PCV21 Vaccine for Pneumonia
Recruiting in Palo Alto (17 mi)
+15 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Sanofi Pasteur, a Sanofi Company
Must not be taking: Immunosuppressants, Anticoagulants
Disqualifiers: Immunodeficiency, Seizure, Bleeding disorder, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
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.
12345How 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.
46789Eligibility 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
+12 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1: PCV21Experimental Treatment6 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: 20vPCVActive Control6 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Matrix Clinical Research - Huntington Park- Site Number : 8400012Huntington Park, CA
Matrix Clinical Research - Los Angeles- Site Number : 8400013Los Angeles, CA
PAS Research- Site Number : 8400002Tampa, FL
Snake River Research- Site Number : 8400060Idaho Falls, ID
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Sanofi Pasteur, a Sanofi CompanyLead Sponsor
References
Impact of pneumococcal conjugate vaccine on pneumonia hospitalization and mortality in children and elderly in Ecuador: Time series analyses. [2021]Pneumococcal conjugate vaccines (PCV) reduce the burden of invasive pneumococcal disease and pneumonia hospitalizations. However, there is limited evidence of the effect of PCVs on pneumonia mortality in children. It is anticipated that indirect effects resulting from PCV use among children might further reduce the remaining burden of adult pneumococcal disease caused by pneumococcal serotypes contained in PCV. Whether this will result in reduced pneumonia mortality in children and adults is still not known.
Humoral response to conjugate pneumococcal vaccine in paediatric oncology patients. [2019]Pneumococcal conjugate vaccine (PCV) is an effective way to prevent invasive pneumococcal diseases in high risk populations. The efficacy of this vaccine in paediatric oncology patients remains unknown.
Safety and effectiveness against respiratory tract infections for pneumococcal conjugate vaccine co-administered with routine vaccine combinations. [2015]Streptococcus pneumoniae is a major cause of bacterial pneumonia and other respiratory tract infections (RTI) in children. The heptavalent conjugated pneumococcal vaccine (PCV7) is offering a promising strategy against pneumococcal disease in children younger than 2 years. In this prospective epidemiological study in Germany, children between 2 and 6 months of age received in a 3:1 ratio a routine childhood vaccine combination with or without PCV7 according to a four-dose schedule. Five thousand nine hundred and eighty-four children were evaluable 1 year after the booster dose. Due to German guidelines children with underlying medical conditions were preferentially included into the PCV7 group and hence 66% of the children in the PCV7 group had at least one medical risk factor and 40% were preterm born compared to 18% and 6% in the control group. Overall PCV7 reduced respiratory tract infections by 10.5% (95% CI: 2.9-17.3%) and clinically diagnosed pneumonia by 6.3% (95% CI: -15.9 to 23.7%) in this unbalanced situation. In a propensity score matched pair analysis controlling for risk factors, effectiveness of PCV7 against pneumonia was 24.8% (95% CI: 0.9-43.1%). In children with at least one medical risk factor vaccine effectiveness against pneumonia was 38.4% (95% CI: 10.7-55.9%) compared to 10.9% (95% CI: -20.2 to 33.9%) without a risk factor. In preterm and term born children, PCV7 was well tolerated when simultaneously administered with widely used hexavalent routine vaccine combinations. The results demonstrate that PCV7 is safe and effective against RTI in preterm children and in children with comorbidities stressing the benefit of pneumococcal conjugate vaccine in these children at high risk for pneumococcal disease.
Thirteen-Valent Pneumococcal Conjugate Vaccine-Induced Immunoglobulin G (IgG) Responses in Serum Associated With Serotype-Specific IgG in the Lung. [2023]Pneumococcal conjugate vaccine (PCV) efficacy is lower for noninvasive pneumonia than invasive disease. In this study, participants were immunized with 13-valent PCV (PCV13) or hepatitis A vaccine (control). Bronchoalveolar lavage samples were taken between 2 and 6 months and serum at 4 and 7 weeks postvaccination. In the lung, anti-capsular immunoglobulin G (IgG) levels were higher in the PCV13 group compared to controls for all serotypes, except 3 and 6B. Systemically, IgG levels were elevated in the PCV13 group at 4 weeks for all serotypes, except serotype 3. IgG in bronchoalveolar lavage and serum positively correlated for nearly all serotypes. PCV13 shows poor immunogenicity to serotype 3, implying lack of protective efficacy. Clinical Trials Registration. ISRCTN 45340436.
Benefit of conjugate pneumococcal vaccination in preventing influenza hospitalization in children: a case-control study. [2013]The pneumococcal conjugate vaccine (PCV) might prevent hospitalizations in children because of the role of Streptococcus pneumoniae in the complications of influenza infection. We investigated the benefit of PCV vaccination in preventing influenza hospitalization in children
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]A 20-valent pneumococcal conjugate vaccine, PCV20, was developed to expand protection against vaccine-preventable pneumococcal disease. PCV20 contains the components of the 13-valent pneumococcal conjugate vaccine, PCV13, and includes capsular polysaccharide conjugates for 7 additional serotypes. Thus, PCV20 may cover those additional serotypes in individuals previously vaccinated with PCV13 or provide benefits of immunization with a conjugate vaccine to individuals previously immunized with a pneumococcal polysaccharide vaccine. This study described the safety and immunogenicity of PCV20 in adults ≥65 years of age with prior pneumococcal vaccination.
20-Valent Pneumococcal Conjugate Vaccine in Older People. [2023]Objective To review the current literature available regarding the efficacy and safety of the 20-valent pneumococcal vaccine in older people and summarize the current recommendation for use in this patient population. Data Sources PubMed was searched using the following terms: (PCV20 [Title] or 20-valent [Title] or 20-valent Pneumococcal conjugate vaccine [Title]) and English (Language). The current recommendations from the Advisory Committee on Immunization Practices and manufacturer package inserts were also reviewed. Study Selection/Data Extraction Nine articles on 20-valent Pneumococcal vaccine were identified based on the above search terms. Those selected for inclusion were randomized control trials including primary or subgroup analysis of PCV20 in older people. Data Synthesis Two randomized controlled trials have assessed the immunogenicity and safety of PCV20 in adults 65 years of age and older, one in a population previously vaccinated with PPSV23 and one in a vaccine-naive population. Both trials demonstrated PCV20 elicited a robust immune response one month after vaccination. PCV20 was well-tolerated with adverse events similar to earlier Pneumococcal vaccine formulations. Conclusion The simplified Pneumococcal vaccine regimen of a singular PCV20 vaccination offers a compelling advancement. Longer-term studies are needed to show if PCV20 will improve vaccination rates and reduce Pneumococcal morbidity and mortality.
Cost-effectiveness of an in-development adult-formulated pneumococcal vaccine in older US adults. [2023]CDC pneumococcal vaccination recommendations for older adults now include either 15- or 20-valent pneumococcal conjugate vaccine (PCV15/PCV20). However, an in-development 21-valent vaccine (PCV21), formulated based on adult pneumococcal disease epidemiology, could substantially increase coverage of disease-causing pneumococcal serotypes, particularly in Black older adults, who are at greater risk. The potential public health impact and cost-effectiveness of PCV21 compared to currently recommended vaccines in older adults is unclear.
The potential role for protein-conjugate pneumococcal vaccine in adults: what is the supporting evidence? [2022]Vaccination with protein-conjugate pneumococcal vaccine (PCV) provides children with extraordinary protection against pneumococcal disease, although the protective effect may be blunted by the emergence of replacement strains. Studies in adults have compared PCV with pneumococcal polysaccharide vaccine (PPV) using surrogate markers of protection, namely, serum anticapsular IgG antibody and opsonic activity. Results suggest that PCV is at least as effective as PPV for the strains covered, but a definitive and consistent advantage has not been demonstrated. Unfortunately, persons who are most in need of vaccine do not respond as well as otherwise healthy adults to either vaccine. Newer formulations of PCV will protect against the most prevalent of the current replacement strains, but replacement strains will create a moving target for PCVs. Unless an ongoing trial comparing 13-valent PCV with placebo (not to PPV) demonstrates a clearly better effect than that seen in the past with PPV, cost-effectiveness considerations are likely to prevent widespread use of PCV in adults.