tetano
Editor, Senior Moderator
J Med Virol
. 2023 Dec;95(12):e29275.
doi: 10.1002/jmv.29275. Nasal spray of an IgM-like ACE2 fusion protein HH-120 prevents SARS-CoV-2 infection: Two investigator-initiated postexposure prophylaxis trials
Rui Song[SUP] 1 [/SUP], Xiaoyou Chen[SUP] 1 [/SUP], Baoliang Li[SUP] 1 [/SUP], Jun Ni[SUP] 1 [/SUP], Yunao Zhou[SUP] 1 [/SUP], Hongbin Zhang[SUP] 2 [/SUP], Xiao Liang[SUP] 2 [/SUP], Liangfeng Zou[SUP] 2 [/SUP], Juan Liu[SUP] 2 [/SUP], Fang Yang[SUP] 2 [/SUP], Guangyu Li[SUP] 2 [/SUP], Xiaodi Guo[SUP] 1 [/SUP], Zhe Liu[SUP] 1 [/SUP], Fengfeng Mao[SUP] 2 [/SUP], Cong Lei[SUP] 2 [/SUP], Jianhua Sui[SUP] 3 4 [/SUP], Wenhui Li[SUP] 3 4 [/SUP], Ronghua Jin[SUP] 1 5 6 [/SUP]
Affiliations
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.
Keywords: HH-120; SARS-CoV-2; nasal spray; postexposure prophylaxis, PEP.
. 2023 Dec;95(12):e29275.
doi: 10.1002/jmv.29275. Nasal spray of an IgM-like ACE2 fusion protein HH-120 prevents SARS-CoV-2 infection: Two investigator-initiated postexposure prophylaxis trials
Rui Song[SUP] 1 [/SUP], Xiaoyou Chen[SUP] 1 [/SUP], Baoliang Li[SUP] 1 [/SUP], Jun Ni[SUP] 1 [/SUP], Yunao Zhou[SUP] 1 [/SUP], Hongbin Zhang[SUP] 2 [/SUP], Xiao Liang[SUP] 2 [/SUP], Liangfeng Zou[SUP] 2 [/SUP], Juan Liu[SUP] 2 [/SUP], Fang Yang[SUP] 2 [/SUP], Guangyu Li[SUP] 2 [/SUP], Xiaodi Guo[SUP] 1 [/SUP], Zhe Liu[SUP] 1 [/SUP], Fengfeng Mao[SUP] 2 [/SUP], Cong Lei[SUP] 2 [/SUP], Jianhua Sui[SUP] 3 4 [/SUP], Wenhui Li[SUP] 3 4 [/SUP], Ronghua Jin[SUP] 1 5 6 [/SUP]
Affiliations
- PMID: 38054556
- DOI: 10.1002/jmv.29275
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.
Keywords: HH-120; SARS-CoV-2; nasal spray; postexposure prophylaxis, PEP.