Courier's stimulating antibody level is 3.5 to 7.5 times that of the approved vaccine, and the results of phase 3 clinical trials of the new hepatitis B vaccine are released

▎Editor of WuXi AppTec's content team On October 13, 2021, VBI Vaccines announced that it is investigating the third-generation 3 hepatitis B virus (HBV) candidate vaccine Sci-B-Vac, which is being tested in 18-45-year-old adults.
Key Phase 3 clinical trial data, published in The Journal of the American Medical Association Network Open
.

This study aims to evaluate the equivalence of 3 different batches of Sci-B-Vac vaccine, and to evaluate the immunogenicity of 2 and 3 doses of Sci-B-Vac, compared with the approved single antigen HBV vaccine.
And security
.

The test results showed that compared with the active control group, in all three batches, the candidate vaccine of VBI showed a robust and consistent immune response after two and three vaccinations, and the subjects had higher serum levels.
Protection rate (SPR) and geometric mean antibody concentration (GMC)
.

Hepatitis B is one of the most important infectious disease threats in the world, with more than 290 million people infected worldwide
.

HBV infection is the main cause of liver disease, and current treatment methods are difficult to cure.
Many patients will develop liver cancer secondary
.

Every year, about 900,000 people die from complications of chronic HBV infection, such as liver decompensation, liver cirrhosis, and hepatocellular carcinoma
.

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
.

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.
Protection
.

This phase 3 clinical trial enrolled 2838 healthy adults aged 18-45
.

They were vaccinated 3 times on day 0, day 28, and day 168 of the trial
.

The key results of the test are as follows: According to the detection of the geometric mean concentration of the antibody on the 196th day of the test, the three batches of VBI vaccine produced in succession reached the main end point of batch-to-batch consistency
.

The test on the 168th day of the experiment showed that after the two vaccination, the seroprotection rate of subjects vaccinated with Sci-B-Vac reached 90.
4%, while that of the active control group was 51.
6%, which increased to 99.
3% and 94.
8 after the third vaccination.
%
.

The test on the 168th day of the experiment showed that after two vaccination, the average GMC of the VBI vaccine group was 7.
5 times higher than that of the active control group
.

After 3 vaccinations (day 196), the average GMC of the VBI vaccine group was 3.
5 times higher
.

The observed safety and tolerability are consistent with previous studies, and no new safety risks have been found
.

Picture source: Professor Timo Vesikari, the principal investigator of the 123RF trial, commented: “The HBV infection rate is highest in adults aged 25-49
.

However, this population also has the lowest compliance rate to the whole course of vaccination
.

This pivotal phase 3 clinical trial The test data has important public health significance, that is, it proves that compared with the traditional single-antigen HBV vaccine, the 3-antigen HBV candidate vaccine can lead to a higher seroprotection rate and The antibody titer increases
.

In addition, these data again support the established safety characteristics of the vaccine
.

"Reference: [1] VBI Vaccines Announces Publication of Results from Pivotal Phase 3 Study, CONSTANT, of VBI's Prophylactic 3-Antigen Hepatitis B Vaccine Candidate in The Journal of the American Medical Association Network Open.
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.

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