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.

开始日期2023-08-30

申办/合作机构

Bavarian Nordic A/S

NCT05349617

/ Completed临床3期

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.

开始日期2022-05-12

申办/合作机构

Bavarian Nordic A/S

[+1]

NCT05065983

/ Completed临床2期

A Phase 2 Open-Label Study to Assess the Safety and Immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV VLP], Aluminum Hydroxide Adjuvanted)

The objective of this study is to assess the safety and immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV VLP], aluminum hydroxide adjuvanted).

开始日期2021-10-11

申办/合作机构

Bavarian Nordic A/S

[+1]

100 项与 Chikungunya Vaccine, Recombinant (Bavarian Nordic) 相关的临床结果

登录后查看更多信息

100 项与 Chikungunya Vaccine, Recombinant (Bavarian Nordic) 相关的转化医学

登录后查看更多信息

100 项与 Chikungunya Vaccine, Recombinant (Bavarian Nordic) 相关的专利（医药）

登录后查看更多信息

155

项与 Chikungunya Vaccine, Recombinant (Bavarian Nordic) 相关的文献（医药）

2025-04-01·Lancet Microbe

Safety and immunogenicity of an adjuvanted chikungunya virus virus-like particle (CHIKV VLP) vaccine in previous recipients of other alphavirus vaccines versus alphavirus vaccine-naive controls: an open-label, parallel-group, age-matched, sex-matched, phase 2 randomised controlled study

Article

作者: Mendy, Jason ; Liggett, Dani L ; Pierson, Benjamin C ; Ghosh, Neha ; Regules, Jason A ; Richardson, Jason S ; Warfield, Kelly L ; Gardner, Christina L ; Bedell, Lisa ; Burke, Crystal W ; Saunders, David ; Lee, Christine ; Hamer, Melinda J ; McCarty, James M ; Glass, Pamela J ; Haller, Jeannine M ; Royalty Tredo, Sarah ; Sanborn, Aaron D ; Gregory, Melissa K

BACKGROUND:

Immune responses to alphavirus vaccines might be impaired when heterologous alphavirus vaccines are administered sequentially. We aimed to compare immunogenicity and safety of a chikungunya virus virus-like particle (CHIKV VLP) vaccine in previous recipients of heterologous alphavirus vaccines with alphavirus-naive controls in the USA.

METHODS:

In this open-label, parallel-group, age-matched, sex-matched, phase 2 randomised controlled trial, which was conducted at two clinical study sites in the USA, adults (aged 18-65 years) who had previously received an investigational Venezuelan equine encephalitis virus vaccine (previous alphavirus vaccine recipients; n=30) and sex-matched and age-matched alphavirus vaccine-naive controls (n=30) were intramuscularly administered one 40 μg dose of CHIKV VLP vaccine on day 1. Immunogenicity was based on serum neutralising antibodies assessed by an in-vitro luciferase-based anti-CHIKV NT₈₀ neutralisation assay. The primary immunogenicity endpoint, which was assessed in the immunogenicity evaluable population (CHIKV VLP-vaccinated participants who had no important protocol deviations, had not received a prohibited medication, and provided evaluable serum sample results for baseline and on day 22), was to compare the proportion of previous alphavirus vaccine recipients with the proportion of alphavirus vaccine-naive controls who reached seroconversion 21 days after vaccination (ie, study day 22) with a single dose of CHIKV VLP vaccine, based on a four-fold increase of CHIKV neutralising antibodies compared with baseline. The significance of the comparison of the two groups was assessed using Fisher's exact test. The proportion with seroconversion in each group is presented with 95% CIs calculated using the Wilson method. The difference and 95% CIs for this difference was calculated based on Newcombe hybrid score method. An ANOVA model was fit with log₁₀-transformed titre as the dependent variable, and study arm, age, and sex as predictors. Least squares means, difference, and 95% CIs were back-transformed and reported as geometric mean titres (GMTs). This trial is registered with ClinicalTrials.gov, NCT03992872.

FINDINGS:

Between Nov 20, 2019, and Jan 19, 2021, 60 participants (20 [33%] female and 40 [67%] male; 40 (67%) White; median age 47·0 years [IQR 13·5]), 30 previous alphavirus vaccine recipients and 30 alphavirus vaccine-naive controls, were enrolled, vaccinated with CHIKV VLP, and completed the trial. The anti-CHIKV neutralising antibody seroconversion rate at day 22 was 100% (95% CI 88·6-100) in both groups. GMTs peaked in previous alphavirus vaccine recipients and alphavirus vaccine-naive controls at day 22 (2032·5 [95% CI 1413·0-2923·6] and 2299·2 [1598·1-3307·8], respectively) and were similar between the groups on day 22 and all subsequent visits. A higher proportion of previous alphavirus vaccine recipients (93·3% [95% CI 78·7-98·2]) had a four-fold neutralising antibody increase at day 8 than did alphavirus vaccine-naive controls (66·7% [48·8-80·8]; p=0·021). 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.

INTERPRETATION:

CHIKV VLP vaccine was well tolerated and similarly immunogenic in both alphavirus vaccine-naive participants and previous recipients of a heterologous alphavirus vaccine. There were no significant differences in adverse events between the groups. The results of this study support the use of CHIKV VLP vaccine in individuals with previous alphavirus vaccine exposure.

FUNDING:

Defense Health Program, Emergent Travel Health, and Bavarian Nordic A/S.

2025-04-01·LANCET

Chikungunya virus virus-like particle vaccine safety and immunogenicity in adolescents and adults in the USA: a phase 3, randomised, double-blind, placebo-controlled trial

Article

作者: Warfield, Kelly L ; Jenkins, Victoria A ; Richardson, Jason S ; Tindale, Lauren C ; Muhammad, Sufia ; Bedell, Lisa ; Mendy, Jason ; Tredo, Sarah Royalty ; Loreth, Tobi ; Ajiboye, Patrick ; Ramanathan, Roshan ; Caso, Jorge T ; Anderson, Deborah M

BACKGROUND:

Chikungunya disease is a growing global public health concern. Vimkunya (previously chikungunya virus virus-like particle vaccine, previously PXVX0317) is a single-dose, pre-filled syringe for intramuscular injection. Here, we report safety, tolerability, and immunogenicity data for Vimkunya versus placebo in healthy adolescents and adults aged 12-64 years, and evaluate lot-to-lot consistency.

METHODS:

This pivotal phase 3, randomised, double-blind, placebo-controlled, parallel-group trial was done at 47 clinical trial sites in the USA. Eligible participants were healthy adolescents and adults aged 12-64 years. Participants were divided into three age strata (12-17 years, 18-45 years, and 46-64 years) within each site and randomly assigned (2:2:2:1) to receive one of three consecutively manufactured lots of Vimkunya or placebo (same excipient composition without chikungunya virus virus-like particle or aluminium hydroxide components) on study day 1. Neither participants, nor clinical site personnel, nor the funder knew participants' individual treatment assignments until all participants completed their involvement in the trial and the database was cleaned and locked. Participants attended a screening visit, followed by a day 1 visit that included random assignment, blood sample collection, and administration of a single dose of Vimkunya or placebo by intramuscular injection in the deltoid muscle. The coprimary endpoints were: the difference in chikungunya virus serum neutralising antibody seroreponse rate (vaccine minus placebo) at day 22; chikungunya virus serum neutralising antibody geometric mean titre (GMT) at day 22 for vaccine and placebo; and chikungunya virus serum neutralising GMT ratio at day 22 between all three pairs of vaccine lots (A:B, B:C, and A:C) in adults aged 18-45 years. The trial is registered with ClinicalTrials.gov, NCT05072080 and EudraCT, 2023-001124-42.

FINDINGS:

Between Sept 29, 2021, and Sept 23, 2022, 4215 participants were screened, of whom 3258 were eligible and enrolled (1667 [51·2%] female and 1591 [48·8%] male), and 3254 (99·9%) received either Vimkunya (n=2790) or placebo (n=464). The immunogenicity evaluable population included 2983 participants, of whom 2559 received Vimkunya and 424 received placebo. At day 22, 2503 (97·8%) of 2559 participants in the Vimkunya group had a seroresponse, compared with five (1·2%) of 424 participants in the placebo group for the immunogenicity evaluable population. The seroreponse rate difference was 96·6% (95% CI 95·0-97·5; p<0·0001). In the immunogenicity evaluable population, chikungunya virus serum neutralising antibody GMT at day 22 for the vaccine group was 1618 and for the placebo group was 7·9 (p<0·0001). At day 22, the serum neutralising GMT ratios for the pairs of lots (A:B, B:C, and A:C) were 0·98 (95% CI 0·85-1·14), 0·97 (0·84-1·12), and 0·95 (0·82-1·10), respectively. Vimkunya had a favourable safety profile; most adverse events were self-limiting and grade 1 or 2 in severity. The most common adverse events were injection site pain (656 [23·7%] of 2764 participants in the vaccine group), fatigue (551 [19·9%] of 2764), headache (498 [18·0%] of 2765), and myalgia (486 [17·6%] of 2764).

INTERPRETATION:

Vimkunya induces a rapid and robust immune response. These findings support the potential for this vaccine to protect individuals aged 12-64 years from disease caused by chikungunya virus.

FUNDING:

Emergent BioSolutions and Bavarian Nordic.

2025-04-01·LANCET

Chikungunya virus virus-like particle vaccine safety and immunogenicity in adults older than 65 years: a phase 3, randomised, double-blind, placebo-controlled trial

Article

作者: Bedell, Lisa ; Ajiboye, Patrick ; Mendy, Jason ; Richardson, Jason S ; Ramanathan, Roshan ; Jenkins, Victoria A ; Muhammad, Sufia ; Tindale, Lauren C ; Tredo, Sarah Royalty ; Anderson, Deborah M ; Loreth, Tobi

BACKGROUND:

Adults older than 65 years are at increased risk for atypical presentations of chikungunya disease, as well as for severe outcomes including death.

METHODS:

In this phase 3, randomised, double-blind, placebo-controlled, parallel-group trial, adults aged 65 years and older received a single intramuscular dose of Vimkunya (previously chikungunya virus virus-like particle vaccine) or placebo at ten sites in the USA. Participants, clinical site personnel, and the sponsor were masked to individual treatment assignments until all participants had completed their involvement in the trial and the database was cleaned and locked. Baseline and postvaccination chikungunya virus serum neutralising antibody (SNA) titres (NT₈₀) were assessed at selected timepoints. Safety was assessed up to 183 days after dose administration in all participants from the exposed population who provided safety assessment data. This trial is registered with ClinicalTrials.gov, NCT05349617, and is completed.

FINDINGS:

Between May 12 and Dec 2, 2022, 413 participants were recruited and randomly assigned (1:1) to receive the Vimkunya vaccine (n=206) or placebo (n=207). The coprimary endpoints of immunologic superiority of chikungunya virus SNA titres compared with placebo and geometric mean titre at day 22 were met. Vimkunya induced a protective seroresponse (SNA NT₈₀≥100, considered the presumptive seroprotective antibody response) in 149 (82%) of 181 participants (95% CI 76·1-87·2) at day 15, in 165 (87%) of 189 participants (81·8-91·3) at day 22, and in 139 (76%) of 184 participants (68·9-81·2) at day 183. Although there was a slightly higher early immune response in the 65-74 years age group at day 15 compared with the 75 years and older age group, the seroresponse rates at day 22 and day 183 were similar. There were no notable differences in adverse event rates between groups, and most adverse events were grade 1 or 2 in severity and of short duration. No vaccine-related serious adverse events or deaths occurred.

INTERPRETATION:

We provide robust data from adults aged 65 years and older showing that Vimkunya is well tolerated and can provide a high rate of protection within 2 weeks postvaccination and during 6 months of follow-up.

FUNDING:

Emergent BioSolutions and Bavarian Nordic.

项与 Chikungunya Vaccine, Recombinant (Bavarian Nordic) 相关的新闻（医药）

2025-05-09

·GlobeNewswire-Health Care

Bavarian Nordic Announces Interim Results for the First Three Months of 2025

COPENHAGEN, Denmark, May 9, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today its interim financial results and business progress for the first three months of 2025. Revenue for the first three months increased by 62% to DKK 1,347 million, reflecting a strong performance in both Travel Health and Public Preparedness. Travel Health revenue increased by 52% to DKK 680 million compared to the first quarter of 2024, primarily driven by increased demand for rabies and tick-borne encephalitis (TBE) vaccines.Public Preparedness revenue increased by 83% to DKK 629 million compared to the first quarter of 2024. This exceeded initial expectations due to successful efforts to advance the deliveries of a few, but larger, existing orders into the first quarter.Other revenue was DKK 37 million. The operating profit (EBITDA) was DKK 420 million, corresponding to an EBITDA margin of 31%.Financial guidance for the full year is maintained at a revenue of DKK 5,700-6,700 million and an EBITDA margin of 26-30%. DKK million3m 20253m 20242025 GuidanceRevenue1,3478315,700 – 6,700EBITDA margin31%3%26-30% Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: “A very strong first quarter for our Travel Health business, demonstrating a 52% growth year-over-year and puts us ahead of our strategic goal of an average annual growth rate of 10-12% for this part of the business until 2027. We also recorded our first US sales of the chikungunya vaccine after its approval in February and ahead of the April recommendation from ACIP. Our phased launch plan for the vaccine is progressing as planned with the first European markets coming online over the next couple of months while we also continue our efforts to expand the regulatory approvals to other territories. Chikungunya represents an increasing public health threat across the globe, and we are proud to have entered our first partnership to improve access to the vaccine for low- and middle-income countries. In Public Preparedness, we also delivered above expectations. While this was largely due to a number of deliveries occurring ahead of plans, it goes to show the strength and scale of our manufacturing setup to meet the increased demand for our mpox/smallpox vaccine.” Highlights from the first quarter Travel Health Vimkunya was approved in the US and EU in February as the first virus-like particle (VLP)-based chikungunya vaccine and the first chikungunya vaccine for persons aged 12 years and older. Additionally, regulatory submissions were filed in the UK and Canada.Vimkunya was launched commercially in the US in March and will be launched in the first European markets later during the first half of 2025.Concurrently with the US approval of Vimkunya, Bavarian Nordic was granted a Priority Review Voucher, which the Company intends to monetize when appropriate.A strategic partnership was entered with Biological E. Limited in February, initially comprising a contract manufacturing agreement with the aim to provide capacity for the future supply of chikungunya vaccines to endemic low- and middle-income countries. Public Preparedness The freeze-dried version of JYNNEOS was approved by the U.S. Food and Drug Administration (FDA) in March for prevention of smallpox and mpox disease in adults 18 years of age and older. The approval supports the ongoing contract with the US government for stockpiling of the vaccine. Other business In January, Bavarian Nordic launched and completed a share buy-back program of DKK 150 million, with the purpose of adjusting the capital structure. Events after the reporting date In April, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Vimkunya™ for the prevention of disease caused by chikungunya virus for US persons aged 12 and older traveling to regions with an outbreak or elevated risk of chikungunya, as well as for laboratory workers with potential for exposure to chikungunya virus.In May, the UK Medicines and Healthcare products Regulatory Agency granted marketing authorization in the United Kingdom for Vimkunya® for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older.In May, the US government exercised additional options valued at USD 143.6 million under the existing contract to supply a freeze-dried formulation of JYNNEOS® smallpox vaccine, with planned delivery in 2026. Conference call and webcastThe management of Bavarian Nordic will host an investor/analyst call today at 2 pm CEST (8 am EDT) to present the interim results followed by a Q&A session. A listen-only version of the call and presentation slides can be accessed via https://edge.media-server.com/mmc/p/798tzbob/. To join the Q&A session, please register in advance via https://register-conf.media-server.com/register/BI2a5d49d1c9d64ee99d6d03297d3d4323. Contact investors:Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-nordic.com, Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600 Contact media:Nicole Seroff, Vice President Corporate Communications, nise@bavarian-nordic.com, Tel: +45 53 88 06 03 Company Announcement no. 16 / 2025 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 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. Attachment Interim Report Q1 2025

上市批准疫苗财报加速审批引进/卖出

2025-05-09

·Pharmaceutical Technology

Bavarian Nordic shares rise 7% following strong Q1 for vaccine sales

Bavarian Nordic has recently secured had key vaccine approvals for chikungunya virus and mpox/smallpox. Image credit: Shutterstock / Anne Czichos. Bavarian Nordic is successfully navigating a sentiment-changing vaccine landscape, posting Q1 revenues significantly up from the same period in 2024. The Danish vaccine specialist reported quarterly revenue of DKr1.3bn ($200m), a 62% year-over-year increase. Bavarian Nordic maintained its full year guidance of DKr5.7-DKr6.7bn. Shares in the company opened 7% higher at a price of DKr167.15 at market open, following the announcement made early on 9 May. Bavarian Nordic faced a challenging close to 2024, with Q3 revenue falling 26% compared to the same interval in 2023. Across the first nine months of the fiscal year 2024, the company experienced a 46% deficit. After some key approvals and contract signings, Bavarian Nordic has turned a corner, and its 2025 start makes for some strong financial reading. Revenue for Bavarian Nordic’s travel health business, which includes chikungunya vaccine Vimkunya and rabies shot Rabipur amongst others, increased 52% to Dkr680m. The company stated it was Rabipur and tick-borne encephalitis (TBE) vaccine Encepur that drove the higher sales compared to 2024. Vimkunya was approved in the US and UK in February, becoming the second commercially available jab alongside Valneva’s Ixchiq. Bavarian Nordic could be set for a market advantage as the vaccine is approved for people aged 12 years and older while Ixchiq is only licensed for adults. As of 8 May, Ixchiq is also under review by the European Medicines Agency (EMA) amid reports of serious side effects. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Vimkunya will likely contribute to revenue from Q2 onwards, having been launched in the US in March and set for European markets in H1 2025. Bavarian Nordic received a priority review voucher, which it expects to monetise, as part of Vimkunya’s US approval . Voucher sales have historically averaged at around $100m, facilitating a quick cash injection to biotechs selling them. For its public preparedness business, headed by smallpox/mpox vaccine Jynneos, revenue was up an immense 83% to reach Dkr629m. Bavarian Nordic stated this “exceeded initial expectations” due to orders advanced early into Q1. The company secured a regulatory win when the US Food and Drug Administration (FDA) approved a freeze-dried formulation of Jynneos, supporting the ongoing contract with the US government for stockpiling. This includes recently exercised additional options valued at $144m within the Jynneos stockpiling contract. Vaccines are under the spotlight due to a polarised landscape in the US. Health Secretary Robert F Kennedy, Jr. has voiced anti-vaccine rhetoric and doubled down on scientifically false claims. In a move last week that upped confidence from infectious disease-specialist biotechs, however, the US Department of Health and Human Services (HHS) launched a $500m initiative to accelerate the development of universal vaccines targeting viruses with pandemic potential.

疫苗上市批准

2025-05-07

·GlobeNewswire-Health Care

Bavarian Nordic Receives Marketing Authorization for Chikungunya Vaccine for Persons Aged 12 and Older in the United Kingdom

May 2, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for VIMKUNYA® (recombinant, adsorbed) for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older. The vaccine was approved following MHRA review under the international recognition procedure, which is a targeted assessment that recognizes approvals from certain other regulatory bodies, in this case the recent approval by the European Commission. Bavarian Nordic is targeting launch of the vaccine in the UK during the summer of 2025. “Chikungunya mostly represents a risk for UK citizens traveling overseas to affected regions in the Americas, Africa and Asia, but as recent research has shown, invasive mosquitos known to carry the disease have established themselves in many parts of Southern Europe and are moving further north due to climate change1,” said Paul Chaplin, President and CEO of Bavarian Nordic. “The mosquitos cannot be stopped, but with preventative measures such as vaccines, we can mitigate the impact of emerging diseases like chikungunya for those at risk, and we look forward to launching our vaccine in the UK later this year.” The UK approval of VIMKUNYA marks the third approval of Bavarian Nordic’s chikungunya vaccine, which was approved by the U.S. Food and Drug Administration (FDA) and the European Commission in February 2025.2,3 Bavarian Nordic has also submitted an application to Health Canada, potentially supporting approval of the chikungunya vaccine in the first half of 2026. Chikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). 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, CHIKV has been identified in more than 110 countries, with evidence of transmission confirmed in more than 50 countries over the past five years4. Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover within 1-2 weeks, but 30-40% of those affected may develop chronic arthritis that can last for months or even years5. In 2024, 620,000 cases of chikungunya and over 200 deaths were reported worldwide6. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile7. 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. The US, EU and UK approvals of VIMKUNYA (CHIKV VLP vaccine) were all based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. The studies met their primary endpoints, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of the vaccinated individuals, (97.8% in individuals 12 years to 64 and 87.3% in over 65 year olds). The key secondary endpoint of seroresponse rate at day 8 post vaccination was 46.6% and 96.8% at day 15 in the 12-64 year old population and 82.3% at day 15 for the over 65 population. The vaccine was well-tolerated and vaccine-related adverse events were mainly mild or moderate in nature. The most common side effects were pain at the injection site, fatigue, headache, and muscle pain. 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. 1 European Centre for Disease Prevention and Control. Increasing risk of mosquito-borne diseases in EU/EEA following spread of Aedes species. https://www.ecdc.europa.eu/en/news-events/increasing-risk-mosquito-borne-diseases-eueea-following-spread-aedes-species 2 Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older. https://www.bavarian-nordic.com/media/media/news.aspx?news=7053 3 Bavarian Nordic Receives Marketing Authorization in Europe for Chikungunya Vaccine for Persons Aged 12 and Older. https://www.bavarian-nordic.com/media/media/news.aspx?news=7056 4 Centers for Disease Control and Prevention. Areas at Risk for Chikungunya. https://www-cdc-gov.libproxy1.nus.edu.sg/chikungunya/data-maps/index.html. 5 European Centre for Disease Prevention and Control. Chikungunya virus disease. https://www.ecdc.europa.eu/en/chikungunya-virus-disease. 6 European Centre for Disease Prevention and Control. Chikungunya virus disease case notification rate per 100 000 population, January 2024-December 2024. https://www.ecdc.europa.eu/en/publications-data/chikungunya-virus-disease-case-notification-rate-100-000-population-january-2024. 7 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.

临床结果上市批准疫苗

100 项与 Chikungunya Vaccine, Recombinant (Bavarian Nordic) 相关的药物交易

登录后查看更多信息

研发状态

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
基孔肯雅热	美国	Bavarian Nordic A/S	2025-02-14

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05072080 (FDA_CBER) 人工标引	临床3期	基孔肯雅热	-	VIMKUNYA	餘鑰繭齋構膚醖艱鑰繭(鬱積簾衊繭鑰壓製窪鹹) = 艱淵鏇糧構鹹積築廠夢範衊餘蓋窪憲獵艱壓憲 (願範壓餘觸顧繭憲襯鹽, 1504.1 ~ 1695.6) 更多	积极	2025-02-14
				Placebo	餘鑰繭齋構膚醖艱鑰繭(鬱積簾衊繭鑰壓製窪鹹) = 獵觸顧獵遞觸鹽襯衊簾範衊餘蓋窪憲獵艱壓憲 (願範壓餘觸顧繭憲襯鹽, 7.0 ~ 8.8) 更多
NCT05349617 (FDA_CBER) 人工标引	临床3期	基孔肯雅热	-	VIMKUNYA	艱鬱壓鹽襯網獵願願鬱(夢膚窪鹽蓋鏇廠壓淵顧) = 糧窪艱膚壓願積築範衊網鏇鏇壓壓艱膚窪範憲 (願廠窪鏇築夢鹽鏇鑰襯, 582.3 ~ 892.7) 更多	积极	2025-02-14
				Placebo	艱鬱壓鹽襯網獵願願鬱(夢膚窪鹽蓋鏇廠壓淵顧) = 醖範範願觸顧窪繭糧觸網鏇鏇壓壓艱膚窪範憲 (願廠窪鏇築夢鹽鏇鑰襯, 6.5 ~ 10.0) 更多
NCT05349617 (CTgov)	临床3期	-	413	CHIKV VLP/adjuvant (Group 1 - PXVX0317)	壓廠鹽壓蓋選衊遞夢鑰 = 範製衊壓廠糧積齋觸觸觸鹹夢襯膚積繭繭顧餘 (積鑰廠艱獵網襯壓網範, 夢網襯鏇糧壓淵膚鏇憲 ~ 夢顧遞獵積顧願齋鹹憲) 更多	-	2024-12-13
				Placebo (Group 2 - Placebo)	壓廠鹽壓蓋選衊遞夢鑰 = 鬱醖鹹願鹹醖蓋觸築製觸鹹夢襯膚積繭繭顧餘 (積鑰廠艱獵網襯壓網範, 鹽選夢淵獵獵廠衊繭餘 ~ 蓋選簾醖淵夢獵鏇齋獵) 更多
NCT05072080 (CTgov)	临床3期	基孔肯雅热	3,258	CHIKV VLP/adjuvant (Group 1)	齋膚鬱糧選範淵艱蓋醖 = 膚鬱遞醖積壓積憲蓋願築壓淵選襯簾餘夢齋廠 (簾衊淵夢醖醖築製範膚, 鹽繭鬱壓襯襯襯簾淵構 ~ 齋鬱膚構簾積夢憲觸糧) 更多	-	2024-08-30
				CHIKV VLP/adjuvant (Group 2)	齋膚鬱糧選範淵艱蓋醖 = 襯膚積膚鹹築鹹願獵鏇築壓淵選襯簾餘夢齋廠 (簾衊淵夢醖醖築製範膚, 鑰憲糧網獵廠顧蓋齋範 ~ 獵憲構餘繭網網範衊觸) 更多
NCT02562482 (phase 2, Pubmed \| Vaccine)	临床2期	基孔肯雅热 focus reduction neutralizing antibody	400	CHIKV VLP vaccine seropositive recipients	觸積餘願鏇廠願膚鏇鬱(鏇積齋鹹鏇繭餘簾襯鑰) = 窪憲簾壓觸淵獵鬱膚廠艱簾鏇構衊餘襯製壓鏇 (顧鬱鹽觸夢簾觸窪鬱夢 )	积极	2023-10-06
				CHIKV VLP vaccine seronegative recipients	觸積餘願鏇廠願膚鏇鬱(鏇積齋鹹鏇繭餘簾襯鑰) = 衊齋憲憲鏇範艱齋鑰夢艱簾鏇構衊餘襯製壓鏇 (顧鬱鹽觸夢簾觸窪鬱夢 )
NCT05065983 (CHIKV VLP, CTgov)	临床2期	基孔肯雅热	25	CHIKV VLP, adjuvanted	簾鏇獵築壓網構顧襯醖 = 衊膚夢顧夢窪壓夢齋窪獵窪觸憲鏇淵觸醖壓淵 (製鏇壓膚餘夢觸製觸構, 簾窪範艱觸艱選憲糧窪 ~ 艱範齋簾襯蓋糧膚製願) 更多	-	2023-02-28
NCT03992872 (WRAIR, Biospace) 人工标引	临床2期	甲病毒感染 \| 基孔肯雅热	60	PXVX 0317	鹽艱願鏇餘糧蓋淵糧衊(繭繭網鹽艱蓋膚鬱糧齋) = 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. 壓餘觸遞選艱鑰網窪積 (構遞壓鏇願顧廠繭艱網 )	积极	2022-11-01
NCT02562482 (Pubmed \| J Coll Physicians Surg Pak) 人工标引	临床2期	基孔肯雅热	400	PXVX-0317	構膚鹹願膚製鏇鹽餘膚(鬱艱鏇觸獵網夢鏇顧壓) = 鑰製獵壓衊衊夢簾製鑰鬱鬱簾構壓糧鹹簾淵憲 (蓋齋壓積繭範淵壓蓋憲 ) 更多	积极	2020-04-14
				Placebo	構膚鹹願膚製鏇鹽餘膚(鬱艱鏇觸獵網夢鏇顧壓) = 膚網鹹壓願廠艱壓製鬱鬱鬱簾構壓糧鹹簾淵憲 (蓋齋壓積繭範淵壓蓋憲 ) 更多
NCT02562482 (VRC-CHKVLP059-00-VP \| phase 2, CTgov)	临床2期	基孔肯雅热	400	VRC-CHKVLP059-00-VP (Group 1: VRC-CHKVLP059-00-VP 20 mcg)	醖範淵遞憲鹹願壓構窪 = 夢遞蓋膚製艱構鹽窪築醖夢淵繭鬱築網壓鑰積 (蓋艱齋糧鬱鹽膚簾窪簾, 鹹願醖繭網膚廠鹹獵夢 ~ 淵膚艱壓廠鏇膚鑰選鏇) 更多	-	2019-05-14
				VRC-PBSPLA043-00-VP (Group 2: Placebo (VRC-PBSPLA043-00-VP))	醖範淵遞憲鹹願壓構窪 = 願鑰簾壓艱襯繭獵衊襯醖夢淵繭鬱築網壓鑰積 (蓋艱齋糧鬱鹽膚簾窪簾, 遞膚壓構選願鏇糧艱醖 ~ 獵觸鹽鹽製膚醖繭廠膚) 更多
NCT03483961 (PipelineReview) 人工标引	临床2期	基孔肯雅热	415	PXVX-0317	簾顧獵鬱構鹽餘淵鹹遞(衊繭鑰蓋觸願鹽構築襯) = 顧繭淵齋淵願鏇蓋積鬱膚鏇遞齋餘艱構鬱範製 (繭廠淵廠壓鹽膚獵壓廠 ) 更多	积极	2019-04-17