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Assessing the feasibility of hepatitis C virus vaccine trials: results from the Hepatitis C Incidence and Transmission Study-community (HITS-c) vaccine preparedness study

机译：评估丙型肝炎病毒疫苗试验的可行性：丙型肝炎发病率和传播研究社区（HITS-c）疫苗准备研究的结果

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Efficacy trials of preventive hepatitis C virus (HCV) vaccine candidates raise challenging scientific and ethical issues. Based on data from the first 3 years of a community-based prospective observational study - the Hepatitis C Incidence and Transmission Study-community (HITS-c) - this paper examines the feasibility of conducting trials of candidate HCV vaccines with people who inject drugs (PWID) in Sydney, Australia. Of the 166 PWID confirmed HCV antibody negative and eligible for enrolment, 156 (94%) completed baseline procedures. Retention was high, with 89% of participants retained at 48 weeks and 76% of participants completing at least 75% of study visits within 2 weeks of schedule. The rate of primary HCV infection was 7.9/100 py (95% CI 4.9, 12.7). Of the 17 incident cases, 16 completed at least one follow-up assessment and 12 (75%) had evidence of chronic viraemia with progression to chronic HCV infection estimated to be 6/100 py. Power calculations suggest a chronic HCV infection rate of at least 12/100 py (primary HCV infection rate 16/100 py) will be required for stand-alone trials of highly efficacious candidates designed to prevent chronic infection. However, elevated primary HCV infection was observed among participants not receiving opioid substitution therapy who reported heroin as the main drug injected (26.9/100 py, 95% CI 14.5, 50.0) and those who reported unstable housing (23.5/100 py, 95% CI 7.6, 72.8), daily or more frequent injecting (22.7/100 py, 95% CI 12.2, 42.2) and receptive syringe sharing (23.6/100 py, 95% CI 9.8, 56.7) in the 6 months prior to baseline. These data suggest that it is possible to recruit and retain at-risk PWID who adhere to study protocols and that modification of eligibility criteria may identify populations with sufficiently high HCV incidence. Results support the feasibility of large multi-centre HCV vaccine trials, including in the Australian setting
机译：预防性丙型肝炎病毒（HCV）疫苗候选者的功效试验提出了具有挑战性的科学和道德问题。基于基于社区的前瞻性观察研究的前三年数据-丙型肝炎发病率和传播研究社区（HITS-c）-本文研究了与注射药物的人进行候选HCV疫苗试验的可行性（ PWID）在澳大利亚悉尼。在166个PWID确诊的HCV抗体阴性且符合入组条件的患者中，有156个（94％）完成了基线程序。保留率很高，有89％的参与者在48周内被保留，而76％的参与者在计划的2周内完成了至少75％的研究访问。最初的HCV感染率为7.9 / 100 py（95％CI 4.9，12.7）。在这17例事件中，有16例至少完成了一项随访评估，其中12例（75％）有慢性病毒血症的证据，并发展为慢性HCV感染，估计为6/100 py。功效计算表明，对于旨在预防慢性感染的高效候选药物的独立试验，至少需要慢性HCV感染率为12/100 py（主要HCV感染率为16/100 py）。然而，在未接受阿片类药物替代治疗的参与者中，以注射海洛因为主要药物（26.9 / 100 py，95％CI 14.5，50.0）和报告住房不稳定（23.5 / 100 py，95％）的参与者中观察到原发性HCV感染升高。 CI 7.6、72.8），基线前6个月每天或更频繁的注射（22.7 / 100 py，95％CI 12.2，42.2）和接受注射器共享（23.6 / 100 py，95％CI 9.8，56.7）。这些数据表明，有可能招募和留住遵循研究方案的高危PWID，并且对资格标准的修改可以识别出具有足够高HCV发生率的人群。结果支持大型多中心HCV疫苗试验的可行性，包括在澳大利亚进行的试验

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