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

V920-012 Study Teama

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Abstract

Background. This study (NCT02503202) evaluated the safety of recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-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 rVSVΔG- ZEBOV-GP (2 × 10 7 plaque-forming units [pfu], n = 797; combined-lots group), a single high-dose lot of rVSVΔG-ZEBOV-GP (1 × 10 8 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°C) was observed in 20.2% of combined lots (3.2% with ≥39.0°C), 32.2% of high-dose (4.3% with ≥39.0°C), and 0.8% of placebo (0.8% with ≥39.0°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. rVSV' "G-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 rVSV' "G-ZEBOV-GP vaccine in persons at risk for Ebola virus disease. Clinical Trials Registration. NCT02503202.

Original languageEnglish (US)
Pages (from-to)1789-1798
Number of pages10
JournalJournal of Infectious Diseases
Volume215
Issue number12
DOIs
StatePublished - Jun 15 2017

Fingerprint

Ebolavirus
Vesicular Stomatitis
Vaccines
Placebos
Viruses
Safety
Arthralgia
Exanthema
Ebola Hemorrhagic Fever
Injections
Blister
Arthritis
Ebola virus envelope glycoprotein
Fever
Joints
Research Personnel
Clinical Trials
Temperature
Incidence

Keywords

  • Ebola
  • rVSVΔG-ZEBOV-GP
  • safety.
  • vaccine

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

Cite this

@article{8ea773ef304e41f6bb813a51caec17f3,
title = "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",
abstract = "Background. This study (NCT02503202) evaluated the safety of recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-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 rVSVΔG- ZEBOV-GP (2 × 10 7 plaque-forming units [pfu], n = 797; combined-lots group), a single high-dose lot of rVSVΔG-ZEBOV-GP (1 × 10 8 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°C) was observed in 20.2{\%} of combined lots (3.2{\%} with ≥39.0°C), 32.2{\%} of high-dose (4.3{\%} with ≥39.0°C), and 0.8{\%} of placebo (0.8{\%} with ≥39.0°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. rVSV' {"}G-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 rVSV' {"}G-ZEBOV-GP vaccine in persons at risk for Ebola virus disease. Clinical Trials Registration. NCT02503202.",
keywords = "Ebola, rVSVΔG-ZEBOV-GP, safety., vaccine",
author = "{V920-012 Study Teama} and Halperin, {Scott A.} and Arribas, {Jose R.} and Richard Rupp and Andrews, {Charles P.} and Laurence Chu and Rituparna Das and Simon, {Jakub K.} and Onorato, {Matthew T.} and Kenneth Liu and Jason Martin and Helmond, {Frans A.}",
year = "2017",
month = "6",
day = "15",
doi = "10.1093/infdis/jix189",
language = "English (US)",
volume = "215",
pages = "1789--1798",
journal = "Journal of Infectious Diseases",
issn = "0022-1899",
publisher = "Oxford University Press",
number = "12",

}

TY - JOUR

T1 - 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

AU - V920-012 Study Teama

AU - Halperin, Scott A.

AU - Arribas, Jose R.

AU - Rupp, Richard

AU - Andrews, Charles P.

AU - Chu, Laurence

AU - Das, Rituparna

AU - Simon, Jakub K.

AU - Onorato, Matthew T.

AU - Liu, Kenneth

AU - Martin, Jason

AU - Helmond, Frans A.

PY - 2017/6/15

Y1 - 2017/6/15

N2 - Background. This study (NCT02503202) evaluated the safety of recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-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 rVSVΔG- ZEBOV-GP (2 × 10 7 plaque-forming units [pfu], n = 797; combined-lots group), a single high-dose lot of rVSVΔG-ZEBOV-GP (1 × 10 8 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°C) was observed in 20.2% of combined lots (3.2% with ≥39.0°C), 32.2% of high-dose (4.3% with ≥39.0°C), and 0.8% of placebo (0.8% with ≥39.0°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. rVSV' "G-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 rVSV' "G-ZEBOV-GP vaccine in persons at risk for Ebola virus disease. Clinical Trials Registration. NCT02503202.

AB - Background. This study (NCT02503202) evaluated the safety of recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-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 rVSVΔG- ZEBOV-GP (2 × 10 7 plaque-forming units [pfu], n = 797; combined-lots group), a single high-dose lot of rVSVΔG-ZEBOV-GP (1 × 10 8 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°C) was observed in 20.2% of combined lots (3.2% with ≥39.0°C), 32.2% of high-dose (4.3% with ≥39.0°C), and 0.8% of placebo (0.8% with ≥39.0°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. rVSV' "G-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 rVSV' "G-ZEBOV-GP vaccine in persons at risk for Ebola virus disease. Clinical Trials Registration. NCT02503202.

KW - Ebola

KW - rVSVΔG-ZEBOV-GP

KW - safety.

KW - vaccine

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U2 - 10.1093/infdis/jix189

DO - 10.1093/infdis/jix189

M3 - Article

C2 - 28549145

AN - SCOPUS:85022326921

VL - 215

SP - 1789

EP - 1798

JO - Journal of Infectious Diseases

JF - Journal of Infectious Diseases

SN - 0022-1899

IS - 12

ER -