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▎Editor of WuXi AppTec's content team On May 12, 2021, VBI Vaccines (hereinafter referred to as VBI) announced that the key phase 3 clinical trial data of its preventive 3-antigen hepatitis B virus (HBV) vaccine candidate in adults is in The Lancet Infectious Published on Diseases.
This study aims to compare the immunogenicity and safety of 10 µg of the third-generation hepatitis B 3 antigen vaccine Sci-B-Vac with 20 µg of the approved single antigen hepatitis B vaccine in adults.
The results showed that regardless of the subject’s age, body mass index (BMI) or diabetes status, subjects vaccinated with Sci-B-Vac obtained a higher seroprotection rate, and the geometric mean antibody concentration (GMC) is the activity 5-8 times that of the control group.
Currently, this new vaccine is undergoing review by the US FDA and EU EMA.
Hepatitis B is one of the most important infectious disease threats in the world, with more than 290 million infected people worldwide.
Hepatitis B virus infection is the main cause of liver disease, and current treatment methods are difficult to cure, and many patients will develop secondary liver cancer.
Every year, about 900,000 people die from complications of chronic HBV infection, such as liver decompensation, liver cirrhosis, and hepatocellular carcinoma.
According to WHO statistics, one third of chronic hepatitis B virus infections worldwide are in China.
Currently, China has an estimated 90 million patients with chronic hepatitis B, of which 28 million need treatment, and 7 million need emergency treatment due to the risk of severe liver disease and cancer.
Although the current HBV vaccination program has effectively solved the problem of infants, there is a huge immune gap in certain adult groups, largely due to the poor immune response of many risk groups, such as the elderly, diabetes or kidney disease Patients, overweight adults and smokers.
Sci-B-Vac is the third-generation hepatitis B vaccine developed by VBI.
It contains HBV's Pre-S1, Pre-S2 and S surface antigens.
It has better immunogenicity and can trigger a strong serum after two or three immunizations.
Protective effects.
Image source: 123RF This phase 3 study is a randomized, controlled, double-blind trial conducted across 28 research centers in 4 countries.
A total of 1607 adults aged ≥18 years were enrolled.
Research subjects were randomly vaccinated with 10 µg Sci-B-Vac or 20 µg single antigen vaccine on days 0, 28, and 168 at a ratio of 1:1.
The results of the test showed that among adults aged 18-44, the seroprotection rate (SPR) after VBI vaccination 2 times (Day 168) was 87.
2%, which was the same as the SPR after 3 times single antigen vaccination (Day 196) Equivalent (91.
1%).
Compared with the control group, regardless of age, body mass index or diabetes status, subjects who received the VBI vaccine had a higher SPR, and the antibody GMC was 5-8 times that of the control group.
Among subjects over 45 years of age, the SPR at day 196 after the VBI vaccine candidate was 89.
4%, which was better than the control group's 73.
1%.
The safety and tolerability are consistent with the safety data of previous clinical studies.
No safety signals were observed in any vaccine group, and no new safety risks were found.
Dr.
Francisco Diaz-Mitoma, Chief Medical Officer of VBI, commented: “We believe that this vaccine candidate may become a meaningful intervention for adults against HBV.
We look forward to working hard while discussing with regulatory agencies in North America and Europe.
Provide a wide range of access to this candidate vaccine. "Reference: [1] VBI Vaccines Announces Publication of Results from Pivotal Phase 3 Study, PROTECT, of VBI's Prophylactic 3-Antigen Hepatitis B Vaccine Candidate in The Lancet Infectious Diseases.
May 12, 2021, from .
com/news/home/20210512005293/en Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.
If you need treatment plan guidance, please go to a regular hospital.
This study aims to compare the immunogenicity and safety of 10 µg of the third-generation hepatitis B 3 antigen vaccine Sci-B-Vac with 20 µg of the approved single antigen hepatitis B vaccine in adults.
The results showed that regardless of the subject’s age, body mass index (BMI) or diabetes status, subjects vaccinated with Sci-B-Vac obtained a higher seroprotection rate, and the geometric mean antibody concentration (GMC) is the activity 5-8 times that of the control group.
Currently, this new vaccine is undergoing review by the US FDA and EU EMA.
Hepatitis B is one of the most important infectious disease threats in the world, with more than 290 million infected people worldwide.
Hepatitis B virus infection is the main cause of liver disease, and current treatment methods are difficult to cure, and many patients will develop secondary liver cancer.
Every year, about 900,000 people die from complications of chronic HBV infection, such as liver decompensation, liver cirrhosis, and hepatocellular carcinoma.
According to WHO statistics, one third of chronic hepatitis B virus infections worldwide are in China.
Currently, China has an estimated 90 million patients with chronic hepatitis B, of which 28 million need treatment, and 7 million need emergency treatment due to the risk of severe liver disease and cancer.
Although the current HBV vaccination program has effectively solved the problem of infants, there is a huge immune gap in certain adult groups, largely due to the poor immune response of many risk groups, such as the elderly, diabetes or kidney disease Patients, overweight adults and smokers.
Sci-B-Vac is the third-generation hepatitis B vaccine developed by VBI.
It contains HBV's Pre-S1, Pre-S2 and S surface antigens.
It has better immunogenicity and can trigger a strong serum after two or three immunizations.
Protective effects.
Image source: 123RF This phase 3 study is a randomized, controlled, double-blind trial conducted across 28 research centers in 4 countries.
A total of 1607 adults aged ≥18 years were enrolled.
Research subjects were randomly vaccinated with 10 µg Sci-B-Vac or 20 µg single antigen vaccine on days 0, 28, and 168 at a ratio of 1:1.
The results of the test showed that among adults aged 18-44, the seroprotection rate (SPR) after VBI vaccination 2 times (Day 168) was 87.
2%, which was the same as the SPR after 3 times single antigen vaccination (Day 196) Equivalent (91.
1%).
Compared with the control group, regardless of age, body mass index or diabetes status, subjects who received the VBI vaccine had a higher SPR, and the antibody GMC was 5-8 times that of the control group.
Among subjects over 45 years of age, the SPR at day 196 after the VBI vaccine candidate was 89.
4%, which was better than the control group's 73.
1%.
The safety and tolerability are consistent with the safety data of previous clinical studies.
No safety signals were observed in any vaccine group, and no new safety risks were found.
Dr.
Francisco Diaz-Mitoma, Chief Medical Officer of VBI, commented: “We believe that this vaccine candidate may become a meaningful intervention for adults against HBV.
We look forward to working hard while discussing with regulatory agencies in North America and Europe.
Provide a wide range of access to this candidate vaccine. "Reference: [1] VBI Vaccines Announces Publication of Results from Pivotal Phase 3 Study, PROTECT, of VBI's Prophylactic 3-Antigen Hepatitis B Vaccine Candidate in The Lancet Infectious Diseases.
May 12, 2021, from .
com/news/home/20210512005293/en Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.
If you need treatment plan guidance, please go to a regular hospital.