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对感染艾滋病毒儿童进行皮内注射母牛分枝杆菌或皮内注射乙型肝炎疫苗的随机试验。

Randomised trial of intradermal Mycobacterium vaccae or intradermal hepatitis B immunisation in children with HIV infection.

作者信息

Johnson D, Waddell R D, Pelton S I, Jaeger A S, Modlin J F, Yogev R, Morin P, Arbeit R D, von Reyn C F

机构信息

Section of Paediatric Infectious Diseases, University of Chicago Children's Hospital, IL, USA.

出版信息

Vaccine. 1999 Jun 4;17(20-21):2583-7. doi: 10.1016/s0264-410x(99)00055-9.

DOI:10.1016/s0264-410x(99)00055-9
PMID:10418906
Abstract

This study assessed the safety of inactivated Mycobacterium vaccae as a candidate vaccine to prevent disseminated mycobacterial disease in children with HIV infection. 35 children ages 1-8 with CD4 counts > or =300/mm3 in New Hampshire, Boston and Chicago were randomised in a 2:1 schedule to receive a 3-dose series of intradermal M. vaccae vaccine (MV) or hepatitis B vaccine (HBV) at 2-month intervals. Immunisation was safe and well tolerated; 2-day median vaccine site in duration was 5 mm in MV recipients and 0 mm in HBV recipients (p < 0.001). There were no significantly different changes in viral load or CD4 count between the two vaccine groups. No PPD skin test conversions occurred after immunisation. MV is safe and well tolerated and deserves further evaluation as a vaccine to prevent mycobacterial disease in HIV-infected children.

摘要

本研究评估了灭活的母牛分枝杆菌作为候选疫苗预防HIV感染儿童播散性分枝杆菌病的安全性。新罕布什尔州、波士顿和芝加哥的35名年龄在1至8岁、CD4计数≥300/mm³的儿童,按照2:1的比例随机分组,每2个月接受3剂皮内注射的母牛分枝杆菌疫苗(MV)或乙型肝炎疫苗(HBV)。免疫接种安全且耐受性良好;MV接种者疫苗接种部位持续时间的中位数为2天,大小为5毫米,HBV接种者为0毫米(p<0.001)。两组疫苗接种组之间的病毒载量或CD4计数没有显著差异。免疫接种后未发生PPD皮肤试验阳转。MV安全且耐受性良好,作为预防HIV感染儿童分枝杆菌病的疫苗值得进一步评估。

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