• Assessment of safety and intranasal neutralizing antibodies of HPMC-based human anti-SARS-CoV-2 IgG1 nasal spray in healthy volunteers

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Metadata

Document Title

Assessment of safety and intranasal neutralizing antibodies of HPMC-based human anti-SARS-CoV-2 IgG1 nasal spray in healthy volunteers

Author

Imsuwansri T. Jongthitinon T. Pojdoung N. Meesiripan N. Sakarin S. Boonkrai C. Wongtangprasert T. Phakham T. Audomsun T. Attakitbancha C. Saelao P. Muanwien P. Tian M.T. Tongchusak S. Sangruji B. Wannigama D.L. Sawangmake C. Rodprasert W. Le Q.D. Purbantoro S.D. Vasuntrarak K. Nantavisai S. Sirilak S. Uppapong B. Sapsutthipas S. Trisiriwanich S. Somporn T. Usoo A. Mingngamsup N. Phumiamorn S. Aumklad P. Arunprasert K. Patrojanasophon P. Opanasopit P. Pesirikan N. Nitisaporn L. Pitchayakorn J. Narkthong T. Mahong B. Chaiyo K. Srisutthisamphan K. Viriyakitkosol R. Aeumjaturapat S. Jongkaewwattana A. Bunnag S. Pisitkun T.

Affiliations

Department of Medical Services National Cancer Institute Ministry of Public Health Bangkok Thailand; Faculty of Medicine Center of Excellence in Systems Biology Chulalongkorn University Bangkok Thailand; The Excellence Chulalongkorn Comprehensive Cancer Center King Chulalongkorn Memorial Hospital Bangkok Thailand; School of Arts and Sciences Tufts University Massachusetts United States; Department of Microbiology Faculty of Medicine Chulalongkorn University Bangkok Thailand; School of Medicine Faculty of Health and Medical Sciences The University of Western Australia Nedlands WA Australia; Department of Pharmacology Faculty of Veterinary Science Chulalongkorn University Bangkok Thailand; Faculty of Veterinary Science Veterinary Stem Cell and Bioengineering Innovation Center (VSCBIC) Chulalongkorn University Bangkok Thailand; Veterinary Stem Cell and Bioengineering Research Unit Faculty of Veterinary Science Chulalongkorn University Bangkok Thailand; Academic Affairs Faculty of Veterinary Science Chulalongkorn University Bangkok Thailand; Department of Medical Sciences Ministry of Public Health Nonthaburi Thailand; Department of Medical Sciences Institute of Biological Products Ministry of Public Health Nonthaburi Thailand; Faculty of Pharmacy Silpakorn University Nakhon Pathom Thailand; The Government Pharmaceutical Organization Bangkok Thailand; Virology and Cell Technology Research Team National Center for Genetic Engineering and Biotechnology (BIOTEC) National Science and Technology Development Agency (NSTDA) Pathumthani Thailand; Otolaryngology Department King Chulalongkorn Memorial Hospital Bangkok Thailand

Type

Article

Source Title

Scientific Reports

ISSN

20452322

Year

2023

Volume

13

Issue

1

Open Access

All Open Access Gold Green

Publisher

Nature Research

DOI

10.1038/s41598-023-42539-7

Abstract

An HPMC-based nasal spray solution containing human IgG1 antibodies against SARS-CoV-2 (nasal antibody spray or NAS) was developed to strengthen COVID-19 management. NAS exhibited potent broadly neutralizing activities against SARS-CoV-2 with PVNT50 values ranging from 0.0035 to 3.1997�g/ml for the following variants of concern (ranked from lowest to highest): Alpha Beta Gamma ancestral Delta Omicron BA.1 BA.2 BA.4/5 and BA.2.75. Biocompatibility assessment showed no potential biological risks. Intranasal NAS administration in rats showed no circulatory presence of human IgG1 anti-SARS-CoV-2 antibodies within 120爃. A double-blind randomized placebo-controlled trial (NCT05358873) was conducted on 36 healthy volunteers who received either NAS or a normal saline nasal spray. Safety of the thrice-daily intranasal administration for 7燿ays was assessed using nasal sinuscopy adverse event recording and self-reporting questionnaires. NAS was well tolerated with no significant adverse effects during the 14燿ays of the study. The SARS-CoV-2 neutralizing antibodies were detected based on the signal inhibition percent (SIP) in nasal fluids pre- and post-administration using a SARS-CoV-2 surrogate virus neutralization test. SIP values in nasal fluids collected immediately or 6 h after NAS application were significantly increased from baseline for all three variants tested including ancestral Delta and Omicron BA.2. In conclusion NAS was safe for intranasal use in humans to increase neutralizing antibodies in nasal fluids that lasted at least 6爃. ? 2023 Springer Nature Limited.

License

CC BY

Rights

Authors

Publication Source

WOS

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