Calvet Guilherme Amaral, Kara Edna Oliveira, Giozza Silvana Pereira, Bôtto-Menezes Camila Helena Aguiar, Gaillard Philippe, de Oliveira Franca Rafael Freitas, de Lacerda Marcus Vinicius Guimarães, da Costa Castilho Marcia, Brasil Patrícia, de Sequeira Patrícia Carvalho, de Mello Maeve Brito, Bermudez Ximena Pamela Diaz, Modjarrad Kayvon, Meurant Robyn, Landoulsi Sihem, Benzaken Adele Schwartz, de Filippis Ana Maria Bispo, Broutet Nathalie Jeanne Nicole
Acute Febrile Illnesses Laboratory, Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Rio de Janeiro, Brazil.
World Health Organization, Geneva, Switzerland.
BMC Infect Dis. 2018 Jan 22;18(1):49. doi: 10.1186/s12879-018-2965-4.
Zika virus (ZIKV) has been identified in several body fluids of infected individuals. In most cases, it remained detected in blood from few days to 1 week after the onset of symptoms, and can persist longer in urine and in semen. ZIKV infection can have dramatic consequences such as microcephaly and Guillain-Barré syndrome. ZIKV sexual transmission has been documented. A better understanding of ZIKV presence and persistence across biologic compartments is needed to devise rational measures to prevent its transmission.
This observational cohort study will recruit non-pregnant participants aged 18 years and above with confirmed ZIKV infection [positive reverse transcriptase-polymerase chain reaction (RT-PCR) test in blood and/or urine]: symptomatic men and women in ZIKV infection acute phase, and their symptomatic or asymptomatic household/sexual infected contacts. Specimens of blood, urine, semen, vaginal secretion/menstrual blood, rectal swab, oral fluids, tears, sweat, urine and breast milk (if applicable) will be collected at pre-established intervals and tested for ZIKV RNA presence by RT-PCR, other co-infection (dengue, Chikungunya, HIV, hepatitis B and C, syphilis), antibody response (including immunoglobulins M and G), plaque reduction neutralization test (if simultaneously positive for ZIKV and dengue), and ZIKV culture and RNA sequencing. Data on socio-demographic characteristics and comorbidities will be collected in parallel. Participants will be followed up for 12 months.
This prolonged longitudinal follow-up of ZIKV infected persons with regular biologic testing and data collection will offer a unique opportunity to investigate the presence and persistence of ZIKV in various biologic compartments, their clinical and immunological correlates as well as the possibility of ZIKV reactivation/reinfection over time. This valuable information will substantially contribute to the body of knowledge on ZIKV infection and serve as a base for the development of more effective recommendation on the prevention of ZIKV transmission.
NCT03106714 . Registration Date: April, 7, 2017.
寨卡病毒（ZIKV）已在感染个体的多种体液中被发现。在大多数情况下，症状出现后的数天至1周内血液中仍可检测到该病毒，而在尿液和精液中持续时间更长。寨卡病毒感染可能会导致严重后果，如小头畸形和吉兰-巴雷综合征。寨卡病毒的性传播已有文献记载。为制定合理的预防传播措施，需要更好地了解寨卡病毒在不同生物隔间中的存在情况和持续时间。
这项观察性队列研究将招募18岁及以上确诊感染寨卡病毒的非孕妇参与者[血液和/或尿液中逆转录聚合酶链反应（RT-PCR）检测呈阳性]：寨卡病毒感染急性期的有症状男性和女性，以及他们有症状或无症状的家庭/性接触感染对象。将在预定的时间间隔采集血液、尿液、精液、阴道分泌物/经血、直肠拭子、口腔液、眼泪、汗液、尿液和母乳（如适用）样本，并通过RT-PCR检测寨卡病毒RNA的存在情况，检测其他合并感染（登革热、基孔肯雅热、艾滋病毒、乙型和丙型肝炎、梅毒）、抗体反应（包括免疫球蛋白M和G）、蚀斑减少中和试验（如果寨卡病毒和登革热同时呈阳性）以及寨卡病毒培养和RNA测序。同时收集社会人口学特征和合并症的数据。参与者将接受12个月的随访。
对寨卡病毒感染者进行长期纵向随访，并定期进行生物学检测和数据收集，将提供一个独特的机会，以研究寨卡病毒在各种生物隔间中的存在情况和持续时间、其临床和免疫学相关性以及随着时间推移寨卡病毒重新激活/再次感染的可能性。这些有价值的信息将极大地丰富有关寨卡病毒感染的知识体系，并为制定更有效的寨卡病毒传播预防建议奠定基础。
NCT03106714。注册日期：2017年4月7日。
