Johnson & Johnson Global Public Health Research and Development, Beerse, Belgium.
Janssen Vaccines and Prevention B.V., Leiden, the Netherlands.
J Infect Dis. 2024 Jun 14;229(6):1919-1925. doi: 10.1093/infdis/jiae113.
Current serologic tests for HIV screening and confirmation of infection present challenges to the adoption of HIV vaccines. The detection of vaccine-induced HIV-1 antibodies in the absence of HIV-1 infection, referred to as vaccine-induced seropositivity/seroreactivity, confounds the interpretation of test results, causing misclassification of HIV-1 status with potential affiliated stigmatization. For HIV vaccines to be widely adopted with high community confidence and uptake, tests are needed that are agnostic to the vaccination status of tested individuals (ie, positive only for true HIV-1 infection). Successful development and deployment of such tests will require HIV vaccine developers to work in concert with diagnostic developers. Such tests will need to match today's high-performance standards (accuracy, cost-effectiveness, simplicity) for use in vaccinated and unvaccinated populations, especially in low- and middle-income countries with high HIV burden. Herein, we discuss the challenges and strategies for developing modified serologic HIV tests for concurrent deployment with HIV vaccines.
当前用于 HIV 筛查和感染确认的血清学检测方法给 HIV 疫苗的应用带来了挑战。在没有 HIV-1 感染的情况下，检测到疫苗诱导的 HIV-1 抗体，被称为疫苗诱导的血清阳性/血清反应性，这混淆了检测结果的解释，导致 HIV-1 状态的错误分类，并可能带来潜在的污名化。为了让 HIV 疫苗在社区中得到广泛接受和采用，需要开发出对检测个体的疫苗接种状态不具有偏见的检测方法（即仅对真正的 HIV-1 感染呈阳性）。成功开发和部署此类检测方法需要 HIV 疫苗开发商与诊断开发商协同工作。此类检测方法需要满足当今在接种和未接种人群中使用的高性能标准（准确性、成本效益、简单性），特别是在 HIV 负担高的中低收入国家。本文中，我们讨论了开发改良的血清学 HIV 检测方法以与 HIV 疫苗同时部署的挑战和策略。
