有症状指示病例的家庭接触者中的登革热感染：对社区干预研究的启示
Dengue Infections Among Household Contacts of Symptomatic Index Cases: Implications for Community-Based Intervention Studies.
作者信息
Koehne Erik, Van Wesenbeeck Liesbeth, Hibberd Martin L, Buelens Annemie, Toizumi Michiko, Clerck Kim De, Vijgen Leen, Lagatie Ole, Masdin Lucy, Nguyen Hien Anh Thi, Le Hoang Huy, Dang Duc Anh, Huynh Mai Kim, Le Lien Thuy, Nguyên Trieu Bao, Hue Stephane, Do Hung Thai, Herrera-Taracena Guillermo, Rasschaert Freya, Yoshida Lay-Myint
机构信息
Department of Pediatric Infectious Diseases, Institute of Tropical Medicine, Nagasaki University, Nagasaki 852-8523, Japan.
Johnson & Johnson, 2340 Beerse, Belgium.
出版信息
Viruses. 2025 Jun 17;17(6):859. doi: 10.3390/v17060859.
BACKGROUND
Dengue is a global health concern, with half of the world's population at risk and no antiviral treatment available. This Phase 0 study investigated dengue infections among household contacts (HHCs) of dengue index cases (ICs) and assessed the feasibility of conducting a Phase 2 trial for a novel antiviral.
METHODS
Participants were enrolled in Nha Trang, Vietnam, from April 2022 to February 2023. Dengue ICs were identified within 72 h of fever onset, and their healthy adult HHCs enrolled within 48 h. Blood samples and questionnaires were collected bi-weekly for four weeks, with a follow-up visit on day 40. DENV RT-qPCR, NS1, and anti-DENV IgM/IgG ELISAs were performed.
RESULTS
Overall, 130 dengue ICs and 301 HHCs were enrolled, with 91.7% (276/301) completing all follow-up visits. Baseline anti-DENV IgG showed prior dengue infections in 262/301 HHCs (87.0%). Fifty HHCs were excluded from the HHC infection analysis based on evidence of a DENV infection (viral load [VL], NS1, IgM, and IgG results) at enrollment. During follow-up, 2.0% of HHCs (5/251) had DENV infections based on virological parameters (DENV RNA and/or NS1 positivity), and anti-DENV IgG/IgM seroconversion was detected in 7.2% (18/251).
CONCLUSIONS
This study demonstrated the operational feasibility of a dengue IC-HHC design for a Phase 2 trial.
背景
登革热是一个全球卫生问题，全球一半人口面临风险且尚无抗病毒治疗方法。这项0期研究调查了登革热指示病例（IC）的家庭接触者（HHC）中的登革热感染情况，并评估了开展一种新型抗病毒药物2期试验的可行性。
方法
2022年4月至2023年2月在越南芽庄招募参与者。在发热开始后72小时内确定登革热IC，其健康成年HHC在48小时内登记入组。每两周采集一次血样和问卷，持续四周，并在第40天进行随访。进行登革病毒逆转录定量聚合酶链反应（DENV RT-qPCR）、非结构蛋白1（NS1）和抗登革病毒免疫球蛋白M/免疫球蛋白G（IgM/IgG）酶联免疫吸附测定（ELISA）。
结果
总体而言，共招募了130例登革热IC和301例HHC，其中91.7%（276/301）完成了所有随访。基线抗登革病毒IgG显示262/301例HHC（87.0%）既往有登革热感染。根据入组时登革病毒感染（病毒载量[VL]、NS1、IgM和IgG结果）的证据，50例HHC被排除在HHC感染分析之外。在随访期间，基于病毒学参数（登革病毒RNA和/或NS1阳性），2.0%的HHC（5/251）发生了登革病毒感染，7.2%（18/251）检测到抗登革病毒IgG/IgM血清学转换。
结论
本研究证明了登革热IC-HHC设计用于2期试验的操作可行性。
Zotero 插件