Reactogenicity and immunogenicity of a new recombinant hepatitis B vaccine containing Pre S antigens: a preliminary report

Abstract

A new vaccine against hepatitis B virus (HBV) infection, produced in mammalian Chinese hamster ovary (CHO) cells, contains the small(s), middle (Pre S2) and large (Pre S1) surface proteins of HBV. Three injections of a 5-micrograms or 10-micrograms dose were administered intramuscularly (i.m.) at 0, 1 and 6 months to a group of 105 young adults, who were monitored for a period of 6 months after the third injection. Seroconversion rates were 100% after the second injection of the 5-micrograms or 10-micrograms dose. Geometric mean titres of HBsAb at 1 month after the third injection were 12,156 mIU ml-1 and 13,482 mIU ml-1 in those receiving the 5-micrograms and 10-micrograms dose respectively. The vaccine was well tolerated with no significant adverse events. These preliminary results suggest that the Pre S-s recombinant vaccine, produced in mammalian cells, is highly immunogenic, leading to 100% seroconversion in the population tested after injection of only two doses of 5 micrograms.

Clearance of Persistent Hepatitis B Virus Infection in Chinese Bone Marrow Transplant Recipients Whose Donors Were Anti–Hepatitis B Core– and Anti–Hepatitis B Surface Antibody–Positive

“…However, in a French study, 3 of 14 chronic hepatitis B patients who received three standard doses of conventional hepatitis B vaccine containing pre-S2 cleared HBV DNA [34]. Both pre-S1 and pre-S2 contain CTL and Th epitopes [35][36][37], and both domains have important immunogenetic roles in augmenting hepatitis B surface antibody responses in mice and humans [37][38][39][40]. They also prevent the attachment of HBV hepatocytes and are effective in clearing viruses [41,42].…”

Vaccines and immunotherapies for the prevention of infectious diseases having cutaneous manifestations

“…89,90 Several different types of vaccines also in development include DNA vaccines 91 and Pre-S vaccines, which incorporate the surface proteins of the hepatitis B virus. [92][93][94] The duration of immunity afforded by vaccination merits further long-term studies, but according to present data, long-term efficacy is expected. 88 Antibody levels decline rapidly in the first year after vaccination and then level off to a slow pace of decline.…”

Analysis of the relationship between immunogenicity and immunity for viral subunit vaccines

“…Separate subunits may react in unexpected ways when combined together in a vaccine, in terms both of the overall immune response and the protection from infection and disease afforded to the individual. An important issue in vaccine development has therefore been to evaluate the signi®cance of including additional subunits (such as preS) in a vaccine [Leroux-Roels et al, 1997;Suzuki et al, 1994;Zuckerman et al, 1997;Hourvitz et al, 1996;Pillot et al, 1995;Katkov et al, 1994]. This evaluation is based increasingly on antibody levels alone.…”