Coronavirus vaccine

Patent metadata

Field	Value
Publication number	US-2024366751-A1
Application number	US-202318526938-A
Country	US
Kind code	A1
Filing date	Dec 1, 2023
Priority date	Jun 26, 2022
Publication date	Nov 7, 2024
Grant date	—

Abstract

This disclosure relates to the field of RNA to prevent or treat coronavirus infection. In particular, the present disclosure relates to methods and agents for vaccination against coronavirus infection and inducing effective coronavirus antigen-specific immune responses such as antibody and/or T cell responses.

First claim

1 .- 30 . (canceled)

31 . A method comprising administering to a subject:
(a) an RNA molecule having:
(i) a nucleotide sequence that is at least 99% identical to SEQ ID NO: 161; or
(ii) a nucleotide sequence that is at least 95% identical to SEQ ID NO: 161, and which encodes a SARS-CoV-2 Spike (S) protein comprising the following substitutions relative to SEQ ID NO: 1: T19I, Δ24-26, A27S, V83A, G142D, Δ145, H146Q, Q183E, V213E, G252V, G339H, R346T, L368I, S371F, S373P, S375F, T376A, D405N, R408S, K417N, N440K, V445P, G446S, N460K, S477N, T478K, E484A, F486P, F490S, Q498R, N501Y, Y505H, D614G, H655Y, N679K, P681H, N764K, D796Y, Q954H, N969K, K986P, and V987P; and
(b) an influenza vaccine; wherein the RNA molecule comprises a 5′ cap and a modified uridine in place of each uridine.

32 . The method of claim 31 , wherein the influenza vaccine is an inactivated influenza vaccine.

33 . The method of claim 32 , wherein the inactivated influenza vaccine is Fluzone®, Fluzone High-Dose Quadrivalent®, Fluzone Quadrivalent®, Fluzone Intradermal Quardivalent®, Fluzone Quadrivalent Southern Hemisphere®, Fluad®, Fluad Quadrivalent®, Afluria Quardivalent®, Fluarix Quadrivalent®, FluLaval Quadrivalent®, or Flucelvax Quadrivalent®.

34 . The method of claim 31 , wherein the influenza vaccine is a recombinant influenza vaccine.

35 . The method of claim 34 , wherein the recombinant influenza vaccine is Flublok Quadrivalent®.

36 . The method of claim 31 , wherein the influenza vaccine is a live attenuated influenza vaccine.

37 . The method of claim 36 , wherein the influenza vaccine is FluMist Quadrivalent®.

38 . The method of claim 31 , wherein the influenza vaccine is a non-adjuvanted influenza vaccine.

39 . The method of claim 31 , wherein the influenza vaccine is an adjuvanted influenza vaccine.

40 . The method of claim 31 , wherein the influenza vaccine is a subunit or split vaccine.

41 . The method of claim 31 , wherein the method further comprises administering an RSV vaccine.

42 . The method of claim 31 , wherein the modified uridine is N1-methyl-pseudouridine.

43 . The method of claim 31 , wherein the 5′ cap comprises m 2 7,3′-O Gppp(m 1 2′-O )ApG.

44 . The method of claim 31 , wherein the RNA molecule has a nucleotide sequence as set forth in SEQ ID NO: 161.

45 . The method of claim 31 , wherein the RNA molecule is encapsulated in a lipid nanoparticle (LNP).

46 . The method of claim 45 , wherein the LNP comprises molar ratios of 20-60% ionizable cationic lipid, 5-25% neutral lipid, 25-55% sterol, and 0.5-15% PEG-modified lipid.

47 . The method of claim 31 , wherein the composition comprises one or more additional RNA molecule(s), each having a nucleotide sequence encoding an S protein of a SARS-CoV-2 strain or variant that is not XBB.1.5.

48 . The method of claim 31 , wherein the RNA molecule has a nucleotide sequence as set forth in SEQ ID NO: 161, and wherein the RNA molecule comprises:
(1) N1-methyl-pseudouridine in place of each uridine; and (2) a 5′ cap that comprises m 2 7,3′-O Gppp(m 1 2′-O )ApG; wherein the RNA molecule is encapsulated in a lipid nanoparticle (LNP); wherein the LNP comprises molar ratios of 20-60% ionizable cationic lipid, 5-25% neutral lipid, 25-55% sterol, and 0.5-15% PEG-modified lipid; and wherein the influenza vaccine is Flublok Quadrivalent®.

49 . The method of claim 31 , wherein:
(1) the subject is 12 years or older, and the composition comprises 30 μg of the RNA molecule; (2) the subject is 5 years to less than 12 years old, and the composition comprises 10 μg of the RNA molecule; or (3) the subject is 6 months to less than 5 years old, and the composition comprises 3 μg of the RNA molecule.

50 . The method of claim 31 , wherein the subject was previously administered (i) one or more doses of a SARS-CoV-2 vaccine, or (ii) a complete dosing regimen of a SARS-CoV-2 vaccine.

Assignees

• BioNTech SE

Inventors

• Muik Alexander
• Poran Asaf
• Swanson Kena Anne
• Yang Qi
• Cai Hui
• Sahin Ugur
• Modjarrad Kayvon

Classifications

• C12N2770/20071

  Demonstrated in vivo effect · CPC title

• C12N2770/20034

  Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein · CPC title

• C12N2770/20022

  New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes · CPC title

• C07K14/005

  from viruses · CPC title

• A61K2039/70

  Multivalent vaccine · CPC title