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▎WuXi AppTec Content Team Editor On February 14, 2022, Bavarian Nordic announced that the U.
S.
Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the vaccine candidate MVA-BN RSV for active immunization of adults 60 years of age or older to prevent respiratory syncytial virus (RSV) caused by lower respiratory tract disease
.
The designation is based on positive preliminary clinical trial results obtained with MVA-BN RSV, indicating that it may provide significant improvements in clinically important endpoints compared to existing therapies
.
Bavarian Nordic plans to initiate a large Phase 3 clinical trial of MVA-BN RSV in 2022
.
RSV is a very common infectious agent, divided into two subtypes according to antigenicity: type A and type
B.
RSV can cause seasonal epidemics of lower respiratory tract infections (LRTIs), including bronchiolitis and pneumonia
.
The initial symptoms of these diseases are similar to those of a cold, but if the infection is not controlled in time, the disease can rapidly progress to a serious and life-threatening lower respiratory tract infection, which can also lead to subsequent asthma and bronchiolitis
.
High-risk groups typically include infants and young children and elderly/immunocompromised individuals
.
However, so far, there are no effective treatments and approved preventive vaccines specifically for RSV
.
MVA-BN RSV is a vaccine candidate developed by Bavarian Nordic to prevent RSV and is currently targeting elderly individuals
.
The vaccine contains 5 different RSV antigens to stimulate a broad immune response against two RSV subtypes (A and B), thus mimicking the natural immune response following RSV infection
.
The design of combining 5 antigens simultaneously is what differentiates MVA-BN RSV from other RSV vaccine candidates currently under development
.
Image credit: 123RF Last year, the company announced the results of a double-blind, placebo-controlled Phase 2 clinical trial
.
The trial was conducted in healthy adult volunteers aged 18-50 years who were randomized to receive a single inoculation of MVA-BN RSV or placebo followed by an intranasal infection with the RSV A strain 28 days later
.
The trial met its primary endpoint of significantly lower viral load in the vaccinated group (n=30) compared to the placebo (n=31)
.
At the same time, clinical symptoms commonly associated with RSV infection were significantly reduced in vaccinated subjects, with the MVA-BN RSV vaccine showing up to 79% efficacy in preventing symptomatic RSV infection
.
In addition, another Phase 2 clinical trial in 421 elderly subjects aged 55 years and older demonstrated that the vaccine was well tolerated, induced broad and durable anti-RSV antibody and T-cell responses, and may be effective in preventing RSV is an important mucosal immune response
.
The phase 2 program in elderly subjects included revaccination of subjects 1 year later, followed by a rapid and significant increase in immune response, especially in subjects who were the least immune before booster vaccination
.
Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, said: "The development of an RSV vaccine is one of our key priorities and can help meet the significant unmet need for preventive treatment, especially for those who may be at risk for serious complications of the disease.
elderly group
.
Our vaccine candidate has a unique approach that employs five RSV-specific antigens, thereby stimulating broad antibody and cellular immune responses against RSV
.
Based on the encouraging results in a human trial last year, we plan to initiate a Phase 3 clinical trial this year and look forward to working closely with the US FDA on our path to vaccine licensing
.
"Reference: [1] Bavarian Nordic Announces Breakthrough Therapy Designation For Its Rsv Vaccine Candidate For The Prevention Of Respiratory Syncytial Virus In Older Adults.
Retrieved February 14, 2022, from https:// news/news.
aspx?news=6478Disclaimer: WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only, and the opinions in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support Or object to the views in the article
.
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.
S.
Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the vaccine candidate MVA-BN RSV for active immunization of adults 60 years of age or older to prevent respiratory syncytial virus (RSV) caused by lower respiratory tract disease
.
The designation is based on positive preliminary clinical trial results obtained with MVA-BN RSV, indicating that it may provide significant improvements in clinically important endpoints compared to existing therapies
.
Bavarian Nordic plans to initiate a large Phase 3 clinical trial of MVA-BN RSV in 2022
.
RSV is a very common infectious agent, divided into two subtypes according to antigenicity: type A and type
B.
RSV can cause seasonal epidemics of lower respiratory tract infections (LRTIs), including bronchiolitis and pneumonia
.
The initial symptoms of these diseases are similar to those of a cold, but if the infection is not controlled in time, the disease can rapidly progress to a serious and life-threatening lower respiratory tract infection, which can also lead to subsequent asthma and bronchiolitis
.
High-risk groups typically include infants and young children and elderly/immunocompromised individuals
.
However, so far, there are no effective treatments and approved preventive vaccines specifically for RSV
.
MVA-BN RSV is a vaccine candidate developed by Bavarian Nordic to prevent RSV and is currently targeting elderly individuals
.
The vaccine contains 5 different RSV antigens to stimulate a broad immune response against two RSV subtypes (A and B), thus mimicking the natural immune response following RSV infection
.
The design of combining 5 antigens simultaneously is what differentiates MVA-BN RSV from other RSV vaccine candidates currently under development
.
Image credit: 123RF Last year, the company announced the results of a double-blind, placebo-controlled Phase 2 clinical trial
.
The trial was conducted in healthy adult volunteers aged 18-50 years who were randomized to receive a single inoculation of MVA-BN RSV or placebo followed by an intranasal infection with the RSV A strain 28 days later
.
The trial met its primary endpoint of significantly lower viral load in the vaccinated group (n=30) compared to the placebo (n=31)
.
At the same time, clinical symptoms commonly associated with RSV infection were significantly reduced in vaccinated subjects, with the MVA-BN RSV vaccine showing up to 79% efficacy in preventing symptomatic RSV infection
.
In addition, another Phase 2 clinical trial in 421 elderly subjects aged 55 years and older demonstrated that the vaccine was well tolerated, induced broad and durable anti-RSV antibody and T-cell responses, and may be effective in preventing RSV is an important mucosal immune response
.
The phase 2 program in elderly subjects included revaccination of subjects 1 year later, followed by a rapid and significant increase in immune response, especially in subjects who were the least immune before booster vaccination
.
Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, said: "The development of an RSV vaccine is one of our key priorities and can help meet the significant unmet need for preventive treatment, especially for those who may be at risk for serious complications of the disease.
elderly group
.
Our vaccine candidate has a unique approach that employs five RSV-specific antigens, thereby stimulating broad antibody and cellular immune responses against RSV
.
Based on the encouraging results in a human trial last year, we plan to initiate a Phase 3 clinical trial this year and look forward to working closely with the US FDA on our path to vaccine licensing
.
"Reference: [1] Bavarian Nordic Announces Breakthrough Therapy Designation For Its Rsv Vaccine Candidate For The Prevention Of Respiratory Syncytial Virus In Older Adults.
Retrieved February 14, 2022, from https:// news/news.
aspx?news=6478Disclaimer: WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only, and the opinions in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support Or object to the views in the article
.
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.
