TY - JOUR
T1 - Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants
AU - Greenberg, David
AU - Hoover, Patricia A.
AU - Vesikari, Timo
AU - Peltier, Christopher
AU - Hurley, David C.
AU - McFetridge, Richard D.
AU - Dallas, Michael
AU - Hartzel, Jonathan
AU - Marchese, Rocio D.
AU - Coller, Beth Ann G.
AU - Stek, Jon E.
AU - Abeygunawardana, Chitrananda
AU - Winters, Michael A.
AU - MacNair, John E.
AU - Pujar, Narahari S.
AU - Musey, Luwy
N1 - Publisher Copyright:
© 2018 Elsevier Ltd
PY - 2018/10/29
Y1 - 2018/10/29
N2 - 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.
AB - 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.
KW - Immunogenicity
KW - Pneumococcal conjugate vaccine
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=85053702343&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2018.02.113
DO - 10.1016/j.vaccine.2018.02.113
M3 - Article
C2 - 30244873
AN - SCOPUS:85053702343
SN - 0264-410X
VL - 36
SP - 6883
EP - 6891
JO - Vaccine
JF - Vaccine
IS - 45
ER -