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Hepatitis B vaccine: clinical trials in high-risk settings in France. (September 1975-September 1982).

An alum bivalent hepatitis B vaccine containing 5 micrograms/dose of formalin-inactivated and purified HBsAg has been prepared from plasma of HBeAg negative donors. Safety of the product has been controlled by compulsory testing of each batch in susceptible chimpanzees. This vaccine (HB vaccine) was used for the prophylaxis of Hepatitis B in hospital staff working in high-risk settings and patients undergoing periodic dialysis since the Autumn of 1975. Tolerance to the HB vaccine was excellent both in staff and patients as assessed by a nation-side survey on a thousand vaccinees. More than 96% of the staff developed protective levels of anti-HBs after three injections of vaccine given at one month intervals and became fully immune from HBV infection. A booster injection given at one year stimulated an anamnestic rise of anti-HBs sufficient to ensure protective levels of antibody for at least five years post-booster. The response of renal patients varied according to the age of recipients: young patients responded equally as well as the healthy staff, while patients over the sixth decade had a lower and delayed response. Because of that, a fourth injection of HB vaccine was advocated in elderly patients. Dialysis patients who developed anti-HBs either after three or four injections were fully protected against chronic HBV infections. Anti-HBs positive donors who had received a single booster injection of HB vaccine and vaccinees who had received their 12 months booster were both found to be an adequate source of high-titre anti-HBs plasma for preparing hyperimmune anti-HBs globulin. The HB vaccine which is manufactured by Institut Pasteur Production under the name HEVAC B degrees is now used world-wide for the prophylaxis of hospital acquired infection in developed countries and for the prevention of maternal-infant transmission in the endemic countries of Asia and Africa.