b型流感嗜血杆菌结合疫苗免疫后血清抗Hib PRP IgG抗体的免疫应答
b형류감기혈간균결합역묘면역후혈청항Hib PRP IgG항체적면역응답
Immunogenicity of Hib-TT conjugate vaccine in 6-59 months-old young children and the antibody persistence in 3-5 months-old infants after primary and boosting injection with Hib-TT and Act-Hib conjugate vaccines
  • 万方数据
    中华微生物学和免疫学杂志 중화미생물학화면역학잡지
    CHINESE JOURNAL OF MICROBIOLOGY AND IMMUNOLOGY
    2012年 10期 900-905 ,共6页

    赵志强%李亚南%叶强%谭晓梅%杜送田%李荣成%李艳萍%李凤祥%谢贵林

    조지강%리아남%협강%담효매%두송전%리영성%리염평%리봉상%사귀림

    Hib结合疫苗%免疫原性%抗体几何平均浓度%基础免疫%加强免疫 Hib結閤疫苗%免疫原性%抗體幾何平均濃度%基礎免疫%加彊免疫
    Hib결합역묘%면역원성%항체궤하평균농도%기출면역%가강면역
    Hib-TT conjugate vaccine%Immunogenicity%GMC%Primary immunization%Boosting immunization
    目的 评价兰州生物制品研究所生产的Hib-TT结合疫苗的免疫原性.方法 采用随机、开放的对照研究方法,对6～59月龄儿童分别接种2或1剂实验疫苗,观察免疫后1个月时受试者血清抗Hib PRP IgG抗体几何平均浓度(GMC)和抗体浓度≥1.0 μg/ml的比例；将3～5月龄198名婴幼儿随机分为两组分别接种3剂实验疫苗或对照疫苗结合疫苗,基础免疫后1年时分别给予1剂加强免疫.观察基础免疫后1个月、1年、加强免疫后1个月和1年时血清抗Hib PRP IgG抗体GMC和抗体浓度≥1.0 μg/ml的受试者比例.结果 给6～59月龄健康受试者接种疫苗1个月后,至少有91％以上受试者血清抗Hib PRP IgG抗体浓度≥1.0 μg/ml；其中6～11月龄组2剂免疫后血清抗体GMC为14.04 μg/ml(95％ CI:12.40 ～ 15.90),所有受试者血清抗体浓度均≥1.0 μg/ml；12 ～59月龄幼儿组1剂免疫后血清抗体GMC为14.01 μg/ml(95％ CI:12.99～15.11),至少有91.30％(95％ CI:86.34 ～ 94.98)的受试者血清抗体浓度≥1.0 μg/ml.3～5月龄婴幼儿经3剂试验疫苗接种后血清抗体GMC为14.52 μg/ml (95％ CI:12.31 ～ 17.14),抗体浓度≥1.0 μg/ml的比例为96.90％ (95％ CI:92.50～ 99.20)；对照疫苗组血清抗体GMC为22.82μg/ml(95％ CI:18.44 ～28.25),抗体浓度≥1.0 μg/ml的比例为98.55％ (95％ CI:92.20～99.90).加强免疫后1个月时,实验疫苗和对照疫苗受试者血清抗体GMC分别从加强免疫前的6.27 μg/ml(95％ CI:5.28 ～7.4)和5.57 μg/ml (95％ CI:4.45 ～ 6.97)增加至加强免疫后1个月时的63.14 μg/ml(95％ CI:52.14 ～76.47)和73.48 μg/ml(95％ CI:57.37 ～94.11),血清抗体≥1.0μg/ml的受试者比例分别从与加强免疫前的76.35％ (95％ CI:68.7％ ～ 82.9％)和79.55％ (95％ CI:69.60 ～ 87.40)均上升至100％.加强免疫后1年时,虽两组血清抗Hib PRP IgG抗体虽有下降,但GMC仍分别维持在25.02 μg/ml(95％CI:20.51 ～30.48)和23.64 μg/ml(95％ CI:18.40～ 30.43)的较高浓度,两组的所有受试者血清抗体浓度均≥1.0 μg/ml.结论 实验疫苗对3～59月龄儿童能诱导产生长期保护水平的抗HibPRP IgG抗体；两种Hib结合疫苗对3～5月龄婴幼儿具有相同的免疫原性特征.
    목적 평개란주생물제품연구소생산적Hib-TT결합역묘적면역원성.방법 채용수궤、개방적대조연구방법,대6～59월령인동분별접충2혹1제실험역묘,관찰면역후1개월시수시자혈청항Hib PRP IgG항체궤하평균농도(GMC)화항체농도≥1.0 μg/ml적비례；장3～5월령198명영유인수궤분위량조분별접충3제실험역묘혹대조역묘결합역묘,기출면역후1년시분별급여1제가강면역.관찰기출면역후1개월、1년、가강면역후1개월화1년시혈청항Hib PRP IgG항체GMC화항체농도≥1.0 μg/ml적수시자비례.결과 급6～59월령건강수시자접충역묘1개월후,지소유91％이상수시자혈청항Hib PRP IgG항체농도≥1.0 μg/ml；기중6～11월령조2제면역후혈청항체GMC위14.04 μg/ml(95％ CI:12.40 ～ 15.90),소유수시자혈청항체농도균≥1.0 μg/ml；12 ～59월령유인조1제면역후혈청항체GMC위14.01 μg/ml(95％ CI:12.99～15.11),지소유91.30％(95％ CI:86.34 ～ 94.98)적수시자혈청항체농도≥1.0 μg/ml.3～5월령영유인경3제시험역묘접충후혈청항체GMC위14.52 μg/ml (95％ CI:12.31 ～ 17.14),항체농도≥1.0 μg/ml적비례위96.90％ (95％ CI:92.50～ 99.20)；대조역묘조혈청항체GMC위22.82μg/ml(95％ CI:18.44 ～28.25),항체농도≥1.0 μg/ml적비례위98.55％ (95％ CI:92.20～99.90).가강면역후1개월시,실험역묘화대조역묘수시자혈청항체GMC분별종가강면역전적6.27 μg/ml(95％ CI:5.28 ～7.4)화5.57 μg/ml (95％ CI:4.45 ～ 6.97)증가지가강면역후1개월시적63.14 μg/ml(95％ CI:52.14 ～76.47)화73.48 μg/ml(95％ CI:57.37 ～94.11),혈청항체≥1.0μg/ml적수시자비례분별종여가강면역전적76.35％ (95％ CI:68.7％ ～ 82.9％)화79.55％ (95％ CI:69.60 ～ 87.40)균상승지100％.가강면역후1년시,수량조혈청항Hib PRP IgG항체수유하강,단GMC잉분별유지재25.02 μg/ml(95％CI:20.51 ～30.48)화23.64 μg/ml(95％ CI:18.40～ 30.43)적교고농도,량조적소유수시자혈청항체농도균≥1.0 μg/ml.결론 실험역묘대3～59월령인동능유도산생장기보호수평적항HibPRP IgG항체；량충Hib결합역묘대3～5월령영유인구유상동적면역원성특정.
    Objective To evaluate the immunogenicity of a Haemophilus influenzae type b capsular-tetanus toxoid(Hib-TT) conjugate vaccine produced by Lanzhou Institute of Biological products(LIBP).Methods In an open-controlled,randomized trial,the eligible and consented 6-59 months-old young children injected 2 or 1 times 1 month apart with Hib-TT conjugate vaccine,the 3-5 months-old infants received 3 injections 1 month apart for primary immunization with Hib-TT or a licensed international Hib-TT conjugate vaccine as the control vaccine,and the boosting dose of two 3-5 months-old groups was injected at the 15-17months-old.The serum anti-Hib PRP IgG GMC in both groups after primary and boosting vaccination was measured by ELISA,the percentage of geometric mean concentration (GMC) ≥ 0.15 μg/ml and ≥ 1.0μg/ml was calculated,respectively.Results The Hib-TT conjugate vaccine produced in LIBP elicited satisfactory IgG antibody response in 3-59 months-old young children,the serum IgG GMC of anti-Hib PRP were 14.52 μg/ml(95％ CI:12.31-17.14)in 3-5 months-old,14.04 μg/ml(95％ CI:12.40-15.90) in 6-11 months-old.the ratios of IgG antibody concentration ≥ 1.0 μg/ml were 96.90％ (95％ CI:92.50-99.20) in study vaccine group and 98.55％ (95％ CI:92.20-99.90) in the control vaccine after 3 doses,respectively.100％ of the 6-11 months-old young children who injected 2 times with the Hib-TT conjugate vaccine had IgG antibody concentration ≥ 1.0 μg/ml (95％ CI:95.94-100.00),91.35％ (95％ CI:86.13-99.48) of recipients in 12-59 months-old young children induced the IgG antibody concentration ≥ 1.0 μg/ml after a single dose.The serum IgG antibody GMC in recipients who received the study or and control vaccines increased from 6.27 μg/ml (95 ％ CI:5.28-7.48) and 5.57 μg/ml (95 ％ CI:4.45-6.97)at pre-boosting injections to 63.14 μg/ml(95％ CI:52.14-76.47) and 73.48 μg/ml (95％ CI:57.37-94.11) one month after boosting injection,respectively.The percentage of IgG antibody concentration ≥ 1.0 μg/ml increased from 76.35％ and 79.55％ of pre-boosting to 100％ in the two groups after booting dose.Although the serum IgG GMC in two groups appeared to decline markedly,it remained at a relatively high levels of 25.02 μg/ml (95％ CI:20.51-30.48) in the study vaccine and 23.64 μg/ml (95％ CI:18.40-30.43) in the control vaccine,and all of the recipients in both groups remained 100.0％ of IgG antibody concentration ≥ 1.0 μg/ml.Conclusion The study vaccine elicited a protective immune response and induced the IgG antibody concentration which indicated long-term protection of anti-Hib PRP in 3 to 59months-old infants and young children.
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