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一项针对健康成年志愿者的重组病毒样颗粒疫苗预防11型人乳头瘤病毒的1期研究。

A Phase 1 study of a recombinant viruslike particle vaccine against human papillomavirus type 11 in healthy adult volunteers.

作者信息

Evans T G, Bonnez W, Rose R C, Koenig S, Demeter L, Suzich J A, O'Brien D, Campbell M, White W I, Balsley J, Reichman R C

机构信息

Infectious Diseases Unit, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.

出版信息

J Infect Dis. 2001 May 15;183(10):1485-93. doi: 10.1086/320190. Epub 2001 Apr 24.

DOI:10.1086/320190
PMID:11319684
Abstract

Viruslike particles (VLPs) produced from the L1 protein of several papillomaviruses have induced protection from infection after live challenge in animal models. In the present study, the safety and immunogenicity of a human papillomavirus (HPV)--11 L1 VLP candidate vaccine were measured in a phase 1, dose-finding trial in humans. The vaccine was well tolerated and induced high levels of both binding and neutralizing antibodies. Marked increases in lymphoproliferation to HPV--11 L1 antigens were noted after the second vaccination. In addition, lymphoproliferation was induced after vaccination in peripheral blood mononuclear cells (PBMC) stimulated with heterologous L1 VLP antigens of HPV types 6 and 16. Statistically significant increases in HPV antigen--specific interferon--gamma and interleukin-5 production were measured from PBMC culture supernatants. This candidate HPV VLP vaccine induced robust B and T cell responses, and T cell helper epitopes appear to be conserved across HPV types.

摘要

几种乳头瘤病毒的L1蛋白产生的病毒样颗粒(VLPs)在动物模型中经活病毒攻击后可诱导产生抗感染保护作用。在本研究中,在一项1期人体剂量探索试验中测定了一种人乳头瘤病毒(HPV)-11 L1 VLP候选疫苗的安全性和免疫原性。该疫苗耐受性良好,可诱导产生高水平的结合抗体和中和抗体。第二次接种后,观察到对HPV-11 L1抗原的淋巴细胞增殖显著增加。此外,在用HPV 6型和16型异源L1 VLP抗原刺激的外周血单核细胞(PBMC)中,接种疫苗后可诱导淋巴细胞增殖。从PBMC培养上清液中检测到HPV抗原特异性干扰素-γ和白细胞介素-5产生的统计学显著增加。这种候选HPV VLP疫苗可诱导强烈的B细胞和T细胞反应,并且T细胞辅助表位在各HPV型别间似乎具有保守性。

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