A Study to Evaluate Safety and Immunogenicity of DelNS1-nCoV-RBD LAIV for COVID-19

Summary

To investigate the safety and immunogenicity profile of of a novel nasal spray investigational vaccine, which is a potential prophylactic vaccine for current pandemic disease COVID-19.

Timeline

Start

2021-03-29

Primary completion

2022-09

Completion

2022-09

Publications

• Background Mossler C, Groiss F, Wolzt M, Wolschek M, Seipelt J, Muster T. Phase I/II trial of a replication-deficient trivalent influenza virus vaccine lacking NS1. Vaccine. 2013 Dec 16;31(52):6194-200. doi: 10.1016/j.vaccine.2013.10.061. Epub 2013 Oct 30.
• Background Surichan S, Wirachwong P, Supachaturas W, Utid K, Theerasurakarn S, Langsanam P, Lakornrach P, Nitisaporn L, Chansikkakorn C, Vangkanonta W, Kaweepornpoj R, Poopipatpol K, Thirapakpoomanunt S, Srichainak S, Artavatkun W, Chokevivat V, Wibulpolprasert S. Development of influenza vaccine production capacity by the Government Pharmaceutical Organization of Thailand: addressing the threat of an influenza pandemic. Vaccine. 2011 Jul 1;29 Suppl 1:A29-33. doi: 10.1016/j.vaccine.2011.04.120.
• Background Wacheck V, Egorov A, Groiss F, Pfeiffer A, Fuereder T, Hoeflmayer D, Kundi M, Popow-Kraupp T, Redlberger-Fritz M, Mueller CA, Cinatl J, Michaelis M, Geiler J, Bergmann M, Romanova J, Roethl E, Morokutti A, Wolschek M, Ferko B, Seipelt J, Dick-Gudenus R, Muster T. A novel type of influenza vaccine: safety and immunogenicity of replication-deficient influenza virus created by deletion of the interferon antagonist NS1. J Infect Dis. 2010 Feb 1;201(3):354-62. doi: 10.1086/649428.
• Background Wang P, Zheng M, Lau SY, Chen P, Mok BW, Liu S, Liu H, Huang X, Cremin CJ, Song W, Chen Y, Wong YC, Huang H, To KK, Chen Z, Xia N, Yuen KY, Chen H. Generation of DelNS1 Influenza Viruses: a Strategy for Optimizing Live Attenuated Influenza Vaccines. mBio. 2019 Sep 17;10(5):e02180-19. doi: 10.1128/mBio.02180-19.
• Background Zheng M, Wang P, Song W, Lau SY, Liu S, Huang X, Mok BW, Liu YC, Chen Y, Yuen KY, Chen H. An A14U Substitution in the 3' Noncoding Region of the M Segment of Viral RNA Supports Replication of Influenza Virus with an NS1 Deletion by Modulating Alternative Splicing of M Segment mRNAs. J Virol. 2015 Oct;89(20):10273-85. doi: 10.1128/JVI.00919-15. Epub 2015 Jul 29.

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Indications