RegulationPriority Review (United States), Breakthrough Therapy (United States), PRIME (European Union), Accelerated assessment (European Union), Fast Track (United States)

Structure/Sequence

Sequence Code 9535613

Sequence Code 10051604

Sequence Code 10051610

Clinical Trials associated with Chikungunya Vaccine, Recombinant (Bavarian Nordic)

NCT07467707

/ Not yet recruitingPhase 3

A Phase 3b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of an Adjuvanted Chikungunya Virus Virus-like Particle (CHIKV VLP) Vaccine for the Prevention of Chikungunya Disease in Adolescents (12 to <18 Years) and Adults (≥18 Years)

Study EBSI-CV-317-007 is a field study to evaluate the efficacy, immunogenicity, and safety of CHIKV VLP vaccine. The study was designed using infectious disease models and advanced analytics to guide region and clinical site prioritization, define the timing of study activities, and optimize the study parameters to local epidemiological conditions for CHIKV disease to overcome the challenges of assessing efficacy for CHIKV VLP vaccine.

Start Date01 May 2026

Sponsor / Collaborator

Bavarian Nordic A/S

[+4]

NCT07003984

/ RecruitingPhase 3

A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children 1 to <12 Years of Age

The goal of this multi-center, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity of CHIKV VLP Vaccine in children 1 to <12 years of age.

Start Date05 Jun 2025

Sponsor / Collaborator

Bavarian Nordic A/S

NCT06007183

/ Active, not recruitingPhase 3

A Long-term Follow-up Study to Evaluate Safety and Immunogenicity of a Chikungunya Virus Virus-like Particle Vaccine (PXVX0317) in Healthy Adults and Adolescents After Either a Single or Booster Vaccination Dosing Regimen

The purpose of this phase 3 multicenter, randomized, double-blind, placebo-controlled rollover study is to evaluate the safety and long-term immunogenicity of CHIKV VLP vaccine in adult and adolescent participants and to evaluate CHIKV VLP booster vaccine induced serum neutralizing antibody (SNA) response at 3, 4, or 5 years post-initial CHIKV VLP vaccination.

Start Date30 Aug 2023

Sponsor / Collaborator

Bavarian Nordic A/S

100 Clinical Results associated with Chikungunya Vaccine, Recombinant (Bavarian Nordic)

100 Translational Medicine associated with Chikungunya Vaccine, Recombinant (Bavarian Nordic)

100 Patents (Medical) associated with Chikungunya Vaccine, Recombinant (Bavarian Nordic)

134

Literatures (Medical) associated with Chikungunya Vaccine, Recombinant (Bavarian Nordic)

01 Apr 2026·ACTA TROPICA

New progress in the global expansion and prevention of chikungunya fever

Review

Author: Ye, Qing ; Zhang, Ting ; Shi, Ruoli ; Chen, Jiaxuan

Chikungunya fever, caused by the chikungunya virus, has emerged as a significant global public health threat, with sustained transmission reported in more than 100 countries. The disease presents with acute fever, rash, and severe polyarthralgia, while up to 40-60% of patients develop chronic arthritis-like sequelae. Climate change, globalization, and urbanization have facilitated the spread of Aedes aegypti and Aedes albopictus, driving recurrent outbreaks across Africa, the Indian Ocean, the Americas, Asia, and Europe, with recent large-scale transmission in China. In response, international and national public health agencies, have updated surveillance, clinical management, and vector-control guidelines. At the same time, vaccine development reached critical regulatory milestones in 2025: VIMKUNYA® (a virus-like particle vaccine) received regulatory approval in multiple regions, whereas IXCHIQ® (a live attenuated vaccine) faced post-marketing safety concerns leading to suspension in the United States in 2025, still licensed in some other regions, This review provides a comprehensive and up-to-date synthesis of advances in CHIKV virology, viral evolution and vector adaptation, global and China-focused epidemiology, clinical manifestations and chronic sequelae, laboratory diagnostics, therapeutic development, vaccines, and integrated prevention and control strategies. Special emphasis is placed on epidemiological trends, policy updates, and scientific developments reported during 2024-2025. Key research priorities include defining immune correlates of long-term protection, elucidating the mechanisms underlying chronic inflammatory arthritis, improving multiplex diagnostic platforms in co-endemic regions, and optimizing safe, durable, and population-specific vaccination strategies.

01 Mar 2026·VACCINE

Vaccination against chikungunya - a systematic review on the immunogenicity, tolerability, and safety of the live-attenuated vaccine (LAV) Ixchiq and the virus like particle (VLP) vaccine Vimkunya

Review

Author: Grünewald, Thomas ; Schönfeld, Christian ; Branke, Lisa ; Kling, Kerstin ; Ramharter, Michael ; Falman, Annika ; Rothe, Camilla

BACKGROUND:

Infections with the chikungunya virus are increasingly reported due to many reasons including climate change. Two vaccines against chikungunya have recently been approved in Europe, the live-attenuated vaccine (LAV) Ixchiq and the virus like particle (VLP) vaccine Vimkunya. However, no systematic review of phase 3 clinical trial data has been published that summarizes the currently available evidence on the immunogenicity, tolerability, and safety of these vaccines. Therefore, these data were systematically analyzed by a working group of the German Standing Committee on Vaccination (STIKO) and the German Society for Tropical Medicine, Travel Medicine and Global Health (DTG).

METHODS:

We conducted a systematic review of the immunogenicity, tolerability and safety of Ixchiq and Vimkunya using Embase and PubMed (OVID) according to predefined PICO criteria, including placebo-controlled randomized control trials, cohort, and case-control studies. Risk of bias (RoB) was assessed with the RoB 2-tool. Additionally, post-marketing safety data were studied.

RESULTS:

Clinical efficacy data were not available. Instead, seropositivity rates above a predefined threshold served as a surrogate of protection. Both vaccines demonstrated strong immunogenicity with seroprotection rates for Ixchiq of >98% after 4 weeks, and for Vimkunya after 3 weeks of >97% in 12-59-year-olds and > 87% in ≥65-year-olds. In the pivotal studies, both vaccines showed also an acceptable safety profile. Post-marketing safety data showed a higher risk for serious adverse events in elderly patients for Ixchiq.

CONCLUSION:

In addition to mosquito protection and vector control, two vaccines with a good efficacy profile based on the surrogate marker of seroprotection are now available to prevent chikungunya. While both vaccines showed acceptable tolerability, the safety of vaccines must be continuously assessed based on further data from post-marketing surveillance of the respective populations.

01 Feb 2026·Current Opinion in Virology

A storm is born: immune activation and pathogenesis in arthritogenic alphavirus infections

Review

Author: Koo, Yong Qian ; Freppel, Wesley ; Herrero, Lara J

Arthritogenic alphaviruses, including chikungunya (CHIKV), Ross River, and Mayaro viruses, are emerging global viruses responsible for causing arthralgia and chronic arthritis. Following mosquito-borne transmission, they quickly initiate infection in the skin, including in resident immune cells, and disseminate systemically into musculoskeletal tissues. The innate immune system responds rapidly through the activation of interferons, the production of inflammatory cytokines, and the recruitment of monocytes, macrophages, neutrophils, and dendritic cells, while the adaptive immune response, particularly virus-specific T and B cells, is critical for viral clearance. However, excessive immune activation can lead to both acute and chronic musculoskeletal pain through cytokine storm, tissue damage, and supporting immunopathology. Additionally, viral persistence and immune evasion may contribute to the development of chronic synovitis and cartilage degradation, leading to persistent joint pain. Despite recent advances, antiviral treatments remain unavailable, and to date, there is only one vaccine licensed (VIMKUNYA™ in 2025, against CHIKV), underscoring the urgent need for further research. This review explores the complex interplay between host immune responses and viral factors that lead from acute infection to chronic inflammation. Furthermore, it highlights key gaps in understanding viral persistence and immune evasion, and how to predict chronic diseases to improve therapeutic and preventive strategies against arthritogenic alphaviruses.

News (Medical) associated with Chikungunya Vaccine, Recombinant (Bavarian Nordic)

16 Apr 2026

·www.biospace.com

Bavarian Nordic Receives Swissmedic Approval for Chikungunya Vaccine

COPENHAGEN, Denmark, April 16, 2026 – Bavarian Nordic A/S (OMX: BAVA) today announced that the Swiss Agency for Therapeutic Products, Swissmedic, has approved VIMKUNYA ® (recombinant, adsorbed) for active immunization for the prevention of disease caused by chikungunya virus in individuals aged 12 years and above. The virus-like particle (VLP) single-dose vaccine is the first chikungunya vaccine to receive approval in Switzerland and was approved following review of the regulatory dossier submitted in July 2025, upon the FDA and EMA approvals of the vaccine earlier in 2025. “The Swiss approval marks another important milestone in our endeavors to bring protection against chikungunya to more people and reinforces our commitment to expanding access to our vaccine globally,” said Paul Chaplin, President & CEO of Bavarian Nordic . The approval of VIMKUNYA in Switzerland marks the fourth approval of Bavarian Nordic’s chikungunya vaccine, which was approved by the U.S. Food and Drug Administration (FDA), the European Commission and the UK Medicines and Healthcare products Regulatory Agency (MHRA) in 2025. Bavarian Nordic has also submitted an application to Health Canada, potentially supporting approval of the chikungunya vaccine in the first half of 2026. About VIMKUNYA ® Chikungunya vaccine (recombinant, adsorbed) VIMKUNYA is a single dose, prefilled, adjuvanted VLP recombinant protein vaccine for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older. It is designed to induce a robust seroresponse, with protective immunity starting to develop as early as 1 week after vaccination. The vaccine does not contain viral genetic material and is therefore non-infectious and unable to cause disease, ensuring a broad range of people can benefit from vaccination. About chikungunya Chikungunya is a mosquito-borne disease caused by the chikungunya virus. In the past 20 years, the virus has emerged across several regions in Asia, Africa, and the Americas, including many popular travel destinations, often causing large unpredictable outbreaks. Since its discovery, chikungunya has been identified in more than 110 countries 1 . Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover, but 30-40% of those affected may develop chronic symptoms that can last for months or even years 2 . In 2025, more than 500,000 cases of chikungunya and nearly 200 associated deaths were reported worldwide 3 . In Europe, more than 1,000 cases of local transmission were reported in 2025 from outbreaks in France and Italy 4 . Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile 5 . About Bavarian Nordic Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit . Contact investors: Europe: Disa Tuominen, IR Manager, detu@bavarian-nordic.com US: Graham Morrell, Gilmartin Group, graham@gilmartinir.com , Tel: +1 781 686 9600 Contact media: Nicole Seroff, Vice President Corporate Affairs, nise@bavarian-nordic.com , Tel: +45 53 88 06 03 1 World Health Organization (WHO). Chikungunya. 2 European Centre for Disease Prevention and Control. Chikungunya virus disease . . 3 World Health Organization (WHO). WHO Rapid Risk Assessment - Chikungunya virus disease, Global v.1 . . 4 European Centre for Disease Prevention and Control . Seasonal surveillance of chikungunya virus disease in the EU/EEA, weekly report . 5 Ribas Freitas AR, Pinheiro Chagas AA, Siqueira AM, Pamplona de Góes Cavalcanti L. How much of the current serious arbovirus epidemic in Brazil is dengue and how much is chikungunya? Lancet Reg Health Am. 2024 Apr 30;34:100753. doi: 10.1016/j.lana.2024.100753. PMID: 38711542; PMCID: PMC11070701. Attachment Bavarian Nordic Receives Swissmedic Approval for Chikungunya Vaccine

Drug ApprovalVaccine

25 Mar 2026

·frederick.cancer.gov

Vaccine set for wider use against mosquito-borne chikungunya

Image The "ankle biter" Aedes aegypti, which feeds in the daytime, often carries chikungunya and other viruses, such as zika, dengue, and yellow fever. An FDA-approved chikungunya vaccine manufactured by the Frederick National Laboratory and tested in early clinical trials a decade ago may become a bigger player in global health following a series of adverse event reports linked to the only other available vaccine for the mosquito-borne disease. The vaccine, Vimkunya, received FDA approval in 2025. The name chikungunya comes from the language of the Makonde people of southeast Tanzania and northern Mozambique. It means “that which bends” for the stooped posture of patients suffering joint pain from the infection. The virus also causes high fever, fatigue, and other symptoms that can become chronic. Severe and occasionally fatal cases can occur in infants, the elderly, and people with pre-existing conditions. In 2014, an investigational vaccine designed by the National Institute of Allergy and Infectious Diseases and manufactured by Frederick National Laboratory’s Vaccine Clinical Materials Program performed well in a phase I clinical trial, prompting a phase II collaboration between the National Institute of Allergy and Infectious Diseases and the Frederick laboratory’s Vaccine Clinical Materials Program and Clinical Monitoring Research Program directorates. The first and only other FDA-approved chikungunya vaccine, Ixchiq, has been more widely available, having been approved two years earlier than Vimkunya. But on August 22, 2025, the FDA suspended Ixchiq’s license, citing 21 hospitalizations and three deaths linked to its use. The FDA action has focused new attention on Vimkunya for potential use against chikungunya in endemic regions and during outbreaks of infection. “A vaccine first tested in small early-phase studies now steps in to the world ready to blunt chikungunya’s reach,” said David Lindsay, director of the Vaccine Clinical Materials Program. “This accomplishment was shaped by years of scientific inquiry, patient trust, and commitment to public health.” The vaccine’s phase I trial was conducted at the National Institutes of Health Clinical Center in Bethesda with 25 participants. For phase II, the Frederick laboratory’s Clinical Monitoring Research Program stepped in to help manage the international study with 400 participants in the Americas and Caribbean region, including Haiti, the Dominican Republic, Guadeloupe, Martinique, and Puerto Rico. The team provided program and subcontractor management, and staff traveled to conduct site feasibility assessments and study initiation visits. Theresa Engel, operations director for the Clinical Monitoring Research Program said the team procured study supplies and managed logistics for shipping supplies internationally. Last year, the World Health Organization reported a resurgence of chikungunya virus disease, with some countries experiencing substantial increases while others saw a decline. WHO counted more than 445,000 suspected and confirmed cases of chikungunya and 155 deaths in 40 countries around the world. Since 2014, chikungunya has also been reported in the Americas, with local transmission in Florida, Texas, Puerto Rico, and the U.S. Virgin Islands. Mary Ellen Hackett Manager, Communications Office 301-401-8670

Phase 2VaccineDrug ApprovalClinical ResultPhase 1

16 Mar 2026

·www.pharmaceutical-technology.com

Bavarian Nordic and SII sign agreement for chikungunya vaccine production

Bavarian Nordic has signed a manufacturing agreement with Serum Institute of India (SII), expanding its strategic partnership through a contract for its chikungunya vaccine (CHIKV VLP). The contract covers a full technology transfer for the vaccine manufacturing process from Bavarian Nordic to SII, aiming to increase production capacity and future supply for endemic low- and middle-income countries. The new arrangement builds upon the existing licence and manufacturing partnership between the two companies for the mpox vaccine. It replaces an earlier deal with Biological E. Both parties will also explore potential co-development opportunities as part of this extended collaboration. Bavarian Nordic’s president and CEO Paul Chaplin said: “We are pleased to strengthen our strategic partnership with Serum Institute of India. “By leveraging the strengths of both organisations, we can scale manufacturing of our chikungunya vaccine to expand global supply and improve access for populations around the globe.” The CHIKV VLP vaccine is a prefilled, single-dose, adjuvanted virus-like particle recombinant protein product intended for active immunisation against disease caused by the chikungunya virus in people aged 12 years and above. It is designed to trigger a strong seroresponse, with protective immunity beginning to develop as soon as one week following vaccination. As it does not contain viral genetic material, the vaccine is non-infectious and cannot cause disease, making it suitable for a broad population demographic. Marketed as Vimkunya, CHIKV VLP has received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the European Commission, and the US Food and Drug Administration (FDA) in 2025. Regulatory review is underway in Canada and Switzerland. In September 2025, Bavarian Nordic launched its chikungunya vaccine, Vimkunya, in the UK. The launch followed a significant increase in travel-related disease cases reported nationwide. The UK Health Security Agency (UKHSA) stated that incidences rose by 170% in August 2025 compared with the same period in 2024. The content above comes from the network. if any infringement, please contact us to modify.

VaccineDrug ApprovalLicense out/in

100 Deals associated with Chikungunya Vaccine, Recombinant (Bavarian Nordic)

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Chikungunya Fever	United States	Bavarian Nordic A/S	14 Feb 2025

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACR2025	Phase 2/3	Chikungunya Fever	3,141	CHIKV VLP vaccine	eoojtbimod(ayhcgsilov) = efzqhpxxhe baobsboanu (sbxczevtdc ) View more	Positive	24 Oct 2025
				Placebo	jsuxrznicv(mdkvgxkory) = keakgpqkwj anyveemewd (yqtycurnsv )
NCT03992872 (Pubmed \| Lancet Microbe)	Phase 2	Alphavirus Infections	60	Previous alphavirus vaccine recipients	ksupkmlkdk(vfwghdqejh) = There was no statistically significant difference in the incidence of solicited adverse events between the previous alphavirus vaccine recipients and alphavirus vaccine-naive controls (53.3% vs 40.0%, respectively), although the relatively small sample size of the trial limited the power to detect a significant difference, and there were no reported vaccine-related serious adverse events nwirkdhfan (stezmqrejn )	Positive	01 Apr 2025
				Alphavirus vaccine-naive controls
NCT05349617 (FDA_CBER) Manual	Phase 3	Chikungunya Fever	-	VIMKUNYA	anoaihlziq(vlppbhdxuz) = uekndnttdh tdnmktdjbc (pkirbvvtpb, 582.3 - 892.7) View more	Positive	14 Feb 2025
				Placebo	anoaihlziq(vlppbhdxuz) = eqmvbhrouz tdnmktdjbc (pkirbvvtpb, 6.5 - 10.0) View more
NCT05072080 (FDA_CBER) Manual	Phase 3	Chikungunya Fever	-	VIMKUNYA	zrfrwlbiac(rqvucxvggw) = gwdlizqnzr qzcebtlnkt (fovlobimpd, 1504.1 - 1695.6) View more	Positive	14 Feb 2025
				Placebo	zrfrwlbiac(rqvucxvggw) = nugvpfepne qzcebtlnkt (fovlobimpd, 7.0 - 8.8) View more
NCT05349617 (CTgov)	Phase 3	-	413	CHIKV VLP/adjuvant (Group 1 - PXVX0317)	unaxofxprk = zaxjvsohpb gkksexwxcg (eycynrizyw, txpzakvcbz - lcorhdsjxo) View more	-	13 Dec 2024
				Placebo (Group 2 - Placebo)	unaxofxprk = juahgeiady gkksexwxcg (eycynrizyw, zugdwzdjem - ixynfpsduz) View more
NCT05072080 (CTgov)	Phase 3	Chikungunya Fever	3,258	CHIKV VLP/adjuvant (Group 1)	iwnaiqxflt = rklugwpyrp zxpgusofha (twvuftfpsa, zbpqkypfqp - hbsrarskae) View more	-	30 Aug 2024
				CHIKV VLP/adjuvant (Group 2)	iwnaiqxflt = gsamqimzyo zxpgusofha (twvuftfpsa, qoizcudxoe - efsuvckcer) View more
NCT02562482 (phase 2, Pubmed \| Vaccine)	Phase 2	Chikungunya Fever focus reduction neutralizing antibody	400	CHIKV VLP vaccine seropositive recipients	xoofnmujqv(ktnuiwsddm) = ychsvtdvxg cbugwtfehs (yjhkoqstzm )	Positive	01 Oct 2023
				CHIKV VLP vaccine seronegative recipients	xoofnmujqv(ktnuiwsddm) = krynbcclaw cbugwtfehs (yjhkoqstzm )
NCT05065983 (CHIKV VLP, CTgov)	Phase 2	Chikungunya Fever	25	CHIKV VLP, adjuvanted	cobssnmlft = ymxmyvxwnn qixybrljni (lluvbfceaj, apnruyxmmh - qxvxpdzxas) View more	-	28 Feb 2023
NCT03992872 (WRAIR, Biospace) Manual	Phase 2	Alphavirus Infections \| Chikungunya Fever	60	PXVX 0317	qhojlhdqcr(rqlewjslpn) = The study demonstrated that the CHIKV VLP vaccine candidate was well-tolerated and immunogenic in both alphavirus vaccine-naïve participants and participants previously vaccinated against the Venezuelan equine encephalitis virus. laltlwgcdj (rstkijukxj )	Positive	01 Nov 2022
NCT02562482 (Pubmed \| J Coll Physicians Surg Pak) Manual	Phase 2	Chikungunya Fever	400	PXVX-0317	qkfjcmfjpr(nafzybveji) = zpxburtjzq qcaewxqgdt (toptipxkzo ) View more	Positive	14 Apr 2020
				Placebo	qkfjcmfjpr(nafzybveji) = ndhmixdzmf qcaewxqgdt (toptipxkzo ) View more

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Chikungunya Vaccine, Recombinant (Bavarian Nordic)

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