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Updated: Feb 4, 2026

Experimental Human Pneumococcal Carriage
Published on: February 15, 2013
Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants
David Greenberg1, Patricia A Hoover2, Timo Vesikari3
1Soroka University Medical Center, Beer-Shiva, Israel.
Insights
The 15-valent pneumococcal conjugate vaccine (PCV15) showed a safety profile comparable to PCV13 in infants. PCV15 induced robust immune responses to all 15 serotypes, demonstrating its potential for broader protection against pneumococcal disease.
Area of Science:
- Immunology
- Vaccinology
- Pediatric Infectious Diseases
Background:
- Pneumococcal conjugate vaccines (PCV) have reduced disease burden but led to increased disease from non-vaccine serotypes.
- Evaluating new vaccines is crucial to broaden protection against emerging pneumococcal serotypes.
Purpose of the Study:
- To assess the safety and immunogenicity of a 15-valent pneumococcal conjugate vaccine (PCV15) in infants.
- To compare PCV15, including novel serotypes 22F and 33F, against the existing 13-valent PCV (PCV13).
Main Methods:
- Infants received PCV15 (adjuvanted or nonadjuvanted) or PCV13 at 2, 4, 6, and 12-15 months.
- Safety was monitored for 14 days post-vaccination.
- Immunogenicity assessed via IgG GMCs and OPA GMTs at multiple time points.
Main Results:
- Safety profiles were similar across all vaccine groups.
- PCV15 demonstrated non-inferiority to PCV13 for 10 of 13 shared serotypes based on IgG GMCs.
- PCV15 induced higher antibody responses to serotypes 3, 22F, and 33F compared to PCV13.
Conclusions:
- PCV15 exhibits an acceptable safety profile in infants.
- The vaccine elicits robust immune responses (IgG and OPA) to all 15 serotypes.
- PCV15 offers comparable immunogenicity to PCV13 for most shared serotypes, with enhanced responses to new serotypes.
Background:
Pediatric use of pneumococcal conjugate vaccines (PCV) has been associated with significant decrease in disease burden. However, disease caused by non-vaccine serotypes has increased. Safety and immunogenicity of 15-valent PCV (PCV15) containing serotypes included in 13-valent PCV (PCV13) plus serotypes 22F and 33F were evaluated in infants (NCT01215188).
Methods:
Infants received adjuvanted PCV15, nonadjuvanted PCV15, or PCV13 at 2, 4, 6, and 12-15 months of age. Safety was monitored for 14 days after each dose. Serotype-specific IgG geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured at postdose-3, predose-4, and postdose-4.
Results:
Safety profiles were comparable across vaccination groups. At postdose-3, both PCV15 formulations were non-inferior to PCV13 for 10 of 13 shared serotypes but failed non-inferiority for 3 serotypes (6A, 6B, and 19A) based on proportion of subjects achieving IgG GMC ≥0.35 µg/mL. Adjuvanted PCV15 and nonadjuvanted PCV15 were non-inferior to PCV13 for 11 and 8 shared serotypes, respectively, based on postdose 3 comparisons of GMC ratios. PCV15 induced higher antibodies to serotypes 3, 22F, and 33F than PCV13.
Conclusions:
PCV15 displayed acceptable safety profile and induced IgG and OPA to all 15 vaccine serotypes at levels comparable to PCV13 for 10 of 13 shared serotypes. Study identification: V114-003. CLINICALTRIALS.GOV identifier: NCT01215188.
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