Safety and reactogenicity of BCG revaccination with isoniazid pretreatment in TST positive adults.
Safety and reactogenicity of BCG revaccination with isoniazid pretreatment in TST positive adults.
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DOI：
10.1016/j.vaccine.2014.04.084
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发表时间：
2014-06-30
期刊：
影响因子：
5.5
通讯作者：
Johnson, John L.
中科院分区：
文献类型：
--
作者：
Hatherill, Mark;Geldenhuys, Hendrik;Pienaar, Bernadette;Suliman, Sara;Chheng, Phalkun;Debanne, Sara M.;Hoft, Daniel F.;Boom, W. Henry;Hanekom, Willem A.;Johnson, John L.
全球结核病（TB）控制可能需要大规模接种新的TB疫苗，如重组卡介苗（BCG）或减毒结核分枝杆菌（MTB）。分枝杆菌活疫苗在既往接种过卡介苗的潜伏感染成人中的安全性尚不清楚。评估潜伏性结核分枝杆菌感染（LTBI）成人中卡介苗复种（有或无异烟肼（INH）预处理）的安全性和反应原性。82名健康、未感染HIV的南非成年人，BCG疤痕和结核菌素皮肤试验（TST）直径≥ 15 mm，随机接受6个月的INH，在BCG疫苗SSI（Statens Serum Institut，Copenhagen）皮内再接种之前或之后6个月开始。报告了BCG再接种后3个月内的安全性和反应原性数据。治疗组之间的基线特征相似。平均基线TST直径为20 ± 4 mm。72名受试者接受了卡介苗复种。注射部位红斑（68%）和硬结（86%）在再接种后1周达到峰值。溃疡（76%）在2周时达到峰值，除3例受试者外，所有受试者均在3个月时消退。溃疡直径>10mm者仅占8%，但有瘢痕残留者占85%。未观察到与BCG相关的区域淋巴结炎或严重发病率。反应原性不受INH预处理的影响。结核分枝杆菌感染成人的卡介苗再接种是安全的，耐受性良好，反应原性与初次卡介苗接种相似。可以考虑在潜伏感染的成人中进行活重组BCG或减毒MTB疫苗的临床试验，有或没有INH预处理（ClinicalTrials.gov标识符：NCT 01119521）。
Global tuberculosis (TB) control may require mass vaccination with a new TB vaccine, such as a recombinant bacille Calmette Guerin (BCG) or attenuated Mycobacterium tuberculosis (MTB). The safety profile of live mycobacterial vaccines in latently infected adults with prior infant BCG vaccination is unknown. Evaluate safety and reactogenicity of BCG revaccination, with or without isoniazid (INH) pretreatment, in adults with latent MTB infection (LTBI). Eighty-two healthy, HIV uninfected, South African adults, with a BCG scar and tuberculin skin test (TST) diameter ≥15mm, were randomized to receive 6 months of INH, starting either before, or 6 months after, intradermal revaccination with BCG Vaccine SSI (Statens Serum Institut, Copenhagen). Safety and reactogenicity data are reported through 3 months post BCG revaccination. Baseline characteristics were similar between treatment arms. Mean baseline TST diameter was 20 ± 4mm. Seventy-two subjects received BCG revaccination. Injection site erythema (68%) and induration (86%) peaked 1 week after revaccination. Ulceration (76%) peaked at 2 weeks, and resolved by 3 months in all but 3 subjects. Diameter of ulceration was >10mm in only 8%, but a residual scar was common (85%). No regional lymphadenitis or serious morbidity related to BCG was seen. Reactogenicity was not affected by INH pretreatment. BCG revaccination of MTB infected adults is safe, well tolerated, and reactogenicity is similar to that of primary BCG vaccination. Clinical trials of live recombinant BCG or attenuated MTB vaccines may be considered in latently infected adults, with or without INH pretreatment (ClinicalTrials.gov identifier: NCT01119521).
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影响因子：
3.7
作者：
Mahomed H;Hawkridge T;Verver S;Abrahams D;Geiter L;Hatherill M;Ehrlich R;Hanekom WA;Hussey GD
通讯作者：
Hussey GD
影响因子：
11.8
作者：
FitzGerald, JM
通讯作者：
FitzGerald, JM
影响因子：
9.6
作者：
Johnson, John L.;Geldenhuys, Hendrik;Hatherill, Mark
通讯作者：
Hatherill, Mark
影响因子：
168.9
作者：
Fine, PEM;Ponnighaus, JM;Peto, R
通讯作者：
Peto, R
影响因子：
6.4
作者：
Brooks-Pollock, Ellen;Becerra, Mercedes C.;Murray, Megan B.
通讯作者：
Murray, Megan B.