NCT05200741 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Influenza Virus Vector COVID-19 Vaccine for Intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1) Phase III Clinical Trial - Investigator's Brochure (Version 2
0, Dated 02-Sep-2021).
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). pii: e02180-19. doi: 10.1128/mBio.02180-19.
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.

A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Immunogenicity of DelNS1-2019-nCoV-RBD-OPT1 as Booster Vaccine for COVID-19 in Healthy Adults Who Have Received 2 Doses of BNT162b2

Details for clinical trial NCT05200741

Clinical trial NCT05200741 - References