摘要
本研究采用随机、双盲、有安慰剂对照的实验设计，对国产血源性乙肝疫苗的安全性、免疫原性和有效性进行了现场效果评价。１年的效果评价表明，所用国产血源性乙肝疫苗的抗－ＨＢｓ应答率为９３．１％，对ＨＢＶ感染的保护效率为９３．４％，对ＨＢｓＡｇ阳性的保护率为１００％。长期效果观察发现，疫苗接种后４年保护率，单项低水平抗－ＨＢｓ（Ｓ／Ｎ：２．１～１０）组为８１．９％，ＨＢＶ标志全阴性组为７３．５％。单项低水平抗－ＨＢｓ阳性者与血清中ＨＢＶ标志全阴性者一样，对ＨＢＶ感染是易感者，而非免疫者，对接种乙肝疫苗也能获得一定效果。采用减量疫苗接种和减量加强接种与大剂量疫苗接种的近期免疫学效果相同；长期效果观察发现，减量和常规剂量接种虽可产生相同的免疫学效果，但从保护效价和有效比率来看，减量接种的长期流行病学效果则不如常规剂量接种显著。对无应答和弱应答者复种１针疫苗后，具有良好的抗体应答，但较缓慢，且抗体持续性也较差；复种前抗体滴度越低，复种后抗体上升的幅度越大，效果越明显；初种应答好者，对复种应答也好；复种前抗－ＨＢｓ滴度（Ｓ／Ｎ值）≥５０者，复种后不能诱导产生更高水平的抗体。
We assessed the
efficacy of a plasma- derived hepatitis B vaccine made in CHi-na in randomized , double-blind
and placebo-controlled trial. The results of short-term(oneyear)efficacy evaluation suggested
that the vaccine had satisfactory safety and immunogenic-ity and the protection rate for HBV
infection and HBsAg positive was 93.4%and l00%,re-spectively. Four years observation
showed that the protection rate of hepatitis B vaccine a-gainst HBV infection was 80%.The
protection rate was l00%if only HBsAg was consid-ered. The study demonstrated that isolated
low levels anti-HBs did not persist;like subje-cts with negativity of all HBV marker,subjects with
isolated low levels of anti- HBs werethese persons who are susceptible to HBV infection and
that they can obtain protective eff-fects from the inoculation of hepatitis B vaccine. We found
that the vaccinations of reduceddoses and routine doses of Chinese- produced plasma derived
hepatitis B vaccine may inducebasically similar immunological efficacy,but according to
analyses of protection rate and effi-cacy index, long- term efficacy of epidemiology of
vaccinations of reduced doses of the vaccineis less significant than that of routine doses of
vaccine.Our study results suggested thatmost of the non- responders and hypo-responders
responde to a dose revaccination,but anti-HBs concentration increases slowly and persistences
of antibodies is poor. Anti- HBs concen-tration did not rise significantly after revaccination of the
children with preexisting anti-HBstitre(S/N)≥50.Immune responses to a revaccination dose
correlated with the initial maxi-mal anti-HBs leves after the basic course immunization.
出处
《河南医学研究》
CAS
1995年第3期193-198,共6页
Henan Medical Research
关键词
乙型肝炎
乙型肝炎疫苗
效果评价
复种
疫苗
hepatitis B vaccine,efficacy evaluation,reduced dose vaccination isolatedlow levels
of anti-HBs positive,revaccination
