PMID- 26928074
OWN - NLM
STAT- MEDLINE
DCOM- 20161007
LR  - 20220318
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 34
IP  - 15
DP  - 2016 Apr 4
TI  - A randomized, observer-blind Phase Ib study to identify formulations and vaccine 
      schedules of a trivalent Group B Streptococcus vaccine for use in non-pregnant 
      and pregnant women.
PG  - 1786-91
LID - S0264-410X(16)00215-2 [pii]
LID - 10.1016/j.vaccine.2016.02.044 [doi]
AB  - BACKGROUND: Group B streptococcus (GBS) is a leading cause of sepsis and 
      meningitis in early infancy. Substantial data demonstrate that women with higher 
      levels of circulating antibody against the capsular polysaccharide (CPS) deliver 
      infants at reduced risk of GBS infection, which serves as the basis for vaccine 
      design. This study evaluates two different dosages, two injection schedules and 
      three formulations of an investigational trivalent (serotypes Ia, Ib and III) 
      CRM197-glycoconjugate GBS vaccine in healthy, non-pregnant women. METHODS: 678 
      healthy non-pregnant women received one or two injections of one of two dosages 
      (5/5/5 mug or 20/20/20 mug) of the investigational vaccine, formulated with or 
      without aluminum hydroxide (Enrollment Group 1), or with full or half dosages of 
      MF59((R)) (Enrollment Group 2); or a placebo (Enrollment Groups 1 and 2). Geometric 
      mean serotype-specific antibody concentrations (GMCs) at Days 61 (Enrollment 
      Group 1) and 361 (both Groups) were analyzed to select a formulation suitable for 
      pregnant or non-pregnant women, respectively. Solicited adverse reactions were 
      recorded up to Day 7 and adverse events (AEs) were recorded throughout the study. 
      RESULTS: Rates of reported AEs were similar across all groups. Higher rates of 
      local reactogenicity were seen in adjuvanted vaccine groups compared with 
      non-adjuvanted vaccine (or placebo) groups. All vaccine groups elicited higher 
      GMCs than placebo; differences between treatments were not statistically 
      significant, indicating no additional potential benefit of higher antigen 
      content, addition of adjuvant, or a second dose. CONCLUSIONS: All GBS vaccine 
      formulations induced a persistent antibody response and showed similar 
      immunogenicity profiles (NCT01150123).
CI  - Copyright (c) 2016 Elsevier Ltd. All rights reserved.
FAU - Leroux-Roels, Geert
AU  - Leroux-Roels G
AD  - Centre for Vaccinology, Ghent University Hospital, Ghent, Belgium.
FAU - Maes, Cathy
AU  - Maes C
AD  - Centre for Vaccinology, Ghent University Hospital, Ghent, Belgium.
FAU - Willekens, Julie
AU  - Willekens J
AD  - Centre for Vaccinology, Ghent University Hospital, Ghent, Belgium.
FAU - De Boever, Fien
AU  - De Boever F
AD  - Centre for Vaccinology, Ghent University Hospital, Ghent, Belgium.
FAU - de Rooij, Richard
AU  - de Rooij R
AD  - GlaxoSmithKline BV, Amsterdam, The Netherlands.
FAU - Martell, Leah
AU  - Martell L
AD  - GlaxoSmithKline LLC, Cambridge, MA, USA.
FAU - Bedell, Lisa
AU  - Bedell L
AD  - GlaxoSmithKline LLC, Cambridge, MA, USA. Electronic address: 
      lisa.x.bedell@gsk.com.
FAU - Wittke, Frederick
AU  - Wittke F
AD  - GSK Vaccines S.r.l, Siena, Italy.
FAU - Slobod, Karen
AU  - Slobod K
AD  - GlaxoSmithKline LLC, Cambridge, MA, USA.
FAU - Dull, Peter
AU  - Dull P
AD  - GlaxoSmithKline LLC, Cambridge, MA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01150123
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20160305
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Polysaccharides, Bacterial)
RN  - 0 (Streptococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Adjuvants, Immunologic/administration & dosage
MH  - Adult
MH  - Antibodies, Bacterial/blood
MH  - Female
MH  - Humans
MH  - Immunity, Humoral
MH  - *Immunization Schedule
MH  - Polysaccharides, Bacterial/immunology
MH  - Pregnancy
MH  - Single-Blind Method
MH  - Streptococcal Infections/*prevention & control
MH  - Streptococcal Vaccines/*administration & dosage/adverse effects/therapeutic use
MH  - Streptococcus agalactiae
MH  - Vaccines, Conjugate/administration & dosage/adverse effects/therapeutic use
MH  - Young Adult
OTO - NOTNLM
OT  - Adjuvant
OT  - Group B streptococcus
OT  - Trivalent vaccine
EDAT- 2016/03/02 06:00
MHDA- 2016/10/08 06:00
CRDT- 2016/03/02 06:00
PHST- 2015/11/25 00:00 [received]
PHST- 2016/02/12 00:00 [revised]
PHST- 2016/02/16 00:00 [accepted]
PHST- 2016/03/02 06:00 [entrez]
PHST- 2016/03/02 06:00 [pubmed]
PHST- 2016/10/08 06:00 [medline]
AID - S0264-410X(16)00215-2 [pii]
AID - 10.1016/j.vaccine.2016.02.044 [doi]
PST - ppublish
SO  - Vaccine. 2016 Apr 4;34(15):1786-91. doi: 10.1016/j.vaccine.2016.02.044. Epub 2016 
      Mar 5.