Vaccine
MSD (UK) Limited, London, United Kingdom.
Published: May 2023
Background: V114 (15-valent pneumococcal conjugate vaccine [PCV]) contains all serotypes in 13-valent PCV (PCV13) and additional serotypes 22F and 33F. This study evaluated safety and immunogenicity of V114 compared with PCV13 in healthy infants, and concomitant administration with DTPa-HBV-IPV/Hib and rotavirus RV1 vaccines.
Methods: V114 and PCV13 were administered in a 2+1 schedule at 2, 4, and 11-15 months of age. Adverse events (AEs) were collected on Days 1-14 following each vaccination. Serotype-specific anti-pneumococcal immunoglobulin G (IgG) was measured 30 days post-primary series (PPS), immediately prior to a toddler dose, and 30 days post-toddler dose (PTD). Primary objectives included non-inferiority of V114 to PCV13 for 13 shared serotypes and superiority of V114 to PCV13 for the two additional serotypes.
Results: 1184 healthy infants 42-90 days of age were randomized 1:1 to V114 (n = 591) or PCV13 (n = 593). Proportions of participants with solicited AEs and serious AEs were comparable between vaccination groups. V114 met pre-specified non-inferiority criteria for all 13 shared serotypes, based on the difference in proportions of participants with serotype-specific IgG concentrations ≥0.35 μg/mL (response rate; lower bound of two-sided 95% confidence interval [CI] >-10.0) and IgG geometric mean concentration (GMC) ratios (lower bound of two-sided 95% CI >0.5), and pre-specified superiority criteria for serotypes 22F and 33F (lower bound of two-sided 95% CI >10.0 for response rates and >2.0 for GMC ratios). Antibody responses to DTPa-HBV-IPV/Hib and RV1 vaccines met pre-specified non-inferiority criteria, based on antigen-specific response rates to DTPa-HBV-IPV/Hib and anti-rotavirus IgA geometric mean titers.
Conclusions: After a 2+1 schedule, V114 elicited non-inferior immune responses to 13 shared serotypes and superior responses to the two additional serotypes compared with PCV13, with comparable safety profile. These results support the routine use of V114 in infants.
Trial Registration: ClinicalTrials.gov: NCT04031846; EudraCT: 2018-003787-31.
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http://dx.doi.org/10.1016/j.vaccine.2023.04.036 | DOI Listing |
Vaccine
January 2025
Department of Pediatrics, Section of Infectious Diseases and Global Health, Yale University School of Medicine, New Haven, CT, United States; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States; Yale Institute for Global Health, Yale University, New Haven, CT, United States; Yale Center for Infection and Immunity, Yale University, New Haven, CT, United States. Electronic address:
Background: Pneumococcal conjugate vaccines (PCV) reduced invasive disease, but the overall prevalence of pneumococcal nasopharyngeal colonization among children has not changed significantly. Our knowledge of which serotypes, once colonized, hold a higher likelihood to cause invasive disease is limited.
Methods: Serotype-specific invasive capacity (IC) of Streptococcus pneumoniae was estimated using an enhanced population-based invasive pneumococcal disease (IPD) surveillance in children <7 years of age in Massachusetts and surveillance of nasopharyngeal (NP) colonization in selected Massachusetts communities in corresponding respiratory seasons.
Vaccines (Basel)
December 2024
Henan Province Center for Disease Control and Prevention, Zhengzhou 450003, China.
Objectives: This study aimed to evaluate the immunogenicity and safety of a 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197/TT) (PCV13i) in infants.
Methods: A total of 1200 infants were randomly assigned to either the experimental PCV13i group or the control PCV13 group in a 1:1 ratio. Each group received a three-dose series of the vaccine at 2, 4, and 6 months of age, followed by a booster dose at 12-15 months.
Open Forum Infect Dis
January 2025
Vaccines, Pfizer Inc, Collegeville, Pennsylvania, USA.
Background: Serotype-specific urinary antigen detection (UAD) assay results can be used to estimate the serotype contribution among adults with pneumococcal community-acquired pneumonia (CAP) and to guide recommendations regarding higher-valency pneumococcal conjugate vaccines (PCVs).
Methods: Adults aged ≥18 years hospitalized with radiographic evidence of CAP were prospectively enrolled in 4 US cities from November 2019 to December 2020, overlapping the coronavirus disease 2019 (COVID-19) pandemic. Data were collected by patient interview and medical chart review.
NPJ Vaccines
December 2024
Department for Evidence-based Medicine and Evaluation, University for Continuing Education Krems (Danube University Krems), Krems, Austria.
Pneumococcal infections are a serious health issue associated with increased morbidity and mortality. This systematic review evaluated the efficacy, effectiveness, immunogenicity, and safety of the pneumococcal conjugate vaccine (PCV)15 compared to other pneumococcal vaccines or no vaccination in children and adults. We identified 20 randomized controlled trials (RCTs).
View Article and Find Full Text PDFVaccine
December 2024
Department of Pharmacotherapy, University of Utah College of Pharmacy, Salt Lake City, UT, USA; IDEAS Center, Veterans Affairs Salt Lake City Healthcare System, Salt Lake City, UT, USA. Electronic address:
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