Pneumococcal Vaccine for Pneumonia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine, PCV21, to determine if it can safely help infants build immunity against pneumonia compared to an already approved vaccine. The researchers will administer the vaccine alongside regular baby shots to assess its effectiveness in creating antibodies, the body's defense against germs. Full-term and preterm infants who are healthy and born at a medically stable weight may qualify for this trial. Participants will attend visits over approximately 20 months to receive the vaccine and monitor their health. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking vaccine for infants.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy, long-term corticosteroids, or have received certain vaccines recently, 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 the PCV21 vaccine is generally well-tolerated. Earlier studies found mostly mild and temporary side effects, such as soreness at the injection site and mild fever, with serious side effects being rare.
The PCV21 vaccine is being compared to the 15-valent pneumococcal vaccine (Vaxneuvance), which the FDA has approved for use in babies, indicating well-documented safety. Since PCV21 is in a Phase 3 trial, earlier studies have already tested its safety, revealing no major safety concerns so far.
Overall, the available data suggest that both vaccines are expected to be safe for use in babies.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the PCV21 vaccine because it targets a broader range of pneumococcal strains compared to existing pneumococcal vaccines like PCV13 and PPSV23. This means it has the potential to offer better protection against pneumonia caused by diverse strains of the bacteria. Additionally, PCV21 is administered alongside other vaccines such as Hexyon, MMRVaxPro, and Varivax, which could streamline the immunization process for infants. Most importantly, the PCV21 vaccine is designed to be effective even in preterm infants, offering a tailored dosing schedule to enhance protection in this vulnerable group.
What evidence suggests that this trial's vaccines could be effective for pneumonia?
Research has shown that the PCV21 vaccine, which participants in this trial may receive, can help prevent more diseases caused by certain types of pneumococcal bacteria not covered by other vaccines. Studies have found that PCV21 significantly reduces serious infections like pneumonia. This vaccine has successfully lowered the number of cases and deaths from these diseases, especially in adults. Although most research focuses on older people, the aim remains the same for infants: to strengthen their immune systems to better fight these infections by producing antibodies, which are proteins that combat germs. Therefore, PCV21 appears promising in boosting protection against pneumonia and related infections. Meanwhile, another group in this trial will receive the 15vPCV vaccine, which is also under study for its effectiveness in preventing pneumococcal diseases in infants.678910
Are You a Good Fit for This Trial?
This trial is for healthy infants aged approximately 2 months (42 to 112 days) at the time of inclusion. The study seeks participants who are in good health as confirmed by a medical evaluation, which includes their medical history and physical examination.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the study vaccines (PCV21 or 15vPCV) at approximately 2, 4, and 11 to 15 months of age, or at 2, 3, 4, and 11 to 15 months of age for preterm infants, co-administered with routine pediatric vaccines.
Follow-up
Participants are monitored for safety and effectiveness after the last vaccine injection, including monitoring for serious adverse events and antibody responses.
Long-term monitoring
Participants are monitored for adverse events of special interest and other safety outcomes throughout the study duration.
What Are the Treatments Tested in This Trial?
Interventions
- PCV21 vaccine
Trial Overview
The trial is testing the safety and ability of a new vaccine called PCV21 to stimulate an immune response compared to an existing vaccine, Vaxneuvance. Infants will receive these vaccines alongside routine pediatric shots according to local recommendations over a period up to about 20 months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will be administered via intramuscular injection (IM) a 2-dose primary series of PCV21 at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of PCV21 co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice
Participants will be administered via intramuscular injection (IM) a 2-dose primary series of 15vPCV at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of 15vPCV co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice
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Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
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
Citations
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 ...
Cost-Effectiveness Analysis of the Use of V116, a 21- ...
The use of PCV21 by PCV-naïve adults aged ≥65 would markedly reduce the burden of adult pneumococcal disease, making substantial contributions ...
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 ...
Cost-effectiveness analysis of 21-valent pneumococcal ...
The two-way sensitivity analysis revealed that the price per dose of PCV21 should be reduced by at least 7 % for the unhoused, 12 % for IC and ...
Economic evaluation of PCV21 in vaccine-naïve adults ...
The findings revealed that the PCV21 strategy resulted in fewer cases of pneumococcal disease (PD) and related fatalities when compared to the recommended ...
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 ...
Use of 21-Valent Pneumococcal Conjugate Vaccine Among ...
PCV21 Safety Safety data from four PCV21 phase III clinical trials (11,13–15) were pooled for the following participants: pneumococcal vaccine– ...
Pneumococcal
The safety of PPSV23 vaccine in pregnancy has not been studied. However, no adverse outcomes have been reported among newborns whose mothers were inadvertently ...
CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine ...
CAPVAXIVE is a vaccine for individuals 18 years of age and older to help protect against invasive pneumococcal disease and pneumonia caused by certain types of ...
10.
va.gov
va.gov/formularyadvisor/DOC_PDF/MON_Pneumococcal_vaccine_PCV21_CAPVAXIVE_monograph_Nov_2024.pdfPneumococcal 21-valent conjugate vaccine (CAPVAXIVE) ...
Data from the CDC from 2018-2022 noted that PCV21 covered 85% coverage of serotypes responsible for IPD compared to 54% with PCV20 in those aged ≥ 65 years. In ...
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