Safety and immunogenicity of an mRNA-lipid nanoparticle vaccine candidate against SARS-CoV-2 : A phase 1 randomized clinical trial.
Wien Klin Wochenschr
; 133(17-18): 931-941, 2021 Sep.
Article
em En
| MEDLINE
| ID: mdl-34378087
ABSTRACT
BACKGROUND:
We used the RNActive® technology platform (CureVac N.V., Tübingen, Germany) to prepare CVnCoV, a COVID-19 vaccine containing sequence-optimized mRNA coding for a stabilized form of SARS-CoV2 spike (S) protein encapsulated in lipid nanoparticles (LNP).METHODS:
This is an interim analysis of a dosage escalation phase 1 study in healthy 18-60-year-old volunteers in Hannover, Munich and Tübingen, Germany, and Ghent, Belgium. After giving 2 intramuscular doses of CVnCoV or placebo 28 days apart we assessed solicited local and systemic adverse events (AE) for 7 days and unsolicited AEs for 28 days after each vaccination. Immunogenicity was measured as enzyme-linked immunosorbent assay (ELISA) IgG antibodies to SARS-CoV2 Sprotein and receptor binding domain (RBD), and SARS-CoV2 neutralizing titers (MN50).RESULTS:
In 245 volunteers who received 2 CVnCoV vaccinations (2⯵g, nâ¯= 47, 4⯵g, nâ¯= 48, 6⯵g, nâ¯= 46, 8⯵g, nâ¯= 44, 12⯵g, nâ¯= 28) or placebo (nâ¯= 32) there were no vaccine-related serious AEs. Dosage-dependent increases in frequency and severity of solicited systemic AEs, and to a lesser extent local AEs, were mainly mild or moderate and transient in duration. Dosage-dependent increases in IgG antibodies to Sprotein and RBD and MN50 were evident in all groups 2 weeks after the second dose when 100% (23/23) seroconverted to Sprotein or RBD, and 83% (19/23) seroconverted for MN50 in the 12⯵g group. Responses to 12⯵g were comparable to those observed in convalescent sera from known COVID-19 patients.CONCLUSION:
In this study 2 CVnCoV doses were safe, with acceptable reactogenicity and 12⯵g dosages elicited levels of immune responses that overlapped those observed in convalescent sera.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vacinas
/
Nanopartículas
/
COVID-19
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
/
Adult
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Humans
/
Middle aged
Idioma:
En
Revista:
Wien Klin Wochenschr
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Alemanha