The efficacy and safety of an intranasal spray COVID-19 vaccine in a randomized double-blind placebo-controlled phase Ⅲ trial during Omicron period

Abstract

The live-attenuated influenza virus vector-based intranasal vaccine (dNS1-RBD, Pneucolin®) is the world’s first COVID-19 mucosal vaccine to enter human trials, and has been issued for emergency use authorization in China. Here, we report safety and efficacy data from a multi-centre randomized, double-blind, placebo-controlled phase 3 clinical trial of Pneucolin® (two doses, 14 days apart) in adults (18 years and older) during the Omicron circulation. The result showed a favorable safety profile, with no difference in the incidence of adverse reactions between the vaccine and placebo groups. In the per-protocol set, for symptomatic COVID-19, the efficacies among total population, naïve participants, particiants with inactivated vacciantion history were 32.6% (95%CI 8.2 to 50.5), 55.2% (95%CI 13.8 to 76.7), 38.2% (95%CI -49.2 to 74.4) , and for symptomatic COVID-19 with three or more of the suspected symptoms, the efficacies were 42.3% (95%CI 15.7 to 60.5), 66.7% (95%CI 8.3 to 87.9) and 63.1% (95%CI -15.8 to 88.3) for the above mentioned 3 cohorts. An efficacy of 100.0% (95%CI -9.2 to 100.0) against hospitalized COVID-19 was observed in the whole enrolled population. We conclude that Pneucolin® is well-tolerated and can be an antibody-independent broad-spectrum effective tool to combat SARS-CoV-2 variants, as primary immunization or heterologous booster.

Intranasal influenza-vectored COVID-19 vaccine restrains the SARS-CoV-2 inflammatory response in hamsters

“…In phases I and II clinical trials, the vaccine demonstrated an immunogenicity pattern that was highly consistent with animal studies-a weak peripheral immune response 20 . In recent phase III clinical trial results, this intranasal COVID-19 vaccine exhibited an encouraging efficacy combined with great safety profiles in the elderly or population with underlying chronic disease 21 . Thrillingly, this vaccine was approved for emergency use in China on December 2, 2022, named Pneucolin.…”

“…We previously developed an intranasal vaccine based on the NS1-deleted H1N1 vector carrying the gene encoding SARS-CoV-2-RBD (dNS1-RBD) 19,20 . A randomized placebo-controlled phase III clinical trial demonstrated that the vaccine has a good safety and broad-spectrum efficacy against Omicron symptomatic infection 21 [ChiCTR2100051391], and was approved for emergency use in China on December 2, 2022, named Pneucolin. This vaccine prevents COVID-19 induced by Prototype, Beta and Omicron of SARS-CoV-2 challenge in hamster models in the absence of detectable neutralizing antibodies 19 .…”

Acceptability for the influenza virus vector COVID-19 vaccine for intranasal spray: A cross-sectional survey in Beijing, China

“…The positive results of the Phase 3 clinical trial for this vaccine may help improve the vaccine confidence of the public, which have been posted as a preprint on Research Square after our study period. 20 …”

“…18 The phase III clinical trial also shows that this vaccine is well-tolerated and can be an antibody-independent broad-spectrum effective tool to combat SARS-CoV-2 variants. 19 , 20 This vaccine is applicable for people 18 years of age and older, including those who have not been immunized against any COVID-19 vaccine, and those who have received one, two, or three previous doses of other COVID-19 vaccines according to the vaccine instruction.…”