PMID- 28068212
OWN - NLM
STAT- MEDLINE
DCOM- 20180207
LR  - 20181113
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 13
IP  - 5
DP  - 2017 May 4
TI  - Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate 
      vaccine in adults >/= 50 years of age with a prior history of herpes zoster: A 
      phase III, non-randomized, open-label clinical trial.
PG  - 1051-1058
LID - 10.1080/21645515.2016.1265715 [doi]
AB  - This phase III, non-randomized, open-label, multi-center study (NCT01827839) 
      evaluated the immunogenicity and safety of an adjuvanted recombinant subunit 
      herpes zoster (HZ) vaccine (HZ/su) in adults aged >/= 50 y with prior 
      physician-documented history of HZ. Participants (stratified by age: 50-59, 60-69 
      and >/= 70 y) received 2 doses of HZ/su 2 months apart and were followed-up for 
      another 12 months. Anti-glycoprotein E (gE) antibodies were measured by 
      enzyme-linked immunosorbent assay before vaccination and 1 month after the second 
      dose (Month 3). Solicited local and general adverse events (AEs) were recorded 
      for 7 d and unsolicited AEs for 30 d after each vaccination. Serious AEs were 
      recorded until study end. The primary immunogenicity objective was met if the 
      lower limit of the 95% confidence interval (CI) of the vaccine response rate 
      (VRR), defined as a 4-fold increase in anti-gE over baseline, at Month 3 was >/= 
      60%. 96 participants (32/age group) were enrolled. The primary immunogenicity 
      objective was met, as the VRR at Month 3 was 90.2% (95% CI: 81.7-95.7). Geometric 
      mean anti-gE antibody concentrations at Month 3 were similar across age groups. 
      77.9% and 71.6% of participants reported local and general solicited AEs, 
      respectively. The most frequent solicited AEs were pain at injection site, 
      fatigue, headache, myalgia and shivering. The HZ/su vaccine was immunogenic in 
      adults aged >/= 50 y with a physician-documented history of HZ, and no safety 
      concerns were identified.
FAU - Godeaux, Olivier
AU  - Godeaux O
AD  - a GSK Vaccines , Wavre , Belgium.
FAU - Kovac, Martina
AU  - Kovac M
AD  - a GSK Vaccines , Wavre , Belgium.
FAU - Shu, Daniel
AU  - Shu D
AD  - b Gain Medical Centre , Coquitlam , BC , Canada.
FAU - Grupping, Katrijn
AU  - Grupping K
AD  - a GSK Vaccines , Wavre , Belgium.
FAU - Campora, Laura
AU  - Campora L
AD  - a GSK Vaccines , Wavre , Belgium.
FAU - Douha, Martine
AU  - Douha M
AD  - a GSK Vaccines , Wavre , Belgium.
FAU - Heineman, Thomas C
AU  - Heineman TC
AD  - c GSK Vaccines , King of Prussia , PA , USA.
FAU - Lal, Himal
AU  - Lal H
AD  - c GSK Vaccines , King of Prussia , PA , USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01827839
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20170109
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Herpes Zoster Vaccine)
RN  - 0 (Vaccines, Subunit)
RN  - 0 (Viral Envelope Proteins)
RN  - 0 (glycoprotein E, varicella-zoster virus)
SB  - IM
MH  - *Adjuvants, Immunologic
MH  - Aged
MH  - Antibodies, Viral/*blood
MH  - Antibody Formation
MH  - CD4-Positive T-Lymphocytes/immunology
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Enzyme-Linked Immunosorbent Assay
MH  - Female
MH  - Herpes Zoster/immunology/*prevention & control
MH  - Herpes Zoster Vaccine/administration & dosage/*adverse effects/*immunology
MH  - Herpesvirus 3, Human/*immunology
MH  - Humans
MH  - *Immunogenicity, Vaccine
MH  - Male
MH  - Middle Aged
MH  - Vaccines, Subunit/immunology
MH  - Viral Envelope Proteins/immunology
PMC - PMC5443374
OTO - NOTNLM
OT  - herpes zoster
OT  - immunogenicity
OT  - safety
OT  - varicella-zoster virus
OT  - zoster vaccine
EDAT- 2017/01/10 06:00
MHDA- 2018/02/08 06:00
PMCR- 2017/01/09
CRDT- 2017/01/10 06:00
PHST- 2017/01/10 06:00 [pubmed]
PHST- 2018/02/08 06:00 [medline]
PHST- 2017/01/10 06:00 [entrez]
PHST- 2017/01/09 00:00 [pmc-release]
AID - 1265715 [pii]
AID - 10.1080/21645515.2016.1265715 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2017 May 4;13(5):1051-1058. doi: 
      10.1080/21645515.2016.1265715. Epub 2017 Jan 9.