| 聂军,于光烈,骆抗先,戴子森,严燕,王安位.国产血源性乙肝疫苗免疫原性、安全性和保护效果观察[J].中华流行病学杂志,1988,9(6):332-335 |
| 国产血源性乙肝疫苗免疫原性、安全性和保护效果观察 |
| A Study on the Immunogenicity, Safety and Protective Efficacy of a Plasmaderived Hepatitis B Vaccine Made in China |
| 收稿日期: 出版日期:2021-06-01 |
| DOI： |
| 中文关键词: 乙型肝炎 血源性疫苗 免疫接种 |
| 英文关键词: Hepatitis B Plasma-derived vaccine Vaccination Intramuscular injection |
| 基金项目: |
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| 中文摘要: |
| 本文对96名HBV血清标志均阴性的健康成年男性,用随机、双盲、对照实验,采用0、1、6方案,经肌肉和皮内两种途径接种乙肝疫苗并随访7个月,以观察国产血源性乙肝疫苗的免疫效果。首次接种后7个月,肌肉组和皮内组抗-HBs应答率分别为86.7%和76.2%,抗-HBs GMT分别为115和96mIU/ml。两者差别均不显著。疫苗组和对照组HBV感染率分别为2.0%和17.6%,保护率为88.6%。疫苗接种者无严重不良反应。表明国产血源性乙肝疫苗有较好的免疫原性;在观察期间内,两种途径免疫效果相似,且安全可靠。 |
| 英文摘要: |
| Ninety and six adults who were confirmed to be negative for all HBV sero-markers were injected plasma-derived hepatitis B vaccine intramuscularly and intradermally respectively in a randomized, double blind, placebo-controlled trial. The Vaccine was injected at 0, 1,6 months and followed up for 7 months. At 7 months after the first injection, anti-HBs Sero-conversion rate in intramuscular injection group was 86.7% and intradermal grouo was 76.2%, and anti-HBs GMT were 115 and 96 mIU/ml, res-p ectively. ihere were no Significant differences either in anti-HBs seroconversion rate or anti-HBs GMT between the two groups. Infection rates of HBV in vaccineted and placebo-controlled group were 2.0 and 17.6% respectively. protective rate of vaccine was 88.6%. No serious side effects in vaccinated group were observed. |
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