A Phase 2 Open-label Study to Assess the Safety and Immunogenicity of an Alum-adjuvanted Chikungunya Virus-like Particle Vaccine (PXVX0317) in Prior Recipients of Other Alphavirus Vaccines Versus Alphavirus Naïve Controls.

This was a phase 2 parallel-group age- and gender-matched open label study in healthy adults 18-65 years of age to assess the safety and immunogenicity of an alum-adjuvanted chikungunya virus-like particle vaccine (PXVX0317; CHIKV VLP vaccine) in prior recipients of other alphavirus vaccines versus alphavirus naïve controls.

Start Date20 Nov 2019

Sponsor / Collaborator

Bavarian Nordic A/S

[+2]

NCT03483961 / CompletedPhase 2

A Phase 2 Parallel-Group, Randomized, Double-Blind Study to Assess the Safety and Immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV-VLP], Unadjuvanted or Alum-adjuvanted)

The goal of this Phase 2 trial is to evaluate the immune response to and safety profile of various doses/formulations/and schedules of administration of PXVX0317 in healthy adults.
Primary Objective:
To assess the immune response to the vaccine
Secondary Objectives:
To assess the kinetics of the immune response to different doses/formulations/schedules To assess the persistence of immune responses to different doses/formulations/schedules To assess the effect of a booster dose of the vaccine
Safety Objective:
To assess local and systemic reactions to the vaccine and to describe the safety profile of the vaccine

Start Date18 Apr 2018

Sponsor / Collaborator

Bavarian Nordic A/S

[+1]

NCT03028441 / CompletedPhase 1IIT

A Phase 1, Double Blinded, Placebo Controlled, Dose Comparison Trial to Evaluate the Safety, Immunogenicity and Schedule of Measles-Vectored Chikungunya Virus Vaccine (MV-CHIK) in Healthy Adults

This study is a randomized, double-blinded, Phase 1, placebo- controlled, and dose comparison trial to evaluate the safety, immunogenicity and schedule of MV-CHIK. Two dosage levels and 3 immunization schedules will be evaluated. This study will enroll up to 180 healthy subjects aged 18 to 45 years.Study duration is approximately 22 months. Subject participation duration is approximately 8-13 months. The primary objectives are to evaluate the safety and tolerability of 5 x 10^4 TCID50 and 5 x 10^5 TCID50 MV-CHIK and placebo following two consecutive intramuscular injections and to assess the CHIKV serum plaque reduction neutralization test (PRNT50) antibody responses to 5 x 10^4 TCID50, 5 x 10^5 TCID50 of MV-CHIK or placebo on day 29 following the first dose.

Start Date30 May 2017

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with PXVX-0317

100 Translational Medicine associated with PXVX-0317

100 Patents (Medical) associated with PXVX-0317

Literatures (Medical) associated with PXVX-0317

01 Feb 2025·Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy

Chemometrics and analytical blank on the at-line monitoring of Zika-VLP production using near-infrared spectroscopy

Article

Author: Leme, Jaci ; Oliveira Guardalini, Luis Giovani ; de Oliveira Guardalini, Luis Giovani ; Barros, Iago Henrique ; Rabello, Júlia Públio ; Calil Jorge, Soraia Attie ; Tejo Dias, Vinícius Aragão ; Tonso, Aldo ; Aragão Tejo Dias, Vinícius ; Nunes, Robson ; da Silva Cavalcante, Paulo Eduardo ; Fernández Núñez, Eutimio Gustavo ; Correia Barrence, Fernanda Angela ; Bernardino, Thaissa Consoni

The Zika disease caused by the Zika virus was declared a Public Health Emergency by the World Health Union (WHO), with microcephaly as the most critical consequence. Aiming to reduce the spread of the virus, biopharmaceutical organizations invest in vaccine research and production, based on multiple platforms. A crescent vaccine production approach is based on virus-like particles (VLP), for not having genetic material in its composition, hypoallergenic and non-mutant character. For bioprocess, it is essential to have means of real-time monitoring, which can be assessed using process analysis techniques such as Near-infrared (NIR) spectroscopy, that can be combined with chemometric methods, like Partial-Least Squares (PLS) and Artificial Neural Networks (ANN) for prediction of biochemical variables. This work proposes a biochemical Zika VLP upstream production at-line monitoring model using NIR spectroscopy comparing sampling conditions (with or without cells), analytical blank (air, ultrapure water), and spectra pre-processing approaches. Seven experiments in a benchtop bioreactor using recombinant baculovirus/Sf9 insect cell platform in serum-free medium were performed to obtain biochemical and spectral data for chemometrics modeling (PLS and ANN), composed by a random data split (80 % calibration, 20 % validation) for cross-validation of the PLS models and 70 % training, 15 % testing, 15 % validation for ANN. The best models generated in the present work presented an average absolute error of 1.59 × 10⁵ cell/mL for density of viable cells, 2.37 % for cell viability, 0.25 g/L for glucose, 0.007 g/L for lactate, 0.138 g/L for glutamine, 0.18 g/L for glutamate, 0,003 g/L for ammonium, and 0.014 g/L for potassium.

31 Dec 2024·Emerging Microbes & Infections

A nucleoside-modified mRNA vaccine forming rabies virus-like particle elicits strong cellular and humoral immune responses against rabies virus infection in mice

Article

Author: Wang, Yipeng ; Jiang, Chunlai ; Su, Weiheng ; Liu, Wenhao ; Liu, Jie ; Peng, Hanyu ; Zhang, Yong ; Wang, Zihan ; Ding, Xue ; Sun, Jie

Rabies is a lethal zoonotic disease that threatens human health. As the only viral surface protein, the rabies virus (RABV) glycoprotein (G) induces main neutralizing antibody (Nab) responses; however, Nab titre is closely correlated with the conformation of G. Virus-like particles (VLP) formed by the co-expression of RABV G and matrix protein (M) improve retention and antigen presentation, inducing broad, durable immune responses. RABV nucleoprotein (N) can elicit humoral and cellular immune responses. Hence, we developed a series of nucleoside-modified RABV mRNA vaccines encoding wild-type G, soluble trimeric RABV G formed by an artificial trimer motif (tG-MTQ), membrane-anchored prefusion-stabilized G (preG). Furthermore, we also developed RABV VLP mRNA vaccine co-expressing preG and M to generate VLPs, and VLP/N mRNA vaccine co-expressing preG, M, and N. The RABV mRNA vaccines induced higher humoral and cellular responses than inactivated rabies vaccine, and completely protected mice against intracerebral challenge. Additionally, the IgG and Nab titres in RABV preG, VLP and VLP/N mRNA groups were significantly higher than those in G and tG-MTQ groups. A single administration of VLP or VLP/N mRNA vaccines elicited protective Nab responses, the Nab titres were significantly higher than that in inactivated rabies vaccine group at day 7. Moreover, RABV VLP and VLP/N mRNA vaccines showed superior capacities to elicit potent germinal centre, long-lived plasma cell and memory B cell responses, which linked to high titre and durable Nab responses. In summary, our data demonstrated that RABV VLP and VLP/N mRNA vaccines could be promising candidates against rabies.

01 Dec 2024·Vaccine

Chikungunya vaccine development, challenges, and pathway toward public health impact

Review

Author: Khazhidinov, Kanat ; Santos, Gustavo Mendes Lima ; Sahastrabuddhe, Sushant ; Medina, Libia Milena Hernandez ; Abbas, Kaja ; Clemens, John ; Auzenbergs, Megan ; Maure, Clara ; Wartel, T Anh ; Moyersoen, Pascaline ; Kim, Jerome H ; Kang, Hyolim

Chikungunya is a neglected tropical disease of growing public health concern with outbreaks in more than 114 countries in Asia, Africa, Americas, Europe, and Oceania since 2004. There are no specific antiviral treatment options for chikungunya virus infection. This article describes the chikungunya vaccine pipeline and assesses the challenges in the path to licensure, access, and uptake of chikungunya vaccines in populations at risk. Ixchiq (VLA1533/Ixchiq - Valneva) was the first licensed chikungunya vaccine by the US Food and Drug Administration in November 2023, European Medicines Agency in May 2024, and Health Canada in June 2024. Five chikungunya vaccine candidates (BBV87 - BBIL/IVI, MV-CHIK - Themis Bioscience, ChAdOx1 Chik - University of Oxford, PXVX0317 / VRC-CHKVLP059-00-VP - Bavarian Nordic, and mRNA-1388 - Moderna) are in development. Evidence on chikungunya disease burden alongside the public health and economic impact of vaccination are critical for decision-making on chikungunya vaccine introduction in endemic and epidemic settings. Further, global and regional stakeholders need to agree on a sustainable financing mechanism for manufacturing at scale to facilitate fair access and equitable vaccine distribution to at-risk populations in different geographic settings. This could partly be facilitated through obtaining consensus on scientific and regulatory principles for initial vaccine introduction and generating evidence on chikungunya burden and disease awareness among populations at risk. Specifically, this article advocates for the formation of a global chikungunya vaccine consortium that includes regulators, policymakers, sponsors, and manufacturers to assist in overcoming the global and local challenges for chikungunya vaccine licensure, policy, financing, demand generation, and access to at-risk populations.

News (Medical) associated with PXVX-0317

13 Aug 2024

·www.globenewswire.com

Bavarian Nordic Announces FDA Acceptance and Priority Review of the BLA for its Chikungunya Vaccine

PDUFA target action date of February 14, 2025 COPENHAGEN, Denmark, August 13, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Biologics License Application (BLA) for CHIKV VLP, the Company’s vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older. The Priority Review designation means the FDA is targeting completion of its review within six months, compared to 10 months under standard review, and thus has assigned a Prescription Drug User Free Act (PDUFA) target action date of February 14, 2025. “We are encouraged by the FDA’s decision to grant Priority Review to our chikungunya vaccine, allowing for a shorter review time, and we look forward to working closely with the regulators to make our vaccine available to individuals 12 years of age and older at risk of chikungunya virus infection. The FDA review, along with the ongoing review of our CHIKV VLP vaccine by EMA, represent the first regulatory reviews of a chikungunya vaccine for adolescents, potentially providing a broader usage by populations at risk of this debilitating disease,” said Paul Chaplin, President and CEO of Bavarian Nordic. CHIKV VLP is currently also under accelerated assessment review with the European Medicines Agency (EMA), potentially supporting approval of the vaccine by the European Commission in the first half of 2025. About CHIKV VLP vaccineCHIKV VLP is an adjuvanted VLP-based vaccine candidate for active immunization to prevent disease caused by CHIKV infection. Pending regulatory approval, the single-dose vaccine will be made in a pre-filled syringe, designed to ease administration by saving vaccinators' time and reducing the risk of administrative errors. The CHIKV VLP vaccine candidate received Breakthrough Therapy designation and Fast Track designation from the FDA in October 2020 and April 2018, respectively, and PRIME designation from the EMA in September 2019. These designations are designed to facilitate the development or expedite review of medicines that either target an unmet medical need or may demonstrate substantial improvement over available therapy. In February 2024, the Committee for Medicinal Products for Human Use (CHMP) under EMA granted accelerated assessment for the MAA for the CHIKV VLP vaccine candidate based on the vaccine’s major interest for public health and therapeutic innovation. About chikungunyaChikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), which belongs to the group of arboviruses like dengue virus. CHIKV disease typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. While mortality is relatively low, morbidity is high; nearly 50% of individuals with CHIKV disease have debilitating long-term symptoms that can intensify with age. In the past 20 years, the CHIKV has emerged in several previously non-endemic regions in Asia, Africa, southern Europe, and the Americas, often causing large unpredictable outbreaks. Recent data1 suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to lack of proper testing. About Bavarian NordicBavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are a global leader in smallpox and mpox vaccines, supplied to governments to enhance public health preparedness and have a strong portfolio of vaccines for travelers and endemic diseases. For more information visit www.bavarian-nordic.com. Forward-looking statements This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. ContactsEurope: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-nordic.com, Tel: +45 61 77 47 43 US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600 Company Announcement no. 22 / 2024 1 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 2024-22-en

Priority ReviewVaccineBreakthrough TherapyFast TrackClinical Study

19 Jul 2024

·www.globenewswire.com

Bavarian Nordic Receives EMA Filing Acceptance and Validation of the MAA for its Chikungunya Vaccine

EMA will now initiate its centralized review procedure under accelerated assessment for Bavarian Nordic’s chikungunya vaccine July 18, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA), which was submitted in June 2024 for CHIKV VLP, the Company’s vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older. Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure under accelerated assessment. The accelerated assessment, which was granted by EMA’s Committee for Medicinal Products for Human Use (CHMP) in February 2024, aims to reduce the timeframe for the CHMP to review a MAA, potentially supporting approval of the vaccine by the European Commission in the first half of 2025. “The MAA submission and review marks a pivotal milestone for Bavarian Nordic in 2024, and we look forward to working closely with EMA throughout the evaluation process to make our chikungunya vaccine available to individuals 12 years of age and older at risk of chikungunya virus infection,” said Paul Chaplin, President and CEO of Bavarian Nordic. Bavarian Nordic also completed the submission of a Biologics License Application (BLA) for the CHIKV VLP vaccine to the U.S. Food and Drug Administration (FDA) in June 2024, potentially also supporting a US approval of the vaccine in the first half of 2025. About Cccvaccine CHIKV VLP is an adjuvanted VLP-based vaccine candidate for active immunization to prevent disease caused by CHIKV infection. Pending regulatory approval, the single-dose vaccine will be made in a pre-filled syringe, designed to ease administration by saving vaccinators' time and reducing the risk of administrative errors. The CHIKV VLP vaccine candidate received Breakthrough Therapy designation and Fast Track designation from the FDA in October 2020 and April 2018, respectively, and PRIME designation from the EMA in September 2019. These designations are designed to facilitate the development or expedite review of medicines that either target an unmet medical need or may demonstrate substantial improvement over available therapy. In February 2024, the Committee for Medicinal Products for Human Use (CHMP) under EMA granted accelerated assessment for the MAA for the CHIKV VLP vaccine candidate based on the vaccine’s major interest for public health and therapeutic innovation. Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), which belongs to the group of arboviruses like dengue virus. CHIKV disease typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. While mortality is relatively low, morbidity is high; nearly 50% of individuals with CHIKV disease have debilitating long-term symptoms that can intensify with age. In the past 20 years, the CHIKV has emerged in several previously non-endemic regions in Asia, Africa, southern Europe, and the Americas, often causing large unpredictable outbreaks. Recent data1 suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to lack of proper testing. Bavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are a global leader in smallpox and mpox vaccines, supplied to governments to enhance public health preparedness and have a strong portfolio of vaccines for travelers and endemic diseases. For more information visit www.bavarian-nordic.com. 1 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. The content above comes from the network. if any infringement, please contact us to modify.

Fast TrackVaccineBreakthrough Therapy

18 Jun 2024

·www.globenewswire.com

Bavarian Nordic Completes BLA Submission to U.S. FDA for its Chikungunya Vaccine Candidate

First regulatory submission completed for CHIKV VLP seeking approval of the vaccine candidate for immunization against chikungunya virus infection in individuals 12 years of age and older Represents first BLA for a chikungunya vaccine for adolescents June 17, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced the completion of the rolling submission process which was initiated in April 2024 with the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA) for the licensure of its CHIKV VLP vaccine candidate for immunization against chikungunya virus infection in individuals 12 years of age and older. Pending acceptance from the FDA, the BLA could support a potential approval of the vaccine in the first half of 2025. The BLA submission includes results from two phase 3 clinical trials in more than 3,600 healthy individuals 12 years of age and older, demonstrating that the CHIKV VLP vaccine was highly immunogenic, as demonstrated by the strong induction of chikungunya neutralizing antibodies against chikungunya 21 days after vaccination, with antibody titers equal to or above the threshold agreed with authorities as a marker of seroprotection. The CHIKV VLP vaccine was well-tolerated across both studies and vaccine-related adverse events were mainly mild or moderate in nature. Bavarian Nordic also intends to submit a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) by the end of the first half 2024. The MAA has already been granted accelerated assessment, which means the CHIKV VLP vaccine could potentially obtain approval by the European Commission in the first half of 2025. “The completion of the BLA submission marks a significant milestone in the development of our CHIKV VLP vaccine and represents an important contribution to the development of preventative solutions for individuals 12 years of age and older at risk of chikungunya virus from bites by infected mosquitos. With the near-term anticipated MAA submission to EMA, we are looking towards potential approval of the vaccine in the first half of 2025 and subsequent launch in both the US and EU,” said Paul Chaplin, President and CEO of Bavarian Nordic. CHIKV VLP is an adjuvanted VLP-based vaccine candidate for active immunization against chikungunya disease. Pending regulatory approval, the single-dose vaccine will be made in a pre-filled syringe, designed to ease administration by saving vaccinators' time and reducing the risk of administrative errors. The CHIKV VLP vaccine candidate received Breakthrough Therapy designation and Fast Track designation from the FDA in October 2020 and April 2018, respectively, and PRIME designation from the EMA in September 2019. These designations are designed to facilitate the development or expedite review of medicines that either target an unmet medical need or may demonstrate substantial improvement over available therapy. In February 2024, the Committee for Medicinal Products for Human Use (CHMP) under EMA granted accelerated assessment for the MAA for the CHIKV VLP vaccine candidate. Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), which belongs to the group of arboviruses like dengue virus. CHIKV disease typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. While mortality is relatively low, morbidity is high; nearly 50% of individuals with CHIKV disease have debilitating long-term symptoms that can intensify with age. In the past 20 years, the CHIKV has emerged in several previously non-endemic regions in Asia, Africa, southern Europe, and the Americas, often causing large unpredictable outbreaks. Recent data1 suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to lack of proper testing. Bavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are a global leader in smallpox and mpox vaccines, supplied to governments to enhance public health preparedness and have a strong portfolio of vaccines for travelers and endemic diseases. For more information visit www.bavarian-nordic.com. 1 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. The content above comes from the network. if any infringement, please contact us to modify.

VaccineFast TrackBreakthrough TherapyClinical Result

100 Deals associated with PXVX-0317

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Chikungunya Fever	NDA/BLA	US	Bavarian Nordic A/S	29 Apr 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03992872 (WRAIR, Biospace) Manual	Phase 2	Alphavirus Infections \| Chikungunya Fever	60	PXVX 0317	(octjgkfixh) = 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. phpikcxodx (rmjsabreni )	Positive	01 Nov 2022
NCT02562482 (Pubmed \| J Coll Physicians Surg Pak) Manual	Phase 2	Chikungunya Fever	400	PXVX-0317	(epbgoevetj) = wdedwruncg qfldufmpse (yxysgmxjkf ) View more	Positive	14 Apr 2020
				Placebo	(epbgoevetj) = mgwcgwdomq qfldufmpse (yxysgmxjkf ) View more
NCT02562482 (VRC-CHKVLP059-00-VP \| phase 2, CTgov)	Phase 2	Chikungunya Fever	400	VRC-CHKVLP059-00-VP (Group 1: VRC-CHKVLP059-00-VP 20 mcg)	(cyivijewuh) = uhwjjrjesf lggmxskwbo (uiugnaaxmj, culexcvmvk - hxtwravvmd) View more	-	14 May 2019
				VRC-PBSPLA043-00-VP (Group 2: Placebo (VRC-PBSPLA043-00-VP))	(cyivijewuh) = kchjchwahr lggmxskwbo (uiugnaaxmj, iflabsvhpa - xvuzktdkhs) View more
NCT03483961 (PipelineReview) Manual	Phase 2	Chikungunya Fever	415	PXVX-0317	(iffxkqzoom) = mkayriixsx sihgfkmfye (ubvcfwnllr ) View more	Positive	17 Apr 2019
NCT01489358 (CTgov)	Phase 1	Chikungunya Fever	25	VRC-CHKVLP059-00-VP (Group 1: 10 mcg VRC-CHKVLP059-00-VP)	zzlgrbujrl(mzslpeyicv) = cwybspbpbp aiqdvaxbzp (ghwuhkpzau, qmvvilbkof - zrtluiiqoe) View more	-	12 Apr 2016
				VRC-CHKVLP059-00-VP (Group 2: 20 mcg VRC-CHKVLP059-00-VP)	zzlgrbujrl(mzslpeyicv) = fliygcjgyx aiqdvaxbzp (ghwuhkpzau, lpftlssncg - jqymnpggwe) View more

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