Nasal spray of an IgM-like ACE2 fusion protein HH-120 prevents SARS-CoV-2 infection: Two investigator-initiated postexposure prophylaxis trials.

Autor: Song R; Beijing Ditan Hospital, Capital Medical University, Beijing, China., Chen X; Beijing Ditan Hospital, Capital Medical University, Beijing, China., Li B; Beijing Ditan Hospital, Capital Medical University, Beijing, China., Ni J; Beijing Ditan Hospital, Capital Medical University, Beijing, China., Zhou Y; Beijing Ditan Hospital, Capital Medical University, Beijing, China., Zhang H; Huahui Health Ltd., Beijing, China., Liang X; Huahui Health Ltd., Beijing, China., Zou L; Huahui Health Ltd., Beijing, China., Liu J; Huahui Health Ltd., Beijing, China., Yang F; Huahui Health Ltd., Beijing, China., Li G; Huahui Health Ltd., Beijing, China., Guo X; Beijing Ditan Hospital, Capital Medical University, Beijing, China., Liu Z; Beijing Ditan Hospital, Capital Medical University, Beijing, China., Mao F; Huahui Health Ltd., Beijing, China., Lei C; Huahui Health Ltd., Beijing, China., Sui J; National Institute of Biological Sciences, Beijing, China.; Tsinghua Institute of Multidisciplinary Biomedical Research, Tsinghua University, Beijing, China., Li W; National Institute of Biological Sciences, Beijing, China.; Tsinghua Institute of Multidisciplinary Biomedical Research, Tsinghua University, Beijing, China., Jin R; Beijing Ditan Hospital, Capital Medical University, Beijing, China.; National Center for Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, China.; Beijing Key Laboratory of Emerging Infectious Diseases, Institute of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, China.
Jazyk: angličtina
Zdroj: Journal of medical virology [J Med Virol] 2023 Dec; Vol. 95 (12), pp. e29275.
DOI: 10.1002/jmv.29275
Abstrakt: HH-120, an IgM-like angiotensin converting enzyme 2 (ACE2) fusion protein, has been developed as a nasal spray against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and is currently undergoing human trials. HH-120 nasal spray was assessed for postexposure prophylaxis (PEP) in two investigator-initiated (NS01 and NS02) trials with different risk levels of SARS-CoV-2 exposure. NS01 enrolled family caregiver participants who had continuous contacts with laboratory-confirmed index cases; NS02 enrolled participants who had general contacts (Part 1) or close contacts (Part 2) with index cases. The primary endpoints were safety and laboratory-confirmed and/or symptomatic SARS-CoV-2 infection. In NS01 trial (14 participants), the SARS-CoV-2 infection rates were 25% in the HH-120 group and 83.3% in the external control group (relative risk reduction [RRR]: 70.0%). In NS02-Part 1 (193 participants), the infection rates were 4% (HH-120) versus 11.3% (placebo), symptomatic infection rates were 0.8% versus 3.5%, hence with a RRR of 64.6% and 77.1%, respectively. In Part 2 (76 participants), the infection rates were 17.1% (HH-120) versus 30.4% (placebo), symptomatic infection rates were 7.5% versus 27.3%, with a RRR of 43.8% and 72.5%, respectively. No HH-120-related serious adverse effects were observed. The HH-120 nasal spray used as PEP was safe and effective in preventing laboratory-confirmed and symptomatic SARS-CoV-2 infection.
(© 2023 The Authors. Journal of Medical Virology published by Wiley Periodicals LLC.)
Databáze: MEDLINE
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