HBV Pre-S
Description
Product Specs
The product is supplied as a sterile solution in PBS containing 25mM K2CO3.
HBV Pre-S is stable at 4°C for up to 1 week, but it is recommended to store it at -18°C or below. Avoid repeated freeze-thaw cycles.
Product Science Overview
Hepatitis B virus (HBV) is a significant global health concern, causing a spectrum of liver diseases ranging from acute hepatitis to chronic infections that can lead to life-threatening conditions such as hepatocellular carcinoma (HCC) and liver cirrhosis . The development of effective vaccines has been a crucial step in combating HBV infections.
The journey towards the development of recombinant HBV vaccines began in the 1960s when HBV was first identified as the causative agent of hepatitis B . The first recombinant DNA vaccine for HBV, known as Recombivax HB, was approved for human use in 1986 . This vaccine was a significant breakthrough, utilizing recombinant DNA technology to produce the hepatitis B surface antigen (HBsAg) in yeast cells.
The Pre-S recombinant vaccines represent an advancement over the traditional single-antigen vaccines. These vaccines include additional antigens, specifically the Pre-S1 and Pre-S2 regions of the HBV envelope, along with the S antigen. The inclusion of these additional antigens aims to enhance the immune response and provide broader protection against HBV .
The Pre-S1 and Pre-S2 regions of the HBV envelope play crucial roles in the virus’s ability to infect liver cells. By including these regions in the vaccine, the immune system is better equipped to recognize and neutralize the virus. The Pre-S recombinant vaccines have been shown to induce higher seroprotection rates and more durable immunity compared to traditional single-antigen vaccines .
Clinical trials have demonstrated the efficacy and safety of Pre-S recombinant vaccines. For instance, a Phase 3 randomized clinical trial conducted in the Russian Federation compared the immunogenicity and safety of a 3-antigen (S/pre-S1/pre-S2) hepatitis B vaccine (3AV) to a single-antigen vaccine (1AV). The study found that the 3AV induced higher seroprotection rates and had a favorable safety profile .
The Pre-S recombinant vaccines have received marketing authorization in several countries, including the United States, the European Union, the United Kingdom, and Canada . These vaccines are recommended for adults, particularly those who may not respond optimally to conventional single-antigen vaccines, such as individuals with obesity, type 2 diabetes, and smokers .
