Safety and immunogenicity of the investigational V184 chikungunya vaccine will be tested in participants with history of chikungunya infection. Initially 21 to 50 year old participants will be enrolled; after favorable review of safety data, participants aged 51 to 65 will be enrolled.

Start Date16 Jul 2019

Sponsor / Collaborator

Themis Bioscience GmbH

[+1]

NCT03635086

/ CompletedPhase 2

Observer Blinded, Randomised Study to Investigate Safety, Tolerability and Long-term Immunogenicity of Different Dose Regimens and Formulations of MV-CHIK in Healthy Volunteers

The purpose of this study is to investigate immunogenicity and safety of Measles Virus-Chikungunya (MV-CHIK) vaccine in different dose regimens, 28 days after one or two vaccinations.

Start Date22 Aug 2018

Sponsor / Collaborator

Themis Bioscience GmbH

NCT03101111

/ CompletedPhase 2

Phase 2 Study of a Live Attenuated Measles Virus-Vectored Chikungunya Vaccine in a Previously Epidemic Area

The clinical study primarily assesses the safety of MV-CHIK a new Chikungunya vaccine in a previously epidemic area in healthy volunteers. Secondarily, immune response and viremia will be assessed.
MV-CHIK will be compared to the commercially available MMR vaccine. 80% of the subjects will receive MV-CHIK; 20% will receive MMR vaccine.

Start Date09 Aug 2017

Sponsor / Collaborator

Themis Bioscience GmbH

[+1]

100 Clinical Results associated with Chikungunya virus vaccine(Themis Bioscience GmbH)

100 Translational Medicine associated with Chikungunya virus vaccine(Themis Bioscience GmbH)

100 Patents (Medical) associated with Chikungunya virus vaccine(Themis Bioscience GmbH)

Literatures (Medical) associated with Chikungunya virus vaccine(Themis Bioscience GmbH)

01 Nov 2024·BioDrugs

Chikungunya Virus Vaccines: A Review of IXCHIQ and PXVX0317 from Pre-Clinical Evaluation to Licensure

Review

Author: Weber, Whitney C ; Streblow, Daniel N ; Coffey, Lark L

Chikungunya virus is an emerging mosquito-borne alphavirus that causes febrile illness and arthritic disease. Chikungunya virus is endemic in 110 countries and the World Health Organization estimates that it has caused more than 2 million cases of crippling acute and chronic arthritis globally since it re-emerged in 2005. Chikungunya virus outbreaks have occurred in Africa, Asia, Indian Ocean islands, South Pacific islands, Europe, and the Americas. Until recently, no specific countermeasures to prevent or treat chikungunya disease were available. To address this need, multiple vaccines are in human trials. These vaccines use messenger RNA-lipid nanoparticles, inactivated virus, and viral vector approaches, with a live-attenuated vaccine VLA1553 and a virus-like particle PXVX0317 in phase III testing. In November 2023, the US Food and Drug Administration (FDA) approved the VLA1553 live-attenuated vaccine, which is marketed as IXCHIQ. In June 2024, Health Canada approved IXCHIQ, and in July 2024, IXCHIQ was approved by the European Commission. On August 13, 2024, the US FDA granted priority review for PXVX0317. The European Medicine Agency is considering accelerated assessment review of PXVX0317, with potential for approval by both agencies in 2025. In this review, we summarize published data from pre-clinical and clinical trials for the IXCHIQ and PXVX0317 vaccines. We also discuss unanswered questions including potential impacts of pre-existing chikungunya virus immunity on vaccine safety and immunogenicity, whether long-term immunity can be achieved, safety in children, pregnant, and immunocompromised individuals, and vaccine efficacy in people with previous exposure to other emerging alphaviruses in addition to chikungunya virus.

29 Feb 2024·Journal of General Virology

Immunogenicity, safety and duration of protection afforded by chikungunya virus vaccines undergoing human clinical trials

Review

Author: Erku, Daniel ; Taylor, Adam ; Rao, Shambhavi ; Mahalingam, Suresh

Background. Chikungunya virus (CHIKV) causes chikungunya fever and has been responsible for major global epidemics of arthritic disease over the past two decades. Multiple CHIKV vaccine candidates are currently undergoing or have undergone human clinical trials, with one vaccine candidate receiving FDA approval. This scoping review was performed to evaluate the ‘efficacy’, ‘safety’ and ‘duration of protection’ provided by CHIKV vaccine candidates in human clinical trials.Methods. This scoping literature review addresses studies involving CHIKV vaccine clinical trials using available literature on the PubMed, Medline Embase, Cochrane Library and Clinicaltrial.gov databases published up to 25 August 2023. Covidence software was used to structure information and review the studies included in this article.Results. A total of 1138 studies were screened and, after removal of duplicate studies, 12 relevant studies were thoroughly reviewed to gather information. This review summarizs that all seven CHIKV vaccine candidates achieved over 90 % seroprotection against CHIKV after one or two doses. All vaccines were able to provide neutralizing antibody protection for at least 28 days.Conclusions. A variety of vaccine technologies have been used to develop CHIKV vaccine candidates. With one vaccine candidate having recently received FDA approval, it is likely that further CHIKV vaccines will be available commercially in the near future.

01 Oct 2023·Vaccine

A measles virus-based vaccine induces robust chikungunya virus-specific CD4+ T-cell responses in a phase II clinical trial

Article

Author: de Swart, Rik L ; Sette, Alessandro ; Geers, Daryl ; Comvalius, Anouskha D ; Schmitz, Katharina S ; de Vries, Rory D ; Nieuwkoop, Nella J ; Tschismarov, Roland ; Ramsauer, Katrin ; Weiskopf, Daniela

Chikungunya virus (CHIKV) is an alphavirus transmitted by mosquitos that causes a debilitating disease characterized by fever and long-lasting polyarthralgia. To date, no vaccine has been licensed, but multiple vaccine candidates are under evaluation in clinical trials. One of these vaccines is based on a measles virus vector encoding for the CHIKV structural genes C, E3, E2, 6K, and E1 (MV-CHIK), which proved safe in phase I and II clinical trials and elicited CHIKV-specific antibody responses in adult measles seropositive vaccine recipients. Here, we predicted T-cell epitopes in the CHIKV structural genes and investigated whether MV-CHIK vaccination induced CHIKV-specific CD4⁺ and/or CD8⁺ T-cell responses. Immune-dominant regions containing multiple epitopes in silico predicted to bind to HLA class II molecules were found for four of the five structural proteins, while no such regions were predicted for HLA class I. Experimentally, CHIKV-specific CD4⁺ T-cells were detected in six out of twelve participants after a single MV-CHIK vaccination and more robust responses were found 4 weeks after two vaccinations (ten out of twelve participants). T-cells were mainly directed against the three large structural proteins C, E2 and E1. Next, we sorted and expanded CHIKV-specific T cell clones (TCC) and identified human CHIKV T-cell epitopes by deconvolution. Interestingly, eight out of nine CD4⁺ TCC recognized an epitope in accordance with the in silico prediction. CHIKV-specific CD8⁺ T-cells induced by MV-CHIK vaccination were inconsistently detected. Our data show that the MV-CHIK vector vaccine induced a functional transgene-specific CD4⁺ T cell response which, together with the evidence of neutralizing antibodies as correlate of protection for CHIKV, makes MV-CHIK a promising vaccine candidate in the prevention of chikungunya.

News (Medical) associated with Chikungunya virus vaccine(Themis Bioscience GmbH)

21 Feb 2024

·www.biospace.com

Bavarian Nordic Puts Kibosh on Cancer Vaccine, Focuses on Infectious Diseases

Pictured: Syringe drawing from a series of vials/i Danish biotech Bavarian Nordic announced Wednesday it is discontinuing its immuno-oncology program and will focus its R&D efforts on infectious diseases. Pictured: Syringe drawing from a series of vials/iStock, NikiLitov Danish biotech Bavarian Nordic announced on Wednesday, as part of its preliminary 2023 financial results, that it would halt any future work on its cancer vaccine program. According to Bavarian Nordic, its cancer vaccine TAEK-VAC has reached a stage where more investments are required. The company would also have faced stiff competition in the cancer vaccine space as big names such as BioNTech, Merck and Moderna are making progress on their respective cancer vaccines. The TAEK-VAC program will stop with no plans to invest in an immune-oncology vaccine. The company’s website details the TAEK-VAC vaccine , which sought to use the body’s immune system to find and eliminate cancer cells. A Phase I trial of the vaccine was ongoing with the first stage of the study completed while stage two was open for enrollment. Bavarian Nordic said it will instead focus on infectious diseases through “product improvements” and new vaccine development to stay competitive. The company is working on a vaccine for the chikungunya virus and equine encephalitis, a rare mosquito-borne disease. For its chikungunya vaccine, Bavarian Nordic is currently conducting a Phase III trial. The results , which were posted in August 2023, showed that 98% of patients who took the vaccine had a strong induction of chikungunya-inducing antibodies. In addition, 97% of patients in the study had antibodies induced within two weeks of vaccination. Separately, an equine encephalitis vaccine has finished a Phase I trial and is being developed via a contract with the U.S. government. Bavarian Nordic disclosed that the development costs were DKK 850 million ($149 million) in 2023, with nearly half of those costs related to its chickungunya program. Bavarian Nordic’s preliminary 2023 results show the company secured revenue of over DKK 7 billion ($1 billion) compared to 3.1 billion ($449 million) in 2022. The biotech said that the spike in revenue was caused by a rise in sales of smallpox/mpox vaccines following an outbreak in 2022 and growth in the travel health business after an acquisition last year. Tyler Patchen is a staff writer at BioSpace . You can reach him at tyler.patchen@biospace.com . Follow him on LinkedIn .

Clinical ResultVaccinePhase 1Financial StatementPhase 3

21 Feb 2024

·www.biospace.com

Bavarian Nordic Puts Kibosh on Cancer Vaccine, Focuses on Infectious Diseases

Pictured: Syringe drawing from a series of vials/iStock, NikiLitov Danish biotech Bavarian Nordic announced on Wednesday, as part of its preliminary 2023 financial results, that it would halt any future work on its cancer vaccine program. According to Bavarian Nordic, its cancer vaccine TAEK-VAC has reached a stage where more investments are required. The company would also have faced stiff competition in the cancer vaccine space as big names such as BioNTech, Merck and Moderna are making progress on their respective cancer vaccines. The TAEK-VAC program will stop with no plans to invest in an immune-oncology vaccine. The company’s website details the TAEK-VAC vaccine, which sought to use the body’s immune system to find and eliminate cancer cells. A Phase I trial of the vaccine was ongoing with the first stage of the study completed while stage two was open for enrollment. Bavarian Nordic said it will instead focus on infectious diseases through “product improvements” and new vaccine development to stay competitive. The company is working on a vaccine for the chikungunya virus and equine encephalitis, a rare mosquito-borne disease. For its chikungunya vaccine, Bavarian Nordic is currently conducting a Phase III trial. The results, which were posted in August 2023, showed that 98% of patients who took the vaccine had a strong induction of chikungunya-inducing antibodies. In addition, 97% of patients in the study had antibodies induced within two weeks of vaccination. Separately, an equine encephalitis vaccine has finished a Phase I trial and is being developed via a contract with the U.S. government. Bavarian Nordic disclosed that the development costs were DKK 850 million ($149 million) in 2023, with nearly half of those costs related to its chickungunya program. Bavarian Nordic’s preliminary 2023 results show the company secured revenue of over DKK 7 billion ($1 billion) compared to 3.1 billion ($449 million) in 2022. The biotech said that the spike in revenue was caused by a rise in sales of smallpox/mpox vaccines following an outbreak in 2022 and growth in the travel health business after an acquisition last year. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

Phase 1VaccinePhase 3Financial StatementClinical Result

02 Feb 2023

·www.fiercebiotech.com

Merck admits defeat in race with Valneva to get first chikungunya vaccine to market

Merck confirmed to Fierce Biotech this morning that it has discontinued the chikungunya program, calling the decision part of a “routine pipeline prioritization.” Once neck and neck with Valneva to get the first chikungunya vaccine to market, it now looks like Merck & Co. has admitted defeat as its French rival reaches the finish line. Merck’s contender was V184, a vaccine acquired through the Big Pharma’s $366 million takeover of Themis in 2020. While the candidate completed a phase 2 trial, the study was suspended “due to a clinical stock recovery action” from December 2020 to the completion date in June 2021— meaning it never hit its original enrollment goal. Merck confirmed to Fierce Biotech this morning that it has now discontinued the chikungunya program as part of a “routine pipeline prioritization.” Perhaps the company had decided that second place wasn’t worth it. After all, while Merck’s vaccine ran into difficulties, Valneva’s raced through the clinic. Last December, the French company completed a rolling submission to the FDA for its single-shot candidate, dubbed VLA1553. Valneva’s application for approval in adults draws on phase 3 data demonstrating that VLA1553 induced a 96% protection rate after six months. The company also has an ongoing study in adolescents in Brazil, which Valneva said could support a future regulatory submission in this group. The sprint to approval was never just a two-horse race, however. Emergent BioSolutions is also fielding its own candidate, which is in two phase 3 trials. The biotech received an award from the U.S. Department of Defense last November to conduct further evaluations of the shot should it get approved. Chikungunya virus is spread to people by infected mosquitoes. Symptoms include fever, incapacitating joint pain, headache, muscle pain, joint swelling or rash. Like many tropical diseases, the reach of the virus is spreading into a wider range of countries.

Phase 3Phase 2Vaccine

100 Deals associated with Chikungunya virus vaccine(Themis Bioscience GmbH)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chikungunya Fever	Phase 2	Austria	Themis Bioscience GmbH	17 Aug 2016
Chikungunya Fever	Phase 2	Germany	Themis Bioscience GmbH	17 Aug 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03807843 (V184-006, CTgov)	Phase 2	Chikungunya Fever	41	V184 (V184)	ukthugjqpn(qvvvdsrxld) = hngjcwreor tezbukaszj (urodvhvdtx, honwdkgjke - mtwlibfveq) View more	-	16 May 2022
				Placebo (Placebo)	ukthugjqpn(qvvvdsrxld) = ivuuvcxdua tezbukaszj (urodvhvdtx, zvttwfpaxe - janeqdivsp) View more
NCT03635086 (V184-005, CTgov)	Phase 2	Chikungunya Fever	60	MV-CHIK lyophilised formulation, low dose (Group A: Two MV-CHIK Lyophilized Low Dose)	fptnhxvdgc(whuckdpqap) = dsmwljigjf ivdswitvsv (snyyeptdjs, psuzxtessm - pkpwymosfs) View more	-	20 Oct 2021
				MV-CHIK liquid frozen formulation, low dose (Group B: Two MV-CHIK Liquid Frozen Low Dose)	fptnhxvdgc(whuckdpqap) = wftdgejrep ivdswitvsv (snyyeptdjs, sahcaxufmh - xvnmzenrds) View more

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Chikungunya virus vaccine(Themis Bioscience GmbH)

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