PMID- 28549145
OWN - NLM
STAT- MEDLINE
DCOM- 20170907
LR  - 20181218
IS  - 1537-6613 (Electronic)
IS  - 0022-1899 (Print)
IS  - 0022-1899 (Linking)
VI  - 215
IP  - 12
DP  - 2017 Jun 15
TI  - Six-Month Safety Data of Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus 
      Envelope Glycoprotein Vaccine in a Phase 3 Double-Blind, Placebo-Controlled 
      Randomized Study in Healthy Adults.
PG  - 1789-1798
LID - 10.1093/infdis/jix189 [doi]
AB  - BACKGROUND: This study (NCT02503202) evaluated the safety of recombinant 
      vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine 
      (rVSVDeltaG-ZEBOV-GP). METHODS: Overall, 1197 subjects were randomized 2:2:2:2:1; 
      1194 were vaccinated with 1 dose of 1 of 3 lots of rVSVDeltaG- ZEBOV-GP (2 x 107 
      plaque-forming units [pfu], n = 797; combined-lots group), a single high-dose lot 
      of rVSVDeltaG-ZEBOV-GP (1 x 108 pfu, n = 264; high-dose group), or placebo (n = 133). 
      Daily temperatures and adverse events (AEs) were recorded days 1 to 42 
      postvaccination. Solicited AEs included injection-site AEs from days 1 to 5, and 
      joint pain, joint swelling, vesicular lesions (blisters), and rashes from days 1 
      to 42. Serious AEs (SAEs) were recorded through 6 months postvaccination. 
      RESULTS: Fever (>/=38.0 degrees C) was observed in 20.2% of combined lots (3.2% with 
      >/=39.0 degrees C), 32.2% of high-dose (4.3% with >/=39.0 degrees C), and 0.8% of placebo (0.8% with 
      >/=39.0 degrees C). Incidences of AEs of interest (days 1-42) were arthralgia (17.1% 
      combined lots, 20.4% high-dose, 3.0% placebo), arthritis (5.1% combined lots, 
      4.2% high-dose, 0.0% placebo), and rash (3.8% combined lots, 3.8% high-dose, 1.5% 
      placebo). Twenty-one SAEs and 2 deaths were reported, all assessed by 
      investigators as unrelated to vaccine. CONCLUSIONS: rVSVDeltaG-ZEBOV-GP was generally 
      well-tolerated, with increased rates of injection-site and systemic AEs compared 
      to placebo, and no vaccine-related SAEs or deaths. These findings support the use 
      of rVSVDeltaG-ZEBOV-GP vaccine in persons at risk for Ebola virus disease. CLINICAL 
      TRIALS REGISTRATION: NCT02503202.
CI  - (c) The Author 2017. Published by Oxford University Press for the Infectious 
      Diseases Society of America. All rights reserved. For permissions, e-mail: 
      journals.permissions@oup.com.
FAU - Halperin, Scott A
AU  - Halperin SA
AD  - Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, and 
      Nova Scotia Health Authority, Halifax, Canada.
FAU - Arribas, Jose R
AU  - Arribas JR
AD  - Hospital Universitario La Paz, IdiPAZ, Madrid, Spain.
FAU - Rupp, Richard
AU  - Rupp R
AD  - University of Texas Medical Branch at Galveston.
FAU - Andrews, Charles P
AU  - Andrews CP
AD  - Diagnostics Research Group, San Antonio.
FAU - Chu, Laurence
AU  - Chu L
AD  - Benchmark Research, Austin, Texas.
FAU - Das, Rituparna
AU  - Das R
AD  - Merck & Co, Inc, Kenilworth, New Jersey.
FAU - Simon, Jakub K
AU  - Simon JK
AD  - Merck & Co, Inc, Kenilworth, New Jersey.
FAU - Onorato, Matthew T
AU  - Onorato MT
AD  - Merck & Co, Inc, Kenilworth, New Jersey.
FAU - Liu, Kenneth
AU  - Liu K
AD  - Merck & Co, Inc, Kenilworth, New Jersey.
FAU - Martin, Jason
AU  - Martin J
AD  - Merck & Co, Inc, Kenilworth, New Jersey.
FAU - Helmond, Frans A
AU  - Helmond FA
AD  - Merck & Co, Inc, Kenilworth, New Jersey.
CN  - V920-012 Study Team
LA  - eng
SI  - ClinicalTrials.gov/NCT02503202
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Infect Dis
JT  - The Journal of infectious diseases
JID - 0413675
RN  - 0 (Ebola Vaccines)
RN  - 0 (Vaccines, Synthetic)
RN  - 0 (Viral Envelope Proteins)
RN  - 0 (envelope glycoprotein, Ebola virus)
SB  - IM
CIN - J Infect Dis. 2017 Jun 15;215(12):1775-1776. PMID: 28431160
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Double-Blind Method
MH  - Ebola Vaccines/*adverse effects/immunology
MH  - Ebolavirus/*immunology
MH  - Female
MH  - Healthy Volunteers/statistics & numerical data
MH  - Hemorrhagic Fever, Ebola/*prevention & control
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Vaccination/methods
MH  - Vaccines, Synthetic/adverse effects/immunology
MH  - Vesicular Stomatitis/*immunology
MH  - Viral Envelope Proteins/adverse effects/*immunology
MH  - Young Adult
PMC - PMC5853326
OTO - NOTNLM
OT  - Ebola
OT  - rVSVDeltaG-ZEBOV-GP
OT  - safety
OT  - vaccine
EDAT- 2017/05/27 06:00
MHDA- 2017/09/08 06:00
PMCR- 2018/06/15
CRDT- 2017/05/27 06:00
PHST- 2016/10/20 00:00 [received]
PHST- 2017/04/28 00:00 [accepted]
PHST- 2017/05/27 06:00 [pubmed]
PHST- 2017/09/08 06:00 [medline]
PHST- 2017/05/27 06:00 [entrez]
PHST- 2018/06/15 00:00 [pmc-release]
AID - 3855263 [pii]
AID - jix189 [pii]
AID - 10.1093/infdis/jix189 [doi]
PST - ppublish
SO  - J Infect Dis. 2017 Jun 15;215(12):1789-1798. doi: 10.1093/infdis/jix189.