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A Phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety,
Federico Martinon-Torres1, Jacek Wysocki2, Leszek Szenborn3
1Translational Pediatrics and Infectious Diseases, Pediatrics Department, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain; Genetics, Vaccines and Infections Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago, University of Santiago de Compostela, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.
Insights
The 15-valent pneumococcal conjugate vaccine (V114) demonstrated comparable safety and non-inferior immunogenicity to the 13-valent vaccine (PCV13) in infants. V114 showed superior immune responses for the two additional serotypes, supporting its routine use.
Area of Science:
- Immunology
- Vaccinology
- Pediatric Infectious Diseases
Background:
- The 15-valent pneumococcal conjugate vaccine (PCV) V114 includes all serotypes from the 13-valent PCV (PCV13) plus serotypes 22F and 33F.
- This study assessed the safety and immunogenicity of V114 compared to PCV13 in infants.
Purpose of the Study:
- To evaluate the safety and immunogenicity of V114 compared to PCV13 in healthy infants.
- To assess concomitant administration of V114 with DTPa-HBV-IPV/Hib and rotavirus RV1 vaccines.
Main Methods:
- A randomized controlled trial involving 1184 healthy infants randomized 1:1 to receive either V114 or PCV13.
- Vaccinations were administered on a 2+1 schedule (2, 4, and 11-15 months).
- Adverse events were monitored, and serotype-specific anti-pneumococcal IgG concentrations were measured at key time points.
Main Results:
- Proportions of participants experiencing solicited and serious adverse events were similar between V114 and PCV13 groups.
- V114 met non-inferiority criteria for 13 shared serotypes and superiority criteria for serotypes 22F and 33F.
- Concomitant vaccines (DTPa-HBV-IPV/Hib and RV1) showed non-inferior antibody responses when administered with V114.
Conclusions:
- V114 demonstrated non-inferior immunogenicity for shared serotypes and superior immunogenicity for novel serotypes compared to PCV13.
- The safety profile of V114 was comparable to PCV13.
- These findings support the routine use of V114 in infant immunization programs.
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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