Safety and immunogenicity of intramuscular, single-dose V590 (rVSV-SARS-CoV-2 Vaccine) in healthy adults: Results from a phase 1 randomised, double-blind, placebo-controlled, dose-ranging trial.
COVID-19
SARS-CoV-2
V590
Vaccine
Vesicular stomatitis virus (VSV)
Journal
EBioMedicine
ISSN: 2352-3964
Titre abrégé: EBioMedicine
Pays: Netherlands
ID NLM: 101647039
Informations de publication
Date de publication:
Aug 2022
Aug 2022
Historique:
received:
09
07
2021
revised:
01
06
2022
accepted:
17
06
2022
pubmed:
10
7
2022
medline:
17
8
2022
entrez:
9
7
2022
Statut:
ppublish
Résumé
Vaccines against COVID-19 are needed to overcome challenges associated with mitigating the global pandemic. We report the safety and immunogenicity of V590, a live recombinant vesicular stomatitis virus-based COVID-19 vaccine candidate. In this placebo-controlled, double-blind, three-part phase 1 study, healthy adults were randomised to receive a single intramuscular dose of vaccine or placebo. In Part 1, younger (18-54 years) and, in Part 2, older (≥55 years) adults seronegative for SARS-CoV-2 nucleocapsid received one of four V590 dose levels (5.00 × 10 232 participants were randomised and 219 completed the study. In seronegative participants, anti-SARS-CoV-2 spike-specific antibody responses to V590 were low and comparable to placebo across the lower dose levels. At the highest dose level (5.55 × 10 V590 was generally well-tolerated. However, Day 28 anti-SARS-Cov-2 spike-specific antibody responses in seronegative participants following a single intramuscular administration of V590 were not sufficient to warrant continued development. The study was funded by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Sections du résumé
BACKGROUND
BACKGROUND
Vaccines against COVID-19 are needed to overcome challenges associated with mitigating the global pandemic. We report the safety and immunogenicity of V590, a live recombinant vesicular stomatitis virus-based COVID-19 vaccine candidate.
METHODS
METHODS
In this placebo-controlled, double-blind, three-part phase 1 study, healthy adults were randomised to receive a single intramuscular dose of vaccine or placebo. In Part 1, younger (18-54 years) and, in Part 2, older (≥55 years) adults seronegative for SARS-CoV-2 nucleocapsid received one of four V590 dose levels (5.00 × 10
FINDINGS
RESULTS
232 participants were randomised and 219 completed the study. In seronegative participants, anti-SARS-CoV-2 spike-specific antibody responses to V590 were low and comparable to placebo across the lower dose levels. At the highest dose level (5.55 × 10
INTERPRETATION
CONCLUSIONS
V590 was generally well-tolerated. However, Day 28 anti-SARS-Cov-2 spike-specific antibody responses in seronegative participants following a single intramuscular administration of V590 were not sufficient to warrant continued development.
FUNDING
BACKGROUND
The study was funded by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Identifiants
pubmed: 35809371
pii: S2352-3964(22)00319-X
doi: 10.1016/j.ebiom.2022.104138
pmc: PMC9259069
pii:
doi:
Substances chimiques
Antibodies, Viral
0
COVID-19 Vaccines
0
Vaccines
0
Banques de données
ClinicalTrials.gov
['NCT04569786']
Types de publication
Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
104138Informations de copyright
Copyright © 2022 Merck Sharp & Dohme Corp., a subsidiary Merck & Co., Inc., The Author(s). Published by Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of interests JAR, QH, SD, TC, JC, JL, JS, CH, XZ, RW, EL, PA, DG and SAS are employees of Merck Sharpe & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and may own stock or hold stock options in Merck & Co., Inc., Rahway, NJ, USA. JRS is an employee of Merck Sharpe & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA holding stocks alongside stocks in various pharmaceutical and biotechnology companies and service providers, has participated on various editorial boards and committees for Society for Industrial and Applied Mathematics and is a member and participant in committees for the International Society of Pharmacometrics. All other authors report no conflicts of interest.