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一种HIV-1重组金丝雀痘疫苗在感染HIV-1的妇女所生新生儿及婴儿中的安全性和免疫原性。

Safety and immunogenicity of an HIV-1 recombinant canarypox vaccine in newborns and infants of HIV-1-infected women.

作者信息

Johnson Daniel C, McFarland Elizabeth J, Muresan Petronella, Fenton Terence, McNamara James, Read Jennifer S, Hawkins Elizabeth, Bouquin Pamela L, Estep Scharla G, Tomaras Georgia D, Vincent Carol A, Rathore Mobeen, Melvin Ann J, Gurunathan Sanjay, Lambert John

机构信息

Sinai Children's Hospital and Rosalind Franklin University of Medicine and Science, North Chicago, IL 60608, USA.

出版信息

J Infect Dis. 2005 Dec 15;192(12):2129-33. doi: 10.1086/498163. Epub 2005 Nov 9.

DOI:10.1086/498163
PMID:16288378
Abstract

Pediatric AIDS Clinical Trials Group protocol 326 is a study of 2 formulations of recombinant canarypox ALVAC vaccine (vCP205) against human immunodeficiency virus type 1 (HIV-1). HIV-1-exposed infants were randomized to receive 1 of 2 formulations of vCP205 or placebo at birth and 4, 8, and 12 weeks. The vaccines were safe. Lymphoproliferative responses were detected at > or =2 time points in 44%-56% of vaccinees and none of the placebo recipients. A cytotoxic T lymphocyte response on at least 1 occasion was detected in 62.5% of infants in cohort 1 (10(6.08) median tissue culture dose [TCID(50)] vaccine formulation) and 44% of infants in cohort 2 (10(6.33) TCID(50) vaccine formulation). Rare mucosal immunoglobulin A responses and no measurable vaccine-elicited serum antibodies were detected. In children, vCP205 appeared to be safe and immunogenic.

摘要

儿科艾滋病临床试验组方案326是一项针对两种重组金丝雀痘病毒ALVAC疫苗(vCP205)预防1型人类免疫缺陷病毒(HIV-1)的研究。暴露于HIV-1的婴儿在出生时以及4周、8周和12周被随机分配接受两种vCP205制剂中的一种或安慰剂。疫苗是安全的。44%-56%的疫苗接种者在≥2个时间点检测到淋巴细胞增殖反应,而安慰剂接受者均未检测到。在队列1(10(6.08)中位组织培养剂量[TCID(50)]疫苗制剂)的62.5%婴儿和队列2(10(6.33) TCID(50)疫苗制剂)的44%婴儿中至少有一次检测到细胞毒性T淋巴细胞反应。检测到罕见的黏膜免疫球蛋白A反应,未检测到可测量的疫苗诱导血清抗体。在儿童中,vCP205似乎是安全且具有免疫原性的。

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