Infectious Disease

The HBV vaccine with three antigens leads to high seroprotection rates in adults

April 28, 2021

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Diaz-Mitoma F et al. Higher seroprotection rates (SPR) and anti-HBs titers in adults with a 3-antigen hepatitis B vaccine (3A-HBV) compared to a 1-antigen hepatitis B vaccine (1A-HBV): results of the PROTECT study. Presented at: NFID Annual Vaccine Research Conference; April 26-28, 2021 (virtual meeting).

Disclosure:
Diaz-Mitoma does not report any relevant financial information. At the time of publication, Healio was unable to confirm any relevant financial information for any of the other authors.

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Compared to Engerix-B, a candidate hepatitis B vaccine with three antigens resulted in significantly high seroprotection rates in all adults, including those 45 years of age and older and those with diabetes mellitus and obesity.

These results were presented at the annual virtual vaccination research conference sponsored by the National Foundation for Infectious Diseases.

Source: Adobe Stock.

A three-antigen hepatitis B vaccine from VBI Vaccines Inc produced high levels of seroprotection in adults, including those over 45 years of age and those with diabetes mellitus and obesity. Photo credit: Adobe Stock.

“Hepatitis B virus (HBV) infection in adults remains a global public health problem and prophylactic vaccination is an important preventive measure. Improved HBV vaccines are needed to provide safe and effective seroprotective protection against HBV for the elderly, obese, or those with compromised immune function, including diabetics. ” Francisco Diaz-Mitoma, MD, PhD, Chief Medical Officer at VBI Vaccines Inc., said Healio. “Currently approved HBV vaccines have decreased immunogenicity in these major immunocompromised risk populations for adults.”

According to Diaz-Mitoma, the HBV vaccine candidate with three antigens from VBI is scientifically different from other approved single antigen vaccines, prompting VBI Vaccines to develop a global phase 3 clinical program consisting of PROTECT and CONSTANT studies, to support potential filing of regulatory submissions in the US, Europe and Canada.

For the PROTECT study, the researchers conducted a double-blind, randomized, controlled phase 3 study in which the immunogenicity and safety of 3A-HBV compared with that of 1A-HBV (Engerix-B, GlaxoSmithKline) in adults aged 18 years and over, including this, was compared to stable chronic diseases. According to the study, participants were randomly given three intramuscular injections at months 0, 1, and 6. The main objectives were non-inferiority of seroprotection rates (SPR) and superiority of SPR in adults 45 years and older for 3A-HBV compared to those of 1A-HBV 4 weeks after the third dose.

According to the study, on day 196, the SPR was not inferior for participants 18 years and older and was significantly higher for 3A-HBV than for 1A-HBV (91.4% versus 76.5%), while the SPR was for participants 45 years and older 3A-HBV superior to 1A-HBV (89.4% versus 73.1%). In addition, the study showed that the SPR for participants with diabetes was significantly higher for 3A-HBV than for 1A-HBV (83.3% versus 58.3%), while the SPR for participants with a BMI greater than 30 kg / m2 for was significantly higher than 3A-HBV (89.2% versus 68.1%). The researchers added that the geometric mean concentration of serum anti-hepatitis B surface antibodies was higher for 3A HBV than for 1A HBV (1,424.5 vs 235.4 mIU / ml) on day 196 and across consistently higher across important subgroups.

“The PROTECT study showed that the VBI vaccine was able to trigger faster and more robust immune responses in adults compared to Engerix-B and was more immunogenic in immunocompromised subgroup populations, which in the past were more difficult to protect with HBV single antigen vaccines,” so Diaz-Mitoma said. “We believe that VBI’s three-antigen HBV vaccine can be a useful intervention in the fight against hepatitis B infection, with the potential to reduce morbidity and save lives.”

The vaccine is currently approved for use by VBI and is commercially available in Israel under the name Sci-B-Vac. A license application for biologics has been accepted for review by the FDA and a marketing authorization application has been accepted for review by the European Medicines Agency. According to Diaz-Mitoma, the results of PROTECT and the results of the CONSTANT study, which is running concurrently, will form the basis for approval applications in North America and Europe.

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NFID annual conference on vaccination research

NFID annual conference on vaccination research

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