Kaufmann R, Mondorf A W, Uthemann H, Bauer H, Prince A M
Dev Biol Stand. 1983;54:229-35.
A hepatitis B vaccine which has been prepared from HBsAg and HBeAg positive human plasma and which consists of purified HBsAg in an alum suspension was investigated for safety and immunogenicity in a clinical trial. Twenty-three anti-HBs seronegative volunteers received three injections each of 40 micrograms HBsAg intramuscularly. No rise in serum transaminase activities occurred during the follow-up period, and none of the volunteers developed clinical signs related to viral hepatitis. Only minor side reactions like burning or reddening at the site of injection were reported by the volunteers. 100% seroconversion occurred within 150 days after first vaccination. The subsequent two vaccinations caused a strong booster effect.
一种由乙肝表面抗原（HBsAg）和乙肝e抗原（HBeAg）阳性人血浆制备的乙肝疫苗，其成分为纯化的HBsAg混悬于明矾中，在一项临床试验中对其安全性和免疫原性进行了研究。23名抗-HBs血清阴性的志愿者肌肉注射了3次，每次40微克HBsAg。在随访期间，血清转氨酶活性没有升高，且没有志愿者出现与病毒性肝炎相关的临床症状。志愿者仅报告了注射部位有轻微的副作用，如烧灼感或发红。首次接种疫苗后150天内血清转化率达100%。随后的两次接种产生了强烈的加强效果。
