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

Author

Thanarath Imsuwansri, Thitinan Jongthitinon, Niramon Pojdoung, Nuntana Meesiripan, Siriwan Sakarin, Chatikorn Boonkrai, Tossapon Wongtangprasert, Tanapati Phakham, Thittaya Audomsun, Chadaporn Attakitbancha, Pijitra Saelao, Phijitra Muanwien, Maoxin Tim Tian, Songsak Tongchusak, Bhrus Sangruji, Dhammika Leshan Wannigama, Chenphop Sawangmake, Watchareewan Rodprasert, Quynh Dang Le, Steven Dwi Purbantoro, Kananuch Vasuntrarak, Sirirat Nantavisai, Supakit Sirilak, Ballang Uppapong, Sompong Sapsutthipas, Sakalin Trisiriwanich, Thitiporn Somporn, Asmah Usoo, Natthakarn Mingngamsup, Supaporn Phumiamorn, Porawan Aumklad, Kwanputtha Arunprasert, Prasopchai Patrojanasophon, Praneet Opanasopit, Norapath Pesirikan, Ladda Nitisaporn, Jesada Pitchayakorn, Thana Narkthong, Bancha Mahong, Kumchol Chaiyo, Kanjana Srisutthisamphan, Ratchanont Viriyakitkosol, Songklot Aeumjaturapat, Anan Jongkaewwattana, Sakarn Bunnag, and Trairak Pisitkun

Subjects
Medicine, Science
Abstract

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 μg/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 h. 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 days was assessed using nasal sinuscopy, adverse event recording, and self-reporting questionnaires. NAS was well tolerated, with no significant adverse effects during the 14 days 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 h.

Published
2023
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2. A randomized, placebo-controlled trial of a nasal spray solution containing broadly potent neutralizing antibodies against SARS-CoV-2 variants in healthy volunteers

Author

Thanarath Imsuwansri, Thitinan Jongthitinon, Niramon Pojdoung, Nuntana Meesiripan, Siriwan Sakarin, Chatikorn Boonkrai, Tossapon Wongtangprasert, Tanapati Phakham, Thittaya Audomsun, Chadaporn Attakitbancha, Pijitra Saelao, Phijitra Muanwien, Maoxin Tim Tian, Songsak Tongchusak, Bhrus Sangruji, Dhammika Leshan Wannigama, Chenphop Sawangmake, Watchareewan Rodprasert, Quynh Dang Le, Steven Dwi Purbantoro, Kananuch Vasuntrarak, Sirirat Nantavisai, Supakit Sirilak, Ballang Uppapong, Sompong Sapsutthipas, Sakalin Trisiriwanich, Thitiporn Somporn, Asmah Usoo, Natthakarn Mingngamsup, Supaporn Phumiamorn, Porawan Aumklad, Kwanputtha Arunprasert, Prasopchai Patrojanasophon, Praneet Opanasopit, Norapath Pesirikan, Ladda Nitisaporn, Jesada Pitchayakorn, Thana Narkthong, Bancha Mahong, Kumchol Chaiyo, Kanjana Srisuthisamphan, Ratchanont Viriyakitkosol, Songklot Aeumjaturapat, Anan Jongkaewwattana, Sakarn Bunnag, and Trairak Pisitkun

Abstract

Successful COVID-19 prevention requires additional measures beyond vaccination, social distancing, and masking. A nasal spray solution containing human IgG1 antibodies against SARS-CoV-2 (COVITRAP™) was developed to strengthen other COVID-19 preventive arsenals. Here, we evaluated its pseudovirus neutralization potencies, preclinical and clinical safety profiles, and intranasal SARS-CoV-2 inhibitory effects in healthy volunteers (NCT05358873). COVITRAP™ exhibited broadly potent neutralizing activities against SARS-CoV-2 with PVNT50 values ranging from 0.0035 to 3.1997 μg/ml for the following variants of concern (ranked from lowest to highest): Alpha, Beta, Gamma, Ancestral, Delta, Omicron BA.1, Omicron BA.2, Omicron BA.4/5, and Omicron BA.2.75. It demonstrated satisfactory preclinical safety profiles based on evaluations of in vitro cytotoxicity, skin sensitization, intracutaneous reactivity, and systemic toxicity. Its intranasal administration in rats did not yield any detected circulatory levels of the human IgG1 anti-SARS-CoV-2 antibodies at any time point during the 120 hours of follow-up. A double-blind, randomized, placebo-controlled trial (RCT) was conducted on 36 healthy volunteers who received either COVITRAP™ or a normal saline nasal spray at a 3:1 ratio. Safety of the thrice-daily intranasal administration for 7 days was assessed using nasal sinuscopy, adverse event recording, and self-reporting questionnaires. COVITRAP™ was well tolerated, with no significant adverse effects in healthy volunteers for the entire 14 days of the study. The intranasal SARS-CoV-2 inhibitory effects of COVITRAP™ were evaluated in nasal fluids taken from volunteers pre- and post-administration using a SARS-CoV-2 surrogate virus neutralization test. SARS-CoV-2 inhibitory effects in nasal fluids collected immediately or six hours after COVITRAP™ application were significantly increased from baseline for all three variants tested, including Ancestral, Delta, and Omicron BA.2. In conclusion, COVITRAP™ was safe for intranasal use in humans to provide SARS-CoV-2 inhibitory effects in nasal fluids that lasted at least six hours. Therefore, COVITRAP™ can be considered an integral instrument for COVID-19 prevention.

Published
2022

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