Safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine in healthy adults.
BACKGROUND
Pneumococcal disease remains an important health priority despite successful implementation of pneumococcal conjugate vaccines (PCVs) in infant immunization programs, mainly due to the emergence of diseases caused by serotypes not included in licensed PCVs. A 15-valent pneumococcal conjugate vaccine (PCV-15) containing the 7 serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) included in licensed PCV-7 available at study initiation plus 8 additional serotypes (1, 3, 5, 6A, 7F, 19A, 22F, 33F) was developed and evaluated in healthy adults 18-45 years of age.


METHODS
Sixty subjects received one dose of PCV-15 or PCV-7. Injection-site and systemic adverse events (AEs) were collected for 14-days postvaccination and serious AEs were collected for 30-days postvaccination. Safety laboratory tests (hematology, chemistry, and urinalysis) were evaluated prior to vaccination and 14-days postvaccination. Serotype-specific IgG and opsonophagocytic killing activity (OPA) responses to 15 serotypes included in PCV-15 were measured immediately prior to vaccination and 30-days postvaccination.


RESULTS
AE incidences were comparable between vaccine groups although numerically higher frequencies of erythema (33.3% versus 13.3%), swelling (50.0% versus 23.3%), and myalgia (63.3% versus 36.7%) were reported among PCV-15 versus PCV-7 recipients. Majority of AEs, irrespective of vaccine received, were transient and of mild-to-moderate intensity. No clinically significant differences were observed when comparing AE duration and severity. No laboratory abnormalities, vaccine-related SAEs or discontinuations from the study due to AEs were reported. IgG concentrations for the shared serotypes substantially increased postvaccination at comparable levels between recipients of PCV-15 and PCV-7. Substantial increases in antibody (IgG and OPA) responses to 8 serotypes unique to PCV-15 were observed in PCV-15 recipients. Slight increases to 2 serotypes unique to PCV-15, serotypes 6A and 19A, were also noted in PCV-7 recipients.


CONCLUSIONS
PCV-15 displays an acceptable safety profile and induces IgG and OPA responses to all serotypes included in the vaccine.
Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
Richard
R
McFetridge
Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
Ajoke Sobanjo-Ter
AS
Meulen
Clinical Research Center of Nevada, Las Vegas, NV, USA.
Steven D
SD
Folkerth
National Clinical Research - Richmond, Inc., Richmond, VA, USA.
John A
JA
Hoekstra
Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
Michael
M
Dallas
Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
Patricia A
PA
Hoover
Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
Rocio D
RD
Marchese
Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
Donna M
DM
Zacholski
Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
Wendy J
WJ
Watson
Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
Jon E
JE
Stek
Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
Jonathan S
JS
Hartzel
Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA. Electronic address: luwy_musey@merck.com.
Luwy K
LK
Musey
D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood*; D004311:Double-Blind Method; D004890:Erythema / Q000209:etiology; D005260:Female; D000069443:Heptavalent Pneumococcal Conjugate Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D008297:Male; D008875:Middle Aged; D063806:Myalgia / Q000209:etiology; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D065288:Serogroup; D013296:Streptococcus pneumoniae / Q000276:immunology*; D014611:Vaccination; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
D000907:Antibodies, Bacterial; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D007074:Immunoglobulin G; D022242:Pneumococcal Vaccines; D018074:Vaccines, Conjugate
Immunogenicity; Pneumococcal conjugate vaccine; Safety