IP Library Granted Patent US 12,605,437
Granted Patent B2
US 12,605,437 · App. 17/632,946 · Granted Apr 21, 2026

Single shot Chikungunya virus vaccine

Inventors: Nina Wressnigg (Gießhübl, AT); Romana Hochreiter (Vienna, AT)
Assignee: Valneva SE
A61K39/12A61P31/14A61K2039/5254C12N2770/36134
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Quick Facts
Patent No.
US 12,605,437
App. No.
17/632,946
Granted
Apr 21, 2026
Kind
B2
Abstract

The present invention relates to a single-shot live attenuated vaccine against Chikungunya virus which is well-tolerated and induces long-lasting protective immunity in adult human subjects.

Claims (18)

1 . A lyophilized pharmaceutical unit dosage composition lyophilized from a composition comprising a) an attenuated Chikungunya virus (CHIKV); b) 5% (w/v) sucrose; c) 5 mM potassium phosphate; d) 25 mM sodium citrate; e) 5 mM MgCl 2 ; f) 0.5% (w/v) D-sorbitol; g) 10 mM L-methionine; and h) 0.01% (w/v) recombinant human serum albumin (rHSA), wherein said unit dosage composition comprises 10 3 to 5×10 4 TCID 50 /dose, and wherein said attenuated CHIKV comprises an RNA genome corresponding to the DNA sequence as defined by SEQ ID NO: 1 (CHIKV-Δ5nsP3) and/or one or more variants thereof, wherein said variant has a nucleic acid sequence that is at least 99% identical to SEQ ID NO: 1 and has the entire 60 amino acid deletion in nsP3 as in SEQ ID NO: 1.

2 . The pharmaceutical composition according to claim 1 , wherein said unit dosage comprises 10 3 to 2×10 4 TCID 50 /dose.

3 . The pharmaceutical composition according to claim 1 , wherein said dosage is 5×10 3 TCID 50 /dose.

4 . The pharmaceutical composition according to claim 1 , wherein said attenuated CHIKV variant expresses an E2 protein with at least one mutation compared with the wild-type E2 protein as defined by SEQ ID NO: 2.

5 . The pharmaceutical composition according to claim 1 , wherein said attenuated CHIKV variant expresses an E2 protein with an E168K mutation as defined by SEQ ID NO: 3.

6 . The pharmaceutical composition according to claim 1 for use as a one-shot vaccine for the prevention or treatment of CHIKV infection.

7 . The pharmaceutical composition according to claim 1 , wherein said CHIKV variant expresses an E2 protein as defined by any of SEQ ID Nos: 3-7.

8 . The pharmaceutical composition according to claim 1 , wherein said composition is able to increase serum antibody titers to said virus in a human by at least 1 log relative to a control within 14 days from primary immunization.

9 . The pharmaceutical composition according to claim 1 , wherein said composition is able to increase serum antibody titers to said virus in a human by at least 1 log relative to a control within 7 days from primary immunization.

10 . The pharmaceutical composition according to claim 1 , wherein said composition is able to stimulate seroconversion in at least 25%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, at least 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, up to 100% of vaccinated subjects within 7 days of vaccination, wherein seroconversion is defined as reaching a neutralizing CHIKV antibody titer of at least 10.

11 . The pharmaceutical composition according to claim 1 , wherein said composition is able to stimulate seroconversion in at least 25%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, at least 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, up to 100% of vaccinated subjects within 14 days of vaccination, wherein seroconversion is defined as reaching a neutralizing CHIKV antibody titer of at least 10.

12 . The pharmaceutical composition according to claim 1 , wherein said composition is able to induce a protective immune response which lasts for at least 6 months.

13 . The pharmaceutical composition according to claim 1 , wherein said composition is able to induce a protective immune response which lasts for at least 12 months.

14 . The pharmaceutical composition according to claim 1 , wherein said composition is able to induce a protective immune response which lasts for at least 24 months.

15 . The pharmaceutical composition according to claim 1 , wherein said composition is able to induce a protective immune response which confers life-long protection against CHIKV disease.

16 . The pharmaceutical composition according to claim 1 , for use in a method of treating or preventing a CHIKV infection.

17 . The pharmaceutical composition according to claim 10 , wherein seroconversion is defined as reaching a neutralizing CHIKV antibody titer of at least 20.

18 . The pharmaceutical composition according to claim 11 , wherein seroconversion is defined as reaching a neutralizing CHIKV antibody titer of at least 20.

Assignments (4)
RELEASE OF SECURITY INTEREST Recorded Nov 10, 2025
From: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT
To: VALNEVA AUSTRIA GMBH; VALNEVA SE; VALNEVA USA, INC.
Reel/Frame 073516/0522 →
PATENT SECURITY AGREEMENT Recorded Oct 20, 2025
From: VALNEVA AUSTRIA GMBH; VALNEVA SE; VALNEVA SWEDEN AB
To: BIOPHARMA CREDIT PLC, AS COLLATERAL AGENT
Reel/Frame 073164/0032 →
SECURITY INTEREST Recorded Jan 19, 2024
From: VALNEVA SE; VALNEVA AUSTRIA GMBH; VALNEVA USA, INC.; VALNEVA SWEDEN AB
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 066182/0174 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 31, 2022
From: WRESSNIGG, NINA; HOCHREITER, ROMANA
To: VALNEVA SE
Reel/Frame 060951/0079 →
Priority Claims (2)
EP 19191030 · Aug 9, 2019 · regional
EP 20158557 · Feb 20, 2020 · regional
Continuity (1)
Related Publication 20220313810A1 · Oct 6, 2022
References Cited (45)
US 20170014502A1 · Sumathy et al. · 2017 [cited by applicant]
WO WO1998013065A1 · 1998 [cited by applicant]
WO WO2017109223A1 · 2017 [cited by applicant]
WO WO2017109224A1 · 2017 [cited by applicant]
WO WO2017172643A1 · 2017 [cited by applicant]
WO WO2019057793A1 · 2019 [cited by applicant]
[No Author Listed], Structural polyprotein. Chikungunya virus (CHIKV). UNIPROT Accession No. D2KBQ0. Feb. 9, 2010. Accessible at https://www.uniprot.org/uniprotkb/D2KBQ0/entry. 3 pages. [cited by applicant]
Hallengärd et al., Novel attenuated Chikungunya vaccine candidates elicit protective immunity in C57BL/6 mice. J Virol. Mar. 2014;88(5):2858-66. doi: 10.1128/JVI.03453-13. Epub Dec. 26, 2013. [cited by applicant]
Milligan et al., Defining a correlate of protection for chikungunya virus vaccines. Vaccine. Nov. 28, 2019;37(50):7427-7436. doi: 10.1016/j.vaccine.2018.10.033. Epub Nov. 15, 2018. [cited by applicant]
Roques et al., Effectiveness of CHIKV vaccine VLA1553 demonstrated by passive transfer of human sera. JCI Insight. Jul. 22, 2022;7(14):e160173. doi: 10.1172/jci.insight.160173. 16 pages. [cited by applicant]
Zheng et al., Genetic analysis of chikungunya viruses imported to mainland China in 2008. Virol J. Jan. 18, 2010;7:8. doi: 10.1186/1743-422X-7-8. 6 pages. [cited by applicant]
PCT/EP2020/072435, Dec. 3, 2020, International Search Report and Written Opinion. [cited by applicant]
PCT/EP2020/072435, Feb. 17, 2022, International Preliminary Report on Patentability. [cited by applicant]
PCT/EP2020/072436, Dec. 3, 2020, International Search Report and Written Opinion. [cited by applicant]
PCT/EP2020/072436, Feb. 17, 2022, International Preliminary Report on Patentability. [cited by applicant]
[No Author Listed], Declaration of Helsinki. Bulletin of the World Health Organization. 2001;79(4):373-4. [cited by applicant]
[No Author Listed], International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use / Guideline for Good Clinical Practice. 1996. 59 pages. [cited by applicant]
[No Author Listed], Number of reported cases of chikungunya fever in the Americas by country or territory. World Health Organization. 2013-2016. Accessible at http://www.paho.org/hq/index.php?option=com_topics. 1 page. [cited by applicant]
[No Author Listed], Valneva Reports Positive 24-Month Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ®. Valneva SE. Dec. 4, 2023. 5 pages. [cited by applicant]
Ahola et al., Therapeutics and vaccines against chikungunya virus. Vector Borne Zoonotic Dis. Apr. 2015;15(4):250-7. doi: 10.1089/vbz.2014.1681. Erratum in: Vector Borne Zoonotic Dis. Nov. 2015;15(11):712. Courderc, The… [cited by applicant]
Bandeira et al., Prolonged shedding of Chikungunya virus in semen and urine: A new perspective for diagnosis and implications for transmission. IDCases. Nov. 4, 2016;6:100-103. doi: 10.1016/j.idcr.2016.10.007. [cited by applicant]
Broeckel et al., Therapeutic administration of a recombinant human monoclonal antibody reduces the severity of chikungunya virus disease in rhesus macaques. PLoS Negl Trop Dis. Jun. 19, 2017;11(6):e0005637. doi: 10.1371… [cited by applicant]
Chang et al., Effect of sorbitol and residual moisture on the stability of lyophilized antibodies: Implications for the mechanism of protein stabilization in the solid state. J Pharm Sci. Jul. 2005;94(7):1445-55. doi: 1… [cited by applicant]
Chu et al., Deciphering the protective role of adaptive immunity to CHIKV/IRES a novel candidate vaccine against Chikungunya in the A129 mouse model. Vaccine. Jul. 18, 2013;31(33):3353-60. doi: 10.1016/j.vaccine.2013.05… [cited by applicant]
Couderc et al., Prophylaxis and therapy for Chikungunya virus infection. J Infect Dis. Aug. 15, 2009;200(4):516-23. doi: 10.1086/600381. [cited by applicant]
Galatas et al., Long-Lasting Immune Protection and Other Epidemiological Findings after Chikungunya Emergence in a Cambodian Rural Community, Apr. 2012. PLoS Negl Trop Dis. Jan. 11, 2016;10(1):e0004281. doi: 10.1371/jou… [cited by applicant]
Gérardin et al., Chikungunya virus-associated encephalitis: A cohort study on La Réunion Island, 2005-2009. Neurology. Jan. 5, 2016;86(1):94-102. doi: 10.1212/WNL.0000000000002234. Epub Nov. 25, 2015. [cited by applicant]
Kam et al., Early neutralizing IgG response to Chikungunya virus in infected patients targets a dominant linear epitope on the E2 glycoprotein. EMBO Mol Med. Apr. 2012;4(4):330-43. doi: 10.1002/emmm.201200213. Epub Mar.… [cited by applicant]
Linn et al., Alphavirus-specific cytotoxic T lymphocytes recognize a cross-reactive epitope from the capsid protein and can eliminate virus from persistently infected macrophages. J Virol. Jun. 1998;72(6):5146-53. doi: … [cited by applicant]
Lum et al., An essential role of antibodies in the control of Chikungunya virus infection. J Immunol. Jun. 15, 2013;190(12):6295-302. doi: 10.4049/jimmunol.1300304. Epub May 13, 2013. [cited by applicant]
Musso et al., Detection of chikungunya virus in saliva and urine. Virol J. Jun. 16, 2016;13:102. doi: 10.1186/s12985-016-0556-9. Erratum in: Virol J. 2016;13(1):120. [cited by applicant]
Muturi-Kioi et al., Neutropenia as an Adverse Event following Vaccination: Results from Randomized Clinical Trials in Healthy Adults and Systematic Review. PLoS One. Aug. 4, 2016;11(8):e0157385. doi: 10.1371/journal.pon… [cited by applicant]
Nitatpattana et al., Long-term persistence of Chikungunya virus neutralizing antibodies in human populations of North Eastern Thailand. Virol J. Oct. 21, 2014;11:183. doi: 10.1186/1743-422X-11-183. [cited by applicant]
Pal et al., Development of a highly protective combination monoclonal antibody therapy against Chikungunya virus. PLoS Pathog. 2013;9(4):e1003312. doi: 10.1371/journal.ppat.1003312. Epub Apr. 18, 2013. 16 pages. [cited by applicant]
Panning et al., Chikungunya fever in travelers returning to Europe from the Indian Ocean region, 2006. Emerg Infect Dis. Mar. 2008;14(3):416-22. doi: 10.3201/eid1403.070906. [cited by applicant]
Pastorino et al., Development of a TaqMan RT-PCR assay without RNA extraction step for the detection and quantification of African Chikungunya viruses. J Virol Methods. Mar. 2005;124(1-2):65-71. doi: 10.1016/j.jviromet.… [cited by applicant]
Reed et al., A simple method of estimating fifty percent endpoints. Am J Hygiene. 1938;27:493-497. [cited by applicant]
Reisinger et al., Immunogenicity, safety, and tolerability of the measles-vectored chikungunya virus vaccine MV-CHIK: a double-blind, randomised, placebo-controlled and active-controlled phase 2 trial. Lancet. Dec. 22, … [cited by applicant]
Roques et al., Attenuated and vectored vaccines protect nonhuman primates against Chikungunya virus. JCI Insight. Mar. 23, 2017;2(6):e83527. doi: 10.1172/jci.insight.83527. [cited by applicant]
Schwartz et al., Formulation and Stability of a Chikungunya Virus-Like Particle (ChikV VLP) Based Vaccine. From Vaccine Technology IV. University College London, UK. Wyeth Vaccine Research Eds, ECI Symposium Series. Acc… [cited by applicant]
Vega-Rúa et al., Chikungunya virus transmission potential by local Aedes mosquitoes in the Americas and Europe. PLoS Negl Trop Dis. May 20, 2015;9(5):e0003780. doi: 10.1371/journal.pntd.0003780. 18 pages. [cited by applicant]
Weaver, Arrival of chikungunya virus in the new world: prospects for spread and impact on public health. PLoS Negl Trop Dis. Jun. 26, 2014;8(6):e2921. doi: 10.1371/journal.pntd.0002921. 4 pages. [cited by applicant]
Wressnigg et al., Single-shot live-attenuated chikungunya vaccine in healthy adults: a phase 1, randomised controlled trial. Lancet Infect Dis. Oct. 2020;20(10):1193-1203. doi: 10.1016/S1473-3099(20)30238-3. Epub Jun. 1… [cited by applicant]
Xie et al., Mechanism of the stabilization of ribonuclease A by sorbitol: preferential hydration is greater for the denatured then for the native protein. Protein Sci. Jan. 1997;6(1):211-21. doi: 10.1002/pro.5560060123. [cited by applicant]
Yoon et al., High rate of subclinical chikungunya virus infection and association of neutralizing antibody with protection in a prospective cohort in the Philippines. PLoS Negl Trop Dis. May 7, 2015;9(5):e0003764. doi: … [cited by applicant]