PCV21 for Pneumonia Vaccine

Recruiting at 31 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Must not be taking: Immunosuppressants, Anticoagulants

Disqualifiers: Immunodeficiency, Seizures, Bleeding 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: 6

580 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new pneumonia vaccine, PCV21, to determine its safety and effectiveness in helping the body produce antibodies (proteins that fight germs). The study compares different vaccination schedules using both the new PCV21 and an existing 20-valent vaccine to identify the most effective approach for infants. Healthy babies born full-term or slightly early with stable health conditions may qualify for this trial. Participants will receive vaccinations at approximately 2, 4, 6, and between 12 to 15 months, with the study lasting about 19 months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking vaccine.

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

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

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

Research shows that PCV21, a vaccine designed to protect against 21 types of pneumococcal bacteria, is generally safe and well-tolerated. Several studies have demonstrated its good safety record. However, like many vaccines, it can sometimes cause side effects, such as redness or swelling at the injection site, fever, or irritability. Serious allergic reactions, like anaphylaxis, are rare but possible.

The FDA has approved the vaccine for use in adults to protect against serious pneumococcal infections, indicating it has passed strict safety checks. This approval offers reassurance about its safety, even as it undergoes testing in infants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard pneumonia vaccines, which typically use the 20-valent pneumococcal conjugate vaccine (20vPCV), the new PCV21 vaccine includes an additional serotype, potentially offering broader protection against pneumonia. Researchers are excited about PCV21 because it targets more strains of the bacteria responsible for pneumonia, which could lead to better prevention outcomes. This expanded coverage is what sets PCV21 apart from existing vaccines, addressing gaps in protection and aiming to reduce the incidence of pneumonia more effectively.

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

Research has shown that the PCV21 vaccine could help prevent more diseases caused by certain bacteria not covered by other vaccines. This trial will evaluate different vaccination schedules involving PCV21. Studies indicate that adding PCV21 to the vaccination schedule may reduce cases of serious infections like pneumonia. One study found that using PCV21 prevented tens of thousands of cases and deaths from pneumococcal disease. This suggests that PCV21 might offer broader protection than the current 20-valent pneumococcal vaccine by covering more bacterial strains. Overall, the evidence supports PCV21 as a strong option in fighting pneumococcal diseases. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 today.

I am considered healthy based on my recent medical exams.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive a series of vaccinations with either PCV21 or 20vPCV at approximately 2, 4, 6, and 12 to 15 months of age

13 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the last vaccination, including monitoring for serious adverse events and adverse events of special interest

6 months

What Are the Treatments Tested in This Trial?

Interventions

• PCV21

Trial Overview The study tests if the PCV21 vaccine is safe and effective in producing antibodies when given after doses of an already licensed 20-valent pneumococcal vaccine. Infants will receive vaccines at around 2, 4, 6, and 12-15 months old alongside routine pediatric vaccines.

How Is the Trial Designed?

Group I: Group 2: 20vPCV-20vPCV-PCV21-PCV21 Experimental Treatment 10 Interventions

Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA

Group II: Group 1: 20vPCV-PCV21-PCV21-PCV21 Experimental Treatment 10 Interventions

Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, PCV21 at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA

Group III: 20vPCV-20vPCV-20vPCV-PCV21 Experimental Treatment 10 Interventions

Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and PCV21 at 12 to 15 MoA

Group IV: 20vPCV-20vPCV-20vPCV-20vPCV Active Control 9 Interventions

Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and 20vPCV at 12 to 15 MoA

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

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]

In a randomized trial involving 1754 healthy infants, the 13-valent pneumococcal conjugate vaccine (PCV13) significantly reduced nasopharyngeal colonization of additional serotypes compared to the 7-valent vaccine (PCV7), indicating its enhanced efficacy.

PCV13 also elicited higher immune responses (IgG levels) for the additional serotypes, suggesting it may provide better protection against pneumococcal diseases than PCV7, while showing similar effectiveness for other common serotypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative immunogenicity and efficacy of 13-valent and 7-valent pneumococcal conjugate vaccines in reducing nasopharyngeal colonization: a randomized double-blind trial. Dagan, R., Patterson, S., Juergens, C., et al.[2022]

The 13-valent pneumococcal conjugate vaccine (PCV13) effectively induces strong antibody responses against both common and additional serotypes compared to the earlier 7-valent vaccine (PCV7), making it a valuable option for broader protection against pneumococcal disease.

PCV13 has a similar safety profile to PCV7 and is recommended for routine administration in infants and children, with flexible transition options for those already vaccinated with PCV7.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in pneumococcal disease prevention: 13-valent pneumococcal conjugate vaccine for infants and children. Paradiso, PR.[2011]

The Heptavalent pneumococcal conjugate vaccine (PCV-7) is currently the only approved vaccine for preventing invasive pneumococcal disease in children under two years old, demonstrating good safety when given alone or with other vaccines.

PCV-7 has been shown to be safe and effective in infants with HIV and those with sickle cell disease, highlighting its broad applicability in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of 7-valent pneumococcal conjugate vaccine. Ghaffar, F.[2007]

A large safety monitoring study involving 599,229 doses of the 13-valent pneumococcal vaccine (PCV13) found no increased risk of serious adverse events like febrile seizures or anaphylaxis in children aged 1 month to 2 years.

While no significant increased risk of adverse events was identified compared to the previous 7-valent vaccine (PCV7), a potential association with Kawasaki disease warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in children. Tseng, HF., Sy, LS., Liu, IL., et al.[2022]

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]

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 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]

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 introduction of pneumococcal conjugate vaccines (PCV7 and PCV13) in Israel led to a significant decline in hospitalization rates for community-acquired pneumonia among children aged 1 to 16 years, indicating the vaccines' effectiveness in preventing severe pneumonia cases.

There was a notable shift in pneumococcal serotype distribution, with vaccine-covered serotypes being isolated less frequently, suggesting that future vaccines may need to include additional serotypes to maintain their protective effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of pneumococcal conjugate vaccine on the prevalence and severity of hospitalizations for pneumonia in children. Eichler, N., Joseph, L., Megged, O., 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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11582112/

Cost-Effectiveness Analysis of the Use of V116, a 21- ... Based on the inputs and assumptions used, the results indicated that the V116 strategy prevented 27,766 and 32,387 disease cases/deaths and ...

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

Cost-effectiveness analysis of 21-valent pneumococcal ... In the 18–49 year age group, PCV21-contained serotypes accounted for 76.9 % (2015–2019) and 64 % (2022) of IPD isolates while PCV20-contained ...

4. merck.com merck.com/news/systematic-review-of-15-studies-focused-on-epidemiology-and-antimicrobial-resistance-of-pneumococcal-serotypes-covered-by-capvaxive-pneumococcal-21-valent-conjugate-vaccine-in-u-s-adults/

Systematic Review of 15 Studies Focused on ... CAPVAXIVE is Merck's 21-valent pneumococcal conjugate vaccine indicated for active immunization for the prevention of invasive disease and ...

5. cdc.gov cdc.gov/acip/downloads/slides-2024-10-23-24/03-Leidner-Pneumococcal-508.pdf

Summary of three economic analyses on the use of 21- ... Cost-effectiveness of an in-development adult-formulated 21-valent pneumococcal conjugate vaccine in US adults aged 50 years or older. Vaccine.

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. mayoclinic.org mayoclinic.org/drugs-supplements/pneumococcal-21-valent-conjugate-vaccine-intramuscular-route/description/drg-20571332

Pneumococcal 21-valent conjugate vaccine (intramuscular ... This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention.

8. capvaxive.com capvaxive.com/

CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine ... CAPVAXIVE is a vaccine specifically designed for adults that helps protect against IPD and pneumococcal pneumonia ... Important Safety Information Important ...

9. cdc.gov cdc.gov/acip/grade/pcv21-adults-19-and-older.html

21-valent Pneumococcal Conjugate Vaccine (PCV21) Use ... Included data relevant to the efficacy or effectiveness or immunogenicity and safety outcomes being measured. Pubmed, "V116" or "21-valent ...