomitantly with a single dose of M-M-M-R II and Varivax.

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

Findings from Research

The introduction of pneumococcal conjugate vaccines (PCV) in Ecuador led to a significant reduction in pneumonia hospitalizations among children under 5 years, with a 33% decrease observed in this age group.

PCV also contributed to a reduction in pneumonia mortality, with a 14% decrease in children under 1 year and a 22% decrease in adults aged 50-64 years, highlighting its potential impact on both pediatric and adult populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of pneumococcal conjugate vaccine on pneumonia hospitalization and mortality in children and elderly in Ecuador: Time series analyses. Jimbo Sotomayor, R., Toscano, CM., Sánchez Choez, X., et al.[2021]

In a study of 44 pediatric oncology patients, the heptavalent pneumococcal conjugate vaccine (PCV-7) resulted in protective antibody levels against all seven targeted serotypes, with increases in antibody concentrations ranging from 3.8-fold to 85.8-fold.

No cases of invasive pneumococcal disease were reported among the patients during the study, indicating that PCV-7 is effective in eliciting a strong immune response in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Humoral response to conjugate pneumococcal vaccine in paediatric oncology patients. Cheng, FW., Ip, M., Chu, YY., et al.[2019]

In a study of 5,984 children aged 2 to 6 months, the heptavalent conjugated pneumococcal vaccine (PCV7) reduced respiratory tract infections by 10.5% and pneumonia by 6.3%, demonstrating its effectiveness in preventing these conditions.

PCV7 showed even greater effectiveness against pneumonia in children with medical risk factors, achieving a 38.4% reduction, and was found to be safe when given alongside other routine vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness against respiratory tract infections for pneumococcal conjugate vaccine co-administered with routine vaccine combinations. Adam, D., Fehnle, K.[2015]

The 13-valent pneumococcal conjugate vaccine (PCV13) was found to generate higher levels of anti-capsular immunoglobulin G (IgG) in the lungs compared to a control vaccine, indicating a strong local immune response for most serotypes.

However, PCV13 showed poor immunogenicity for serotype 3, suggesting that it may not provide adequate protection against this specific strain of pneumonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thirteen-Valent Pneumococcal Conjugate Vaccine-Induced Immunoglobulin G (IgG) Responses in Serum Associated With Serotype-Specific IgG in the Lung. Mitsi, E., McLenaghan, D., Wolf, AS., et al.[2023]

In a study involving 194 hospitalized children with influenza and 342 matched controls, the pneumococcal conjugate vaccine (PCV) significantly reduced hospitalizations by 48% during the 2009-2010 pandemic wave for fully vaccinated children under 5 years old.

However, during the 2010-2011 influenza season, the study found no significant benefit of PCV vaccination in preventing hospitalizations, indicating that the effectiveness of the vaccine may vary by season.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit of conjugate pneumococcal vaccination in preventing influenza hospitalization in children: a case-control study. Domínguez, A., Castilla, J., Godoy, P., et al.[2013]

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]

The 20-valent pneumococcal vaccine (PCV20) has been shown to elicit a strong immune response in older adults (65 years and older) one month after vaccination, based on two randomized controlled trials.

PCV20 is well-tolerated, with adverse events comparable to previous pneumococcal vaccines, suggesting it is a safe option for older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

20-Valent Pneumococcal Conjugate Vaccine in Older People. Sewell, HE., Conway, S., Douglas, C.[2023]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of pneumococcal conjugate vaccine on pneumonia hospitalization and mortality in children and elderly in Ecuador: Time series analyses. [2021]

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

Humoral response to conjugate pneumococcal vaccine in paediatric oncology patients. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and effectiveness against respiratory tract infections for pneumococcal conjugate vaccine co-administered with routine vaccine combinations. [2015]

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

Thirteen-Valent Pneumococcal Conjugate Vaccine-Induced Immunoglobulin G (IgG) Responses in Serum Associated With Serotype-Specific IgG in the Lung. [2023]

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

Benefit of conjugate pneumococcal vaccination in preventing influenza hospitalization in children: a case-control study. [2013]

6. 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]

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

20-Valent Pneumococcal Conjugate Vaccine in Older People. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of an in-development adult-formulated pneumococcal vaccine in older US adults. [2023]

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

The potential role for protein-conjugate pneumococcal vaccine in adults: what is the supporting evidence? [2022]