RegulationFast Track (United States), PRIME (European Union), Accelerated assessment (European Union), Priority Review (United States), Breakthrough Therapy (United States)

Structure/Sequence

Sequence Code 9535613

Sequence Code 10051604

Sequence Code 10051610

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

NCT07003984

/ RecruitingPhase 3

A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children 2 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 2 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

NCT05349617

/ CompletedPhase 3

A Phase 3 Safety and Immunogenicity Trial of the VLP-Based Chikungunya Virus Vaccine PXVX0317 in Adults ≥65 Years of Age

The purpose of this phase 3, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity to PXVX0317 in adults ≥65 years of age.

Start Date12 May 2022

Sponsor / Collaborator

Bavarian Nordic A/S

[+1]

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)

119

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

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.

31 Dec 2025·Expert Review of Vaccines

Virus-like particles: a versatile and effective vaccine platform

Review

Author: Bachmann, Martin F. ; Lienert, Florian ; van Damme, Pierre ; Schwarz, Tino F.

INTRODUCTION:

Traditional live-attenuated or inactivated vaccines have limitations, including risks associated with uncontrolled replication, reduced immunogenicity, or production complexities. To address these issues, alternative platforms such as virus-like particles (VLPs) have been developed.

AREAS COVERED:

VLPs are self-assembling structures composed of viral proteins that mimic native viruses but are noninfectious. This review provides an overview of their structure, design and manufacture that make them an attractive platform for vaccine development. We then discuss the clinical development of some recently approved VLP vaccines and those widely used in immunization programs, summarizing the clinical trial data that underpins their efficacy and safety profiles. Additionally, we explore VLP vaccines in late-stage clinical development for respiratory syncytial virus and human metapneumovirus.

EXPERT OPINION:

VLPs are a versatile and promising platform for vaccine development. Their ability to mimic native viruses while eliminating the risks associated with live vaccines positions them as an attractive platform for vaccine design. Currently approved VLP vaccines demonstrate that they can provide effective protection against a wide range of diseases. Advances in VLP design and production are likely to lead to highly effective vaccines, significantly contributing to global immunization efforts.

17 Dec 2025·JOURNAL OF TRAVEL MEDICINE

Chikungunya vaccination for travellers: practical guidance for clinical decision-making

Review

Author: Staples, J Erin ; Chen, Lin H ; Schofield, Steven ; Shlim, David R ; Wilson, Mary E ; Hills, Susan L ; Christensen, Kristin J ; Barnett, Elizabeth D

Abstract:

Background:

Two vaccines have been licensed to prevent chikungunya, a live attenuated vaccine (IXCHIQ) manufactured by Valneva and a virus-like particle chikungunya vaccine (VIMKUNYA) manufactured by Bavarian Nordic. One or both vaccines are now available in many countries globally, including Brazil, Canada, United Kingdom, United States and some European countries and territories.

Key findings:

While the absence of a head-to-head study limits comparative inferences, the two vaccines have several different characteristics that should be considered when advising individual travellers. We outline key information on the vaccines including immunogenicity and safety data, recommendations for use in travellers and guidance for use in pregnancy and breastfeeding.

Conclusion:

Knowledge of the profiles and key features of the live attenuated and virus-like particle vaccines will enable healthcare providers to better advise travellers who are considering chikungunya vaccination.

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

23 Jan 2026

·www.globenewswire.com

Bavarian Nordic Signs Distribution Agreement with Eurofarma to Expand Access to Chikungunya Vaccine in Brazil

Agreement to enable the first entry in Latin America for Bavarian Nordic’s chikungunya vaccinePotential to expand agreement to cover rest of Latin America COPENHAGEN, Denmark, January 23, 2026 – Bavarian Nordic A/S (OMX: BAVA) today announced an agreement with Eurofarma, granting them exclusive rights to sell and distribute Bavarian Nordic’s chikungunya vaccine, CHIKV VLP, in Brazil. Eurofarma is also granted the right of first refusal for any future opportunity to register and commercialize the chikungunya vaccine in the rest of Latin America. The agreement is transfer price and royalty-based with no associated upfront or milestone payments. Eurofarma will be responsible for seeking and maintaining regulatory approval of the vaccine in exclusive territories, as well as sales and distribution costs. Bavarian Nordic will remain the manufacturer of the vaccine, which is made available to Eurofarma through a transfer price agreement. Pending discussions with the Brazilian Health Regulatory Agency, Anvisa, regulatory submission is expected to occur later in the first half of 2026, potentially supporting launch of the chikungunya vaccine in Brazil in the second half of 2027. “Following a successful launch of our chikungunya vaccine for travelers in the first Western markets in 2025, we are pleased to expand the commercial availability also for endemic populations through this first distribution agreement,” said Paul Chaplin, President & CEO of Bavarian Nordic. “Brazil remains severely impacted by chikungunya, representing half of all reported cases and related deaths worldwide. Together with Eurofarma, a local partner with strong regional presence, we continue our efforts to make a lasting impact on public health globally.” “Our partnership with Bavarian Nordic reinforces Eurofarma’s commitment to innovation and to expanding access to high‑quality healthcare. It builds on our strong capabilities to deliver high‑impact solutions for people in Brazil and across Latin America—so that everyone has the opportunity to live longer and better,” says João Siffert, Eurofarma’s Vice President of Innovation. While the agreement aims to significantly improve access to chikungunya vaccines in Brazil, it is not expected to have a material short- to medium-term financial impact on Bavarian Nordic. // About CHIKV VLPCHIKV VLP 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. The vaccine was approved by the U.S. Food and Drug Administration (FDA) and the European Commission in February 2025 and the United Kingdom in May 2025 under the trade name VIMKUNYA®1. About chikungunyaChikungunya 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 countries2. 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 years3. In 2025, as of December, nearly 500,000 cases of chikungunya and over 200 associated deaths were reported worldwide4. More than half of the reported cases and associated deaths were reported from Brazil5. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile6. About Bavarian NordicBavarian 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 www.bavarian-nordic.com. About EurofarmaFounded in 1972, Eurofarma covers key pharmaceutical segments and is the leader in medical prescriptions in Brazil. A Brazilian multinational company operating in 24 countries, with full coverage across Latin America and retail leadership in the region, the company also maintains operations in the United States and Africa, with more than 13,500 employees and 11 manufacturing facilities. In 2024, Eurofarma produced 600 million units. That same year, the company invested over USD 122 million in innovation projects and achieved net revenue exceeding USD 1.78 billion. For more information: www.eurofarma.com.br Contact investors:Europe: Disa Tuominen, IR Manager, detu@bavarian-nordic.comUS: Graham Morrell, Gilmartin Group, graham@gilmartinir.com, Tel: +1 781 686 9600 Contact media:Nicole Seroff, Vice President Corporate Communications, nise@bavarian-nordic.com, Tel: +45 53 88 06 03 1 Marketed as VIMKUNYA™ in the US. Marketed as VIMKUNYA® in EU and the United Kingdom. 2 World Health Organization (WHO). Chikungunya.https://www-who-int.libproxy1.nus.edu.sg/news-room/fact-sheets/detail/chikungunya 3 European Centre for Disease Prevention and Control. Chikungunya virus disease. https://www.ecdc.europa.eu/en/chikungunya-virus-disease. 4 European Centre for Disease Prevention and Control. Chikungunya virus disease worldwide overview. https://www.ecdc.europa.eu/en/chikungunya-monthly. 5 Pan American Health Organization (PAHO). Chikungunya: analysis by country. https://www.paho.org/en/arbo-portal/chikungunya-data-and-analysis/chikungunya-analysis-country 6 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 Signs Distribution Agreement with Eurofarma to Expand Access to Chikungunya Vaccine in Brazil

VaccineDrug Approval

20 Jan 2026

·www.fiercepharma.com

Valneva withdraws chikungunya vaccine Ixchiq from US amid new FDA investigation

Valneva's withdrawal of Ixchiq leaves Bavarian Nordic’s Vimkunya the only available chikungunya vaccine in the U.S. Following an FDA marketing suspension, Valneva has decided to voluntarily withdraw its chikungunya vaccine Ixchiq in the U.S.The French company announced the decision Monday, noting that the FDA has also opened an investigation into a newly reported serious adverse event.The FDA suspended Ixchiq’s approval in August after raising serious safety concerns related to the vaccine. At that time, the agency said it had received reports of one death from encephalitis “directly attributable” to the vaccine and more than 20 serious adverse events—hospitalizations and deaths—that were “consistent with chikungunya-like illness.”According to Valneva, the agency recently placed a clinical hold on Ixchiq’s development program to investigate a new case reported outside the U.S. The event involved a younger adult who received three vaccines together, including Ixchiq. Valneva described the case as “plausibly related to Ixchiq vaccination" but caveated that "causality has not been determined.”With an FDA accelerated approval in November 2023, Ixchiq became the world’s first shot for chikungunya. Its retreat leaves Bavarian Nordic’s Vimkunya the only available chikungunya vaccine in the U.S. To confirm Ixchiq’s efficacy and safety profile, Valneva has planned to start a post-marketing phase 4 program, including a randomized controlled efficacy and safety study for adults in endemic countries and an observational effectiveness study in Brazil. In its Jan. 19 release, the company said it “intends to move forward” with the post-marketing activities “subject to further discussions with relevant regulatory authorities.”With the withdrawal, it appears that Valneva does not wish to bring Ixchiq back to the U.S., even upon completing the post-marketing study.“This is a permanent decision,” a Valneva spokesperson told Fierce Pharma.“The withdrawal of our Ixchiq BLA in the U.S. does not have any impact on Valneva’s workforce,” the spokesperson added.As the vaccine was in its early launch phase and had been suspended since August, Valneva didn’t factor any U.S. Ixchiq sales into its projections for 2025 and beyond.Despite the safety issues and U.S. withdrawal, Valneva said it continues to engage with other health regulators in Europe, Canada, the U.K. and Brazil, where Ixchiq is licensed. While the vaccine’s various marketing authorizations target travelers, Valneva argues that “Ixchiq’s benefit-risk profile also remains favorable for people living in the endemic and outbreak settings.” RELATED Vaccine-focused Valneva consolidates R&D footprint by shuttering site, eliminating 30 rolesMeanwhile, Valneva investors’ focus remains on a potentially imminent phase 3 readout from VLA15, a Lyme disease vaccine partnered with Pfizer. There are about 476,000 annual cases of Lyme disease in the U.S. and 87 million people living in endemic regions in the country, with no vaccine currently available, according to Valneva.VLA15 uses a primary series of three doses, followed by a booster dose before the second tick season. That’s different from the two-plus-one regimens by LYMErix and ImuLyme, both of which were withdrawn from the market in the early 2000s amid poor market performance. VLA15’s efficacy will be evaluated after that second season in the phase 3 trial.

Phase 3VaccineDrug ApprovalAccelerated Approval

02 Dec 2025

·www.fiercepharma.com

House endorses bill that would revive FDA's rare pediatric review voucher program

A bill sponsored by Rep. Michael McCaul, R-Texas, which would restore the FDA's rare pediatric review voucher program, which expired in December of last year, has passed the House of Representatives. The U.S. House of Representatives has given a unanimous thumbs-up to the Give Kids A Chance Act, which would revive the FDA’s rare pediatric review voucher program following its expiration in December of last year.Rep. Michael McCaul, R-Texas, introduced the legislation in February alongside support from five other Republican Congressmen and five Democrats. The bill now advances to a Senate vote.“By strengthening incentives for pediatric drug development, restoring essential programs such as the FDA Rare Pediatric Disease Priority Review Voucher, and ensuring that life-saving therapies reach the children who need them most, we are making meaningful progress,” Rep. Gus Bilirakis, R-Fla., said in a release.The initiative, which was established in 2012, offered drugmakers a financial incentive in the form of a priority review voucher (PRV) to develop rare disease treatments for children.PRVs are valued commodities in the biopharma industry because they can slash the FDA’s review time of drug applications from the standard 10 months to six months. In many cases, companies that were awarded PRVs for developing approved rare disease drugs sold them to other drugmakers anxious to bring a lucrative product to the market. As it previously appeared that the pediatric review voucher program was not going to gain Congressional reauthorization and the availability of PRVs grew scarce, their prices increased from a standard $100 million. In August of last year, Ipsen received $158 million from an unnamed buyer for a PRV it gained from the FDA upon approval of the rare disease drug Sohonos in August of 2023.Six months ago, an unnamed buyer paid Bavarian Nordic $160 million for a PRV awarded by the FDA under its tropical disease incentive program for the February approval of the chikungunya vaccine Vimkunya. In May, Abeona Therapeutics sold a PRV for $155 million that it had gained just two weeks earlier upon the approval of its gene therapy Zevaskyn.After the rare pediatric review program expired, there were calls from the industry to reestablish it, while critics raised concerns that the ability to sell PRVs at high prices distorted the program's original purpose. In an article published in February, lawyers at Hyman, Phelps & McNamara suggested the end of the rare pediatric PRV program could lead to increased value of the tropical disease PRVs, potentially to a level on par with a record $350 million that AbbVie paid United Therapeutics in 2015.Meanwhile, in June of this year, the FDA introduced a new PRV program designed to shorten drug review time to as little as one or two months. The commissioner’s National Priority Voucher (CNPV) coupon is given to “companies aligned with U.S. national priorities,” the FDA said. Unlike existing PRVs, CNPVs are nontransferable.

Priority Review

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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Evaluation

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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	lvrwdfwusm(agyimdwhkq) = acwbdyegqf wahxgtfzmo (gtfdejdqix ) View more	Positive	24 Oct 2025
				Placebo	qgrfpusiwb(fceixsjffy) = aihgwriwef ettppslybm (mpgxadpksc )
NCT03992872 (Pubmed \| Lancet Microbe)	Phase 2	Alphavirus Infections	60	Previous alphavirus vaccine recipients	dafmoajhtl(synylfyhlm) = 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 flgngquyqm (uwhnjxlwdd )	Positive	01 Apr 2025
				Alphavirus vaccine-naive controls
NCT05349617 (FDA_CBER) Manual	Phase 3	Chikungunya Fever	-	VIMKUNYA	vlwjcomrix(qwbseovkgo) = zthevblwym wxtnvsxxlz (wqhfsfcxiz, 582.3 - 892.7) View more	Positive	14 Feb 2025
				Placebo	vlwjcomrix(qwbseovkgo) = ngtaibrxfi wxtnvsxxlz (wqhfsfcxiz, 6.5 - 10.0) View more
NCT05072080 (FDA_CBER) Manual	Phase 3	Chikungunya Fever	-	VIMKUNYA	mzdgqcfrmn(hpvocyrtmk) = rpglcyhnfc ppdysasdmy (vzvaiwezfh, 1504.1 - 1695.6) View more	Positive	14 Feb 2025
				Placebo	mzdgqcfrmn(hpvocyrtmk) = slnnazptdh ppdysasdmy (vzvaiwezfh, 7.0 - 8.8) View more
NCT05349617 (CTgov)	Phase 3	-	413	CHIKV VLP/adjuvant (Group 1 - PXVX0317)	vdqzmormug = eegepeoyzi dlkqdvcvdb (eeknvokruw, aftlcndjrr - gjoasignzq) View more	-	13 Dec 2024
				Placebo (Group 2 - Placebo)	vdqzmormug = fqmxwqhxfw dlkqdvcvdb (eeknvokruw, rxddzowfqn - xvybqpuuuf) View more
NCT05072080 (CTgov)	Phase 3	Chikungunya Fever	3,258	CHIKV VLP/adjuvant (Group 1)	rbodruuhzk = yanukdbeoi rdcyyjpywn (gaedozqtmb, yxuamjbdmk - nhgqndwrvf) View more	-	30 Aug 2024
				CHIKV VLP/adjuvant (Group 2)	rbodruuhzk = xcelqyafyx rdcyyjpywn (gaedozqtmb, hglvxlvxfz - ssyguusmbu) View more
NCT02562482 (phase 2, Pubmed \| Vaccine)	Phase 2	Chikungunya Fever focus reduction neutralizing antibody	400	CHIKV VLP vaccine seropositive recipients	fclusuawtd(wfcktvjbgu) = mzhqkywadr xalgpibyie (haftucpdgd )	Positive	01 Oct 2023
				CHIKV VLP vaccine seronegative recipients	fclusuawtd(wfcktvjbgu) = qkhkcjrrot xalgpibyie (haftucpdgd )
NCT05065983 (CHIKV VLP, CTgov)	Phase 2	Chikungunya Fever	25	CHIKV VLP, adjuvanted	hmwqmdasbf = pfxvoxdajs exiodqootc (awloeifgxf, faxwjrvikc - kkzaibbptz) View more	-	28 Feb 2023
NCT03992872 (WRAIR, Biospace) Manual	Phase 2	Alphavirus Infections \| Chikungunya Fever	60	PXVX 0317	ccowefilxf(rettfxoxme) = 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. xztrbjxeqh (giqspddttg )	Positive	01 Nov 2022
NCT02562482 (Pubmed \| J Coll Physicians Surg Pak) Manual	Phase 2	Chikungunya Fever	400	PXVX-0317	qdlhlwgawp(nwtqxqcvam) = ondifjjghf uiinfdaxkn (iwukwvqwbt ) View more	Positive	14 Apr 2020
				Placebo	qdlhlwgawp(nwtqxqcvam) = kfteezizij uiinfdaxkn (iwukwvqwbt ) View more

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Chikungunya Vaccine, Recombinant (Bavarian Nordic)

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