PMID- 25913828
OWN - NLM
STAT- MEDLINE
DCOM- 20160419
LR  - 20220408
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 33
IP  - 24
DP  - 2015 Jun 4
TI  - Safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate 
      vaccine in healthy adults.
PG  - 2793-9
LID - S0264-410X(15)00478-8 [pii]
LID - 10.1016/j.vaccine.2015.04.025 [doi]
AB  - 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. CONCLUSION: PCV-15 displays an acceptable safety profile and induces 
      IgG and OPA responses to all serotypes included in the vaccine.
CI  - Copyright (c) 2015 Elsevier Ltd. All rights reserved.
FAU - McFetridge, Richard
AU  - McFetridge R
AD  - Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
FAU - Meulen, Ajoke Sobanjo-Ter
AU  - Meulen AS
AD  - Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
FAU - Folkerth, Steven D
AU  - Folkerth SD
AD  - Clinical Research Center of Nevada, Las Vegas, NV, USA.
FAU - Hoekstra, John A
AU  - Hoekstra JA
AD  - National Clinical Research - Richmond, Inc., Richmond, VA, USA.
FAU - Dallas, Michael
AU  - Dallas M
AD  - Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
FAU - Hoover, Patricia A
AU  - Hoover PA
AD  - Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
FAU - Marchese, Rocio D
AU  - Marchese RD
AD  - Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
FAU - Zacholski, Donna M
AU  - Zacholski DM
AD  - Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
FAU - Watson, Wendy J
AU  - Watson WJ
AD  - Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
FAU - Stek, Jon E
AU  - Stek JE
AD  - Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
FAU - Hartzel, Jonathan S
AU  - Hartzel JS
AD  - Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
FAU - Musey, Luwy K
AU  - Musey LK
AD  - Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA. Electronic address: 
      luwy_musey@merck.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT01215175
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150423
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Heptavalent Pneumococcal Conjugate Vaccine)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Pneumococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antibodies, Bacterial/*blood
MH  - Double-Blind Method
MH  - Erythema/etiology
MH  - Female
MH  - Heptavalent Pneumococcal Conjugate Vaccine/administration & dosage/adverse 
      effects/immunology
MH  - Humans
MH  - Immunoglobulin G/blood
MH  - Male
MH  - Middle Aged
MH  - Myalgia/etiology
MH  - Pneumococcal Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Serogroup
MH  - Streptococcus pneumoniae/*immunology
MH  - Vaccination
MH  - Vaccines, Conjugate/administration & dosage/adverse effects/immunology
MH  - Young Adult
OTO - NOTNLM
OT  - Immunogenicity
OT  - Pneumococcal conjugate vaccine
OT  - Safety
EDAT- 2015/04/29 06:00
MHDA- 2016/04/20 06:00
CRDT- 2015/04/28 06:00
PHST- 2014/11/25 00:00 [received]
PHST- 2015/04/08 00:00 [revised]
PHST- 2015/04/10 00:00 [accepted]
PHST- 2015/04/28 06:00 [entrez]
PHST- 2015/04/29 06:00 [pubmed]
PHST- 2016/04/20 06:00 [medline]
AID - S0264-410X(15)00478-8 [pii]
AID - 10.1016/j.vaccine.2015.04.025 [doi]
PST - ppublish
SO  - Vaccine. 2015 Jun 4;33(24):2793-9. doi: 10.1016/j.vaccine.2015.04.025. Epub 2015 
      Apr 23.