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Vaccine. 2018 Oct 29;36(45):6883-6891. doi: 10.1016/j.vaccine.2018.02.113. Epub 2018 Sep 21.

Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants.

Author information

1
Soroka University Medical Center, Beer-Shiva, Israel.
2
Merck & Co., Inc., Kenilworth, NJ, USA.
3
University of Tampere, Tampere, Finland.
4
Pediatric Associates of Mt. Carmel, Cincinnati, OH, USA.
5
Cottonwood Pediatrics, Murray, UT, USA.
6
Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: luwy_musey@merck.com.

Abstract

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.

KEYWORDS:

Immunogenicity; Pneumococcal conjugate vaccine; Safety

PMID:
30244873
DOI:
10.1016/j.vaccine.2018.02.113
[Indexed for MEDLINE]

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