Clements M L, Miskovsky E, Davidson M, Cupps T, Kumwenda N, Sandman L A, West D, Hesley T, Ioli V, Miller W
Center for Immunization Research, School of Hygiene and Public Health, Johns Hopkins University, Baltimore, Maryland 21205.
J Infect Dis. 1994 Sep;170(3):510-6. doi: 10.1093/infdis/170.3.510.
A single-blind, multicenter, phase II trial of yeast recombinant hepatitis B virus (HBV) vaccines containing surface antigen (S) alone or with PreS2 (PreS2 + S) was conducted in 282 healthy HBV-seronegative adults aged 20-59 years. Each volunteer was randomly assigned to receive HBV vaccine containing 10 micrograms of S or one of three doses of PreS2 plus S: 2 + 10 micrograms, 4 + 20 micrograms, or 8 + 40 micrograms. The level of antibody to HBV surface antigen reached depended on the dose of S, not PreS2, received. In each vaccine group, volunteers 20-39 years old had higher titers of anti-PreS2 and antibody to S than those 40-59 years old. The age-related effect on immune response to HBV vaccination suggests that adults should be immunized against hepatitis B at as early an age as possible and that older persons may need a higher dose or booster immunizations to achieve durable immunity.
在282名年龄在20至59岁的健康乙肝血清阴性成年人中开展了一项单盲、多中心、II期试验，该试验使用了仅含表面抗原（S）或含前S2（前S2+S）的酵母重组乙肝病毒（HBV）疫苗。每位志愿者被随机分配接受含10微克S的乙肝疫苗或三种剂量的前S2加S疫苗之一：2+10微克、4+20微克或8+40微克。所达到的乙肝表面抗原抗体水平取决于所接受的S剂量，而非前S2剂量。在每个疫苗组中，20至39岁的志愿者的抗前S2和S抗体滴度高于40至59岁的志愿者。年龄对乙肝疫苗免疫反应的影响表明，成年人应尽早接种乙肝疫苗，且年长者可能需要更高剂量或加强免疫以获得持久免疫力。
