PMID- 27149114
OWN - NLM
STAT- MEDLINE
DCOM- 20171019
LR  - 20181113
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 12
IP  - 8
DP  - 2016 Aug 2
TI  - Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide 
      vaccine in Russian subjects.
PG  - 2142-2147
AB  - Pneumococcal infection is a major cause of pneumonia, bacteremia, and meningitis. 
      Incidence of pneumococcal disease (PD) varies worldwide. The 23-valent 
      pneumococcal polysaccharide vaccine (PPV23) displays an acceptable safety profile 
      and has been demonstrated cost-effective in reducing burden of PD. METHODS: 
      Approximately 100 subjects from the Russian Federation who were either 2 to 49 y 
      of age with increased risk for PD or >/=50 years of age were enrolled into the 
      study (NCT01734239) to receive a single dose of PPV23 administered 
      intramuscularly. Each subject was followed for local and systemic adverse events 
      (AEs) for 5 and 14 days, respectively. Serious AEs were collected for 28 d 
      postvaccination. Blood samples were collected immediately prior to vaccination 
      and 28 d postvaccination for the measurement of IgG to serotypes 1, 6B, 14, 19F, 
      and 23F. RESULTS: High proportion of subjects had >/=2 -fold increase in IgG 
      following receipt of PPV23. Rates were 92.0%, 83.0%, 89.0%, 81%, 84% for 
      serotypes 1, 6B, 14, 19F, and 23F, respectively. Similar rates of responders and 
      increases in the magnitude of immune responses were observed in both age groups 
      (2-49, >/=50 ). PPV23 was generally safe and well tolerated. Injection site and 
      systemic AEs were reported by 14.7% and 18.6% of study subjects, respectively. 
      CONCLUSIONS: PPV23 is generally safe, well tolerated, and highly immunogenic when 
      given as a single dose to Russian individuals 50 y of age and older, as well as 
      Russian individuals 2 to 49 y of age who are at high risk for PD.
FAU - Ciprero, Karen
AU  - Ciprero K
AD  - a Merck & Co., Inc. , Kenilworth , NJ , USA.
FAU - Zykov, Kirill A
AU  - Zykov KA
AD  - b Moscow State University of Medicine and Dentistry , Moscow , Russian 
      Federation.
FAU - Briko, Nikolay I
AU  - Briko NI
AD  - c I.M. Sechenov First Moscow State Medical University , Moscow , Russian 
      Federation.
FAU - Shekar, Tulin
AU  - Shekar T
AD  - a Merck & Co., Inc. , Kenilworth , NJ , USA.
FAU - Sterling, Tina M
AU  - Sterling TM
AD  - a Merck & Co., Inc. , Kenilworth , NJ , USA.
FAU - Bitieva, Elizaveta
AU  - Bitieva E
AD  - d Merck Sharp & Dohme (MSD) Pharmaceuticals LLC , Moscow , Russian Federation.
FAU - Stek, Jon E
AU  - Stek JE
AD  - a Merck & Co., Inc. , Kenilworth , NJ , USA.
FAU - Musey, Luwy
AU  - Musey L
AD  - a Merck & Co., Inc. , Kenilworth , NJ , USA.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20160505
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (23-valent pneumococcal capsular polysaccharide vaccine)
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Pneumococcal Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Bacterial/*blood
MH  - Child
MH  - Child, Preschool
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Female
MH  - Humans
MH  - Immunoglobulin G/blood
MH  - Injections, Intramuscular
MH  - Male
MH  - Middle Aged
MH  - Pneumococcal Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Russia
MH  - Young Adult
PMC - PMC4994758
OTO - NOTNLM
OT  - Russian population
OT  - immunogenicity
OT  - pneumococcal polysaccharide vaccine
OT  - pneumococcal vaccine
OT  - safety
EDAT- 2016/05/06 06:00
MHDA- 2017/10/20 06:00
PMCR- 2017/05/05
CRDT- 2016/05/06 06:00
PHST- 2016/05/06 06:00 [pubmed]
PHST- 2017/10/20 06:00 [medline]
PHST- 2016/05/06 06:00 [entrez]
PHST- 2017/05/05 00:00 [pmc-release]
AID - 1165373 [pii]
AID - 10.1080/21645515.2016.1165373 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2016 Aug 2;12(8):2142-2147. doi: 
      10.1080/21645515.2016.1165373. Epub 2016 May 5.