Post by Nadica (She/Her) on Nov 7, 2024 4:24:22 GMT
Safety and pharmacodynamics of intranasal administration of recombinant human interferon alfa-2b as a potential prophylactic for SARS-CoV-2 infection in an at-risk group: a phase I-II clinical trial, open, uncontrolled, in a single-arm (OLIVO Study) - Preprint Posted Nov 6, 2024
Abstract
Type I interferons (IFN α and β) represent a promising potential candidate for the development of a broad-spectrum antiviral therapy in the event of a global viral outbreak. This study aimed to investigate the safety of intranasal administration of recombinant human interferon alpha 2b (Nasalferon) in order to characterize adverse events and to determine the gene expression levels of the pharmacodynamic response marker, 2’,5’-oligoadenylate synthetase 1 (OAS1), in oropharyngeal swabs and peripheral blood. A Phase I-II, open-label, uncontrolled, single-group clinical trial was conducted. The study enrolled 80 subjects over the age of 19 years who were healthcare workers and who provided written informed consent to participate. The product was administered intranasally, twice daily for 10 days at a daily concentration of 2 million international units (MIU). The clinical trial was registered in the Cuban Public Registry of Clinical Trials (RPCEC00000337). The intranasal administration of Nasalferon was found to be safe and well tolerated, with no serious adverse events reported. The incidence of adverse events was 45/80 (56.3%). Nasalferon administration activated the transcript for OAS1 in 97.5% of subjects, with an increase in OAS1 expression in the oropharynx from 24 to 120 hours. The product also activated OAS1 expression in peripheral blood mononuclear cells (PBMC) in 50% of subjects at 120 hours. Intranasal administration of Nasalferon was safe, well tolerated, and activated the transcript for OAS1 in subjects at the time of the study.
Abstract
Type I interferons (IFN α and β) represent a promising potential candidate for the development of a broad-spectrum antiviral therapy in the event of a global viral outbreak. This study aimed to investigate the safety of intranasal administration of recombinant human interferon alpha 2b (Nasalferon) in order to characterize adverse events and to determine the gene expression levels of the pharmacodynamic response marker, 2’,5’-oligoadenylate synthetase 1 (OAS1), in oropharyngeal swabs and peripheral blood. A Phase I-II, open-label, uncontrolled, single-group clinical trial was conducted. The study enrolled 80 subjects over the age of 19 years who were healthcare workers and who provided written informed consent to participate. The product was administered intranasally, twice daily for 10 days at a daily concentration of 2 million international units (MIU). The clinical trial was registered in the Cuban Public Registry of Clinical Trials (RPCEC00000337). The intranasal administration of Nasalferon was found to be safe and well tolerated, with no serious adverse events reported. The incidence of adverse events was 45/80 (56.3%). Nasalferon administration activated the transcript for OAS1 in 97.5% of subjects, with an increase in OAS1 expression in the oropharynx from 24 to 120 hours. The product also activated OAS1 expression in peripheral blood mononuclear cells (PBMC) in 50% of subjects at 120 hours. Intranasal administration of Nasalferon was safe, well tolerated, and activated the transcript for OAS1 in subjects at the time of the study.