The China National Intellectual Property Administration published on June 2, 2020 what may be the first patent application covering a vaccine for the COVID-19 virus. The Institute of Military Medicine, Chinese Academy of Military Sciences in conjunction with CanSinoBIO, a Chinese vaccine maker, filed application CN202010193587.8 on March 18, 2020 and is entitled “A new recombinant coronavirus vaccine using human replication-deficient adenovirus as a vector.” The patent application is based on research later published in the Lancet showing their Ad5 vectored COVID-19 vaccine “is tolerable and immunogenic at 28 days post-vaccination.” The vaccine is the first candidate vaccine to begin conducting Phase II human clinical trials.
The patent application claims a polynucleotide, vector of the polynucleotide, adenovirus, and method of manufacturing the adenovirus.
The unexamined claims follow:
1. A polynucleotide for coding a S protein of the 2019 novel coronavirus is characterized in that the sequence of the polynucleotide is shown as SEQ ID NO: 1.
2. A vector comprising the polynucleotide of claim 1.
3. The vector of claim 2, wherein the vector is pDC316.
4. A human replication-deficient recombinant adenovirus capable of expressing the polynucleotide of claim 1.
5. The recombinant adenovirus of claim 4, wherein the recombinant adenovirus is derived from an admax adenovirus system.
6. The use of the recombinant adenovirus of claims 4 and 5 in the preparation of a vaccine for the prevention of 2019 novel coronavirus.
7. The method of claim 6, wherein the recombinant adenovirus is formulated as an injection, nasal drop, or spray.
8. The use of claim 7, wherein the recombinant adenovirus is prepared as an intramuscular injection.
9. A method of preparing a recombinant adenovirus according to claim 4 or 5, said method comprising the steps of: (1) constructing a shuttle plasmid vector comprising a polynucleotide encoding a 2019 novel coronavirus s protein; (2) transfecting the shuttle plasmid vector and the skeleton plasmid of step (1) into the host cell; (3) culturing the host cell in step (2); (4) harvesting the human replication-deficient recombinant adenovirus released from the cells of step (3); (5) amplifying and culturing the recombinant adenovirus in step (4); (6) purifying the culture product in step (5).
10. The method of claim 9, wherein the vector of step (1) is pDC316.
11. The method of claim 9, wherein the backbone plasmid of step (2) is pBHGlox_E1, 3Cre.
12. The method of claim 9, wherein the cell of step (3) is an hek293 cell.
13. The method of claim 9, wherein the amplification culture method of step (5) is suspension culture.
14. The method of claim 9, wherein the purification method of step (6) is source 30q chromatography.
There is no word yet on whether the application has or will be foreign filed.