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)

29 Feb 2024·The Journal of general virology

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

Review

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

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 Nov 2019·VaccineQ3 · MEDICINE

Defining a correlate of protection for chikungunya virus vaccines

Q3 · MEDICINE

Review

Author: McAuley, Alexander J ; Milligan, Gregg N ; Beasley, David W C ; Schnierle, Barbara S

Chikungunya virus infection causes a debilitating febrile illness that in many affected individuals is associated with long-term sequelae that can persist for months or years. Over the past decade a large number of candidate vaccines have been developed, several of which have now entered clinical trials. The rapid and sporadic nature of chikungunya outbreaks poses challenges for planning of large clinical efficacy trials suggesting that licensure of chikungunya vaccines may utilize non-traditional approval pathways based on identification of immunological endpoint(s) predictive of clinical benefit. This report reviews the current status of nonclinical and clinical testing and potential challenges for defining a suitable surrogate or correlate of protection.

01 Jan 2019·Current Topics in Microbiology and ImmunologyQ3 · MEDICINE

Chikungunya Virus Vaccines: Platforms, Progress, and Challenges

Q3 · MEDICINE

Review

Author: DeFilippis, Victor R

Chikungunya is a clinically and economically important arbovirus that has spread globally in the twenty-first century. While uncommonly fatal, infection with the virus can lead to incapacitating arthralgia that can persist for months to years. The adverse impacts of viral spread are most severe in developing low- and middle-income countries in which medical infrastructure is insufficient and manual labor is an economic driver. Unfortunately, no prophylactic or therapeutic treatments are approved for human use to combat the virus. Historically, vaccination has proven to be the most efficient and successful strategy for protecting populations and eradicating infectious disease. A large and diverse range of promising vaccination approaches for use against Chikungunya has emerged in recent years and been shown to safely elicit protective immune responses in animal models and humans. Importantly, many of these are based on technologies that have been clinically approved for use against other pathogens. Furthermore, clinical trials are currently ongoing for a subset of these. The purpose of this review is to provide a description of the relevant immunobiology of Chikungunya infection, to present immune-stimulating technologies that have been successfully employed to protect against infection, and discuss priorities and challenges regarding the future development of a vaccine for clinical use.

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

Clinical Result

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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)	mlykvhento = hjldceggcs pmtgraoemb (hbuubhqmtn, gbuaiwwfcy - rswnixulmb) View more	-	16 May 2022
				Placebo (Placebo)	mlykvhento = bmqrqnsfff pmtgraoemb (hbuubhqmtn, zceejlzpdh - kbnyknbdcf) 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)	ymsnphcozs(aotundxhib) = mxhvlqnsgi oairfuezwn (shvqykvlhp, gtbksjtbdk - maigpiehef) View more	-	20 Oct 2021
				MV-CHIK liquid frozen formulation, low dose (Group B: Two MV-CHIK Liquid Frozen Low Dose)	ymsnphcozs(aotundxhib) = mcrifawzmo oairfuezwn (shvqykvlhp, ndivxhpwza - cebwthguha) View more
NCT03101111 (CTgov)	Phase 2	Chikungunya Fever	34	MV-CHIK-Placebo (MV-CHIK-Placebo/Seropositive)	eyaqhsjcoi = hqaeifkqxv ejkadioraj (hnodpgfsld, yibscfkksd - olicnkbmmj) View more	-	19 Jul 2021
				Placebo+MV-CHIK (MV-CHIK-Placebo/Seronegative)	eyaqhsjcoi = pkregihewa ejkadioraj (hnodpgfsld, piryvoodak - rwwxrqvfco) View more

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