Safety and immunogenicity of a recombinant receptor-binding domain-based protein subunit vaccine (Noora vaccine™) against COVID-19 in adults: A randomized, double-blind, placebo-controlled, Phase 1 trial.
COVID-19
Noora vaccine
SARS-CoV-2
immunogenicity
protein subunit
safety
Journal
Journal of medical virology
ISSN: 1096-9071
Titre abrégé: J Med Virol
Pays: United States
ID NLM: 7705876
Informations de publication
Date de publication:
Feb 2023
Feb 2023
Historique:
revised:
01
08
2022
received:
17
06
2022
accepted:
25
08
2022
pubmed:
28
8
2022
medline:
3
3
2023
entrez:
27
8
2022
Statut:
ppublish
Résumé
The development of a safe and effective vaccine is essential to protect populations against coronavirus disease 2019 (COVID-19). There are several vaccine candidates under investigation with different mechanisms of action. In the present study, we have evaluated the safety and immunogenicity of a recombinant receptor-binding domain (RBD)-based protein subunit vaccine (Noora vaccine) against COVID-19 in adults. This Phase 1 trial is a randomized, double-blind, placebo-controlled study to evaluate the safety and immunogenicity of the recombinant RBD-based protein subunit vaccine (Noora vaccine) against COVID-19 in healthy adults volunteers. Eligible participants were included in this study after evaluating their health status and considering the exclusion criteria. They were then randomized into three groups and received three doses of vaccine (80 µg, 120 µg, and placebo) on Days 0, 21, and 35. Primary outcomes including solicited, unsolicited, and medically attended adverse events were recorded during this study. Secondary outcomes including the humoral and cellular immunity (including anti-RBD IgG antibody and neutralizing antibody) were measured on Days 0, 21, 28, 35, 42, and 49 by using the ELISA kit and the Virus Neutralization Test (VNT) was performed on day 49. Totally 70 cases were included in this Phase 1 trial and 60 of them completed the study. Safety assessments showed no severe adverse events. Local pain at the vaccine injection site occurred in 80% of the vaccinated volunteers. Induration and redness at the injection site were the other adverse reactions of this vaccine. There was no significant difference between the studied groups regarding adverse reactions. Anti-RBD IgG antibody and neutralizing antibody assessment showed significant seroconversion in comparison to the placebo group (80%, and 100% respectively, p < 0.001). The cellular immunity panel also showed mild to moderate induction of TH1 responses and the VNT showed 78% of seroprotection. The results of this Phase 1 trial showed acceptable safety without serious adverse events and significant seroconversions in the humoral and cellular immunity panel. The dose of 80 µg is an appropriate dose for injection in the next phases of the trial.
Identifiants
pubmed: 36029105
doi: 10.1002/jmv.28097
pmc: PMC9539327
doi:
Substances chimiques
Protein Subunits
0
Antibodies, Neutralizing
0
Vaccines, Synthetic
0
Vaccines, Subunit
0
Immunoglobulin G
0
Antibodies, Viral
0
Types de publication
Randomized Controlled Trial
Clinical Trial, Phase I
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Baqiyatallah University of Medical Science
ID : 5121
Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2022 Wiley Periodicals LLC.
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