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

EBioMedicine

Antonios Aliprantis¹  Xin Cao¹  S. Aubrey Stoch¹  Mac McGuire¹  Roland Tschismarov¹  Jeffrey R. Sachs¹  Richard T. Wiedmann¹  Jonathan Hartzel¹  Katrin Ramsauer²  Deborah D. Brown³  Wen Liu⁴  Yvonne Tomberger⁴  Kevin Russell⁴  Weifeng Xu⁴  Keith Boundy⁴  Jianing Li⁴  Liesbeth Haspeslagh⁴  Michelle Davila⁴  Eseng Lai⁴  Frédéric Vanhoutte⁵ 

[1] Co., Inc., Kenilworth, NJ, USA;Currently at AlloVir, Inc., Cambridge, MA, USA;Currently at Flagship Pioneering, Boston, MA, USA;;Merck &SGS Life Sciences, Antwerp, Belgium;

关键词: COVID-19;    SARS-CoV-2;    Vaccine;   

DOI  :  

来源: DOAJ

【 摘 要 】

Summary: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 (4:1 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.

【 授权许可】

Unknown