An effective, plasma-derived hepatitis B vaccine has been available commercially since 1982, but its acceptance by the targeted high-risk populations has been quite low. This may be because of cost and concerns related to its source, i.e., plasma from donors who may be at high risk of other infections. The need for a less expensive vaccine that would be more acceptable to potential recipients prompted the committee to include a new hepatitis B vaccine as a candidate in this report.

One additional reason for the need for a new hepatitis B vaccine is that with use of the present vaccine plus immune globulin, the domestic (U.S.) source of the present vaccine, i.e., infected individuals, could considerably diminish or even disappear. In fact, to the extent that effective modalities are found for dealing with chronic HBsAg carriers, a conflict of interest could arise concerning preservation of vaccine “source material.”

Symptoms of acute hepatitis B virus (HBV) infection include nausea, vomiting, abdominal pain, generalized myalgia with occasional joint pain, urticarial rash, and jaundice. HBV infection also is associated with certain immune complex diseases (polyarteritis nodosa and glomerulonephritis) and with acrodermatitis in young children. Severe cases of hepatitis B may require hospitalization, and death usually follows fulminant hepatitis. Infection is subclinical in one-third of all cases (Francis and Maynard, 1979). Of symptomatic cases in otherwise healthy adults, approximately half involve jaundice, and the other half involve more generalized symptoms. Children infected with HBV are much less likely to have symptoms of hepatitis; probably less than one in a