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
; 75: 103811, 2022 Jan.
Article
em En
| MEDLINE
| ID: mdl-35042081
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. PRIMARYOUTCOME:
safety/tolerability. Secondaryoutcome:
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Imunogenicidade da Vacina
/
Vacinas contra COVID-19
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Vetores Genéticos
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SARS-CoV-2
/
COVID-19
/
Vírus do Sarampo
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Adolescent
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Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
EBioMedicine
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Bélgica