A new hepatitis B vaccine containing HBeAg in addition to HBsAg

A new vaccine is reported which contains HBeAg in addition to highly purified HBsAg. The rationale for this approach depends on the following data indicating that anti-HBe/anti-HBc may play an active role in prevention of HBV infection; (1) active immunization of chimpanzees with HBeAg(s) devoid of detectable HBsAg protected against subsequent challenge with HBV; (2) passive immunization of chimpanzees with an anti-HBe/anti-HBc intravenous immunoglobulin devoid of anti-HBs significantly delayed and appeared to attenuate HBV infection following subsequent challenge with HBV. The purification procedure utilized for production of the NYBC vaccine was designed to accomplish a high degree of purification with minimal use of complex equipment. This may facilitate eventual utilization of the vaccine on a mass scale for prevention of the HBV carrier state in high prevalence regions of the world. This procedure uses PEG precipitations and hydroxylapatite adsorption steps, followed by only a single isopycnic separation in a zonal rotor, to achieve a vaccine which is substantially free of serum proteins and detectable HBV DNA yet contains immunogenic quantities of HBsAg and HBeAg. The vaccine is inactivated by Tween 80 and formalin. Four lots have passed chimpanzee safety tests; two of them have been tested in clinical trials.