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Safety and immunogenicity of the measles vector-based SARS-CoV-2 vaccine candidate, V591, in adults: results from a phase 1/2 randomised, double-blind, placebo-controlled, dose-ranging trial.
Vanhoutte, Frédéric; Liu, Wen; Wiedmann, Richard T; Haspeslagh, Liesbeth; Cao, Xin; Boundy, Keith; Aliprantis, Antonios; Davila, Michelle; Hartzel, Jonathan; Li, Jianing; McGuire, Mac; Ramsauer, Katrin; Tomberger, Yvonne; Tschismarov, Roland; Brown, Deborah D; Xu, Weifeng; Sachs, Jeffrey R; Russell, Kevin; Stoch, S Aubrey; Lai, Eseng.
  • Vanhoutte F; SGS Life Sciences, Antwerp, Belgium.
  • Liu W; Merck & Co., Inc., Kenilworth, NJ, USA.
  • Wiedmann RT; Merck & Co., Inc., Kenilworth, NJ, USA.
  • Haspeslagh L; Merck & Co., Inc., Kenilworth, NJ, USA.
  • Cao X; Merck & Co., Inc., Kenilworth, NJ, USA.
  • Boundy K; Merck & Co., Inc., Kenilworth, NJ, USA; Currently at AlloVir, Inc., Cambridge, MA, USA.
  • Aliprantis A; Merck & Co., Inc., Kenilworth, NJ, USA; Currently at Flagship Pioneering, Boston, MA, USA.
  • Davila M; Merck & Co., Inc., Kenilworth, NJ, USA.
  • Hartzel J; Merck & Co., Inc., Kenilworth, NJ, USA.
  • Li J; Merck & Co., Inc., Kenilworth, NJ, USA.
  • McGuire M; Merck & Co., Inc., Kenilworth, NJ, USA.
  • Ramsauer K; Themis Bioscience GmbH, Vienna, Austria, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
  • Tomberger Y; Themis Bioscience GmbH, Vienna, Austria, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
  • Tschismarov R; Themis Bioscience GmbH, Vienna, Austria, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
  • Brown DD; Merck & Co., Inc., Kenilworth, NJ, USA.
  • Xu W; Merck & Co., Inc., Kenilworth, NJ, USA.
  • Sachs JR; Merck & Co., Inc., Kenilworth, NJ, USA.
  • Russell K; Merck & Co., Inc., Kenilworth, NJ, USA.
  • Stoch SA; Merck & Co., Inc., Kenilworth, NJ, USA.
  • Lai E; Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: eseng_lai@merck.com.
EBioMedicine ; 75: 103811, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1638699
ABSTRACT

BACKGROUND:

We report on the safety and immunogenicity of V591, a measles vector-based SARS-CoV-2 vaccine candidate.

METHODS:

In this multicentre, randomised, placebo-controlled, double-blind, phase 1/2 trial, healthy adults with no history of COVID-19 disease were assigned to intramuscular injection of V591 or placebo (41 ratio). In part 1, younger adults (18-55 years) received V591 median tissue culture infectious dose (TCID50)-levels of 1×105 or 1×106 or placebo, 56 days apart. In part 2, younger and older (>55 years) adults received a single dose of one of four (104/105/106/107) or one of two (105/106) V591 TCID50 levels, respectively, or placebo. PRIMARY

OUTCOME:

safety/tolerability. Secondary

outcome:

humoral immunogenicity. ClinicalTrials.gov NCT04498247.

FINDINGS:

From August-December 2020, 444 participants were screened and 263 randomised (210 V591; 53 placebo); 262 received at least one and 10 received two doses of V591 or placebo. Adverse events were experienced by 140/209 (67.0%) V591 dose-group participants and 37/53 (69.8%) placebo-group participants following injection 1; most frequent were fatigue (57 [27.3%] vs 20 [37.7%]), headache (57 [27.3%] vs 19 [35.8%]), myalgia (35 [16.7%] vs 10 [18.9%]), and injection-site pain (35 [16.7%] vs 4 [7.5%]). No deaths nor vaccine-related serious adverse events occurred. At Day 29, no anti-SARS-CoV-2 spike serum neutralising antibody and IgG-responses were identified in placebo or the three lower V591 dose-groups; responses were detected with V591 1×107 TCID50, although titres were lower than convalescent serum.

INTERPRETATION:

V591 was generally well tolerated, but immunogenicity was insufficient to warrant continued development.

FUNDING:

Merck Sharp & Dohme, Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunogenicity, Vaccine / COVID-19 Vaccines / Genetic Vectors / SARS-CoV-2 / COVID-19 / Measles virus Type of study: Controlled clinical trial / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adolescent / Adult / Female / Humans / Male / Middle aged Language: English Journal: EBioMedicine Year: 2022 Document Type: Article Affiliation country: J.ebiom.2021.103811

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunogenicity, Vaccine / COVID-19 Vaccines / Genetic Vectors / SARS-CoV-2 / COVID-19 / Measles virus Type of study: Controlled clinical trial / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adolescent / Adult / Female / Humans / Male / Middle aged Language: English Journal: EBioMedicine Year: 2022 Document Type: Article Affiliation country: J.ebiom.2021.103811