Study on the Persistence of Zika Virus (ZIKV) in Body Fluids of Patients With ZIKV Infection in Brazil

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-21

Study Completion Date

2020-06-26

Brief Summary

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The Zika infection is a viral disease that is transmitted to humans by the same mosquito that transmits Dengue and Chikungunya fever. The Zika virus has been found in various body fluids such as urine, blood and semen, but we do not know how long it persists in these fluids. For example, parts of the virus were reported to persist in semen after six months of the onset of symptoms, but we do not know if the virus can stay longer. In this way, we want to investigate how long the Zika virus can be found in other secretions besides blood and urine.

Study Hypothesis: ZIKV can be shed in human body fluids long after the time of the acute infection. Persistence of ZIKV in different body fluids may vary due to the influence of circulating specific ZIKV IgM and IgG, as well as host and environmental factors.

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Detailed Description

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Little is known about Zika virus (ZIKV) biology and its pathogenesis in humans. ZIKV has been detected in blood, urine, semen, cerebral spinal fluid, saliva, amniotic fluid, and breast milk. In most ZIKV infected individuals, the virus is detected in the blood from a several days to one week after the onset of symptoms and has also been found to persist longer in urine and semen. Without a more granular understanding of the kinetics of ZIKV infection across biologic compartments it will be difficult to devise rational measures to prevent the transmission of the virus.

This will be an observational cohort study of men and women, aged 18 years and above, including symptomatic participants with positive reverse transcriptase-polymerase chain reaction (RT-PCR) test in blood and/or urine and their symptomatic or asymptomatic household/sexual contacts with positive RT-PCR in blood and/or urine. Specimens to be collected at pre-established intervals and tested for ZIKV RNA by RT-PCR are blood, semen, vaginal secretions, oral fluid (saliva and crevicular fluid), tears, sweat, urine, rectal swab, menstrual blood and breast milk (if applicable). Participants will be recruited from collaborating clinics in selected locations with high population density, high circulation of the virus, strong community network, and serviced by laboratory facilities with capacity to perform the necessary tests.

All participants will be followed up for 12 months, to assess detectability at longer time intervals, reactivation or reinfection. Analyses of antibody response, including circulating immunoglobulins M and G (IgM and IgG), will be performed in parallel to RT-PCR tests. Plaque reduction neutralization test will be performed in specimens of participants who are found to be simultaneously positive for ZIKV and dengue.

Specific analysis will be performed to determine if socio-demographic characteristics, comorbidities and co-infections influence the persistence of the virus in the body fluids.

Conditions

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Zika Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Detectable RT-PCR ZIKV

Men and women aged 18 years and above with diagnosis of ZIKV infection

RT-PCR

Intervention Type DIAGNOSTIC_TEST

Persistence of detectable Zika virus (by RT-PCR test) in all selected body fluids

Interventions

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RT-PCR

Persistence of detectable Zika virus (by RT-PCR test) in all selected body fluids

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* RT-PCR test positive for ZIKV in blood and/or urine specimens
* Having given consent to provide all body fluid collection, as per protocol

Exclusion Criteria

* As per index case

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Guilherme Amaral Calvet

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nathalie JN Broutet, MD, PhD

Role: STUDY_CHAIR

Department of Reproductive Health and Research World Health Organization

Ana Maria B de Filippis, PhD

Role: PRINCIPAL_INVESTIGATOR

Oswaldo Cruz Foundation (Flavivirus Diagnostic and Reference Laboratory- Rio de Janeiro)

Guilherme A Calvet, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Oswaldo Cruz Foundation (Evandro Chagas National Institute of Infectious Diseases- Rio de Janeiro)

Rafael FO França, PhD

Role: PRINCIPAL_INVESTIGATOR

Oswaldo Cruz Foundation (Research Centre Aggeu Magalhães- Recife)

Marcus VG Lacerda, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Tropical Medicine Foundation, Manaus

Locations

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Tropical Medicine Foundation

Manaus, Amazonas, Brazil

Site Status

Research Centre Aggeu Magalhães, Oswaldo Cruz Foundation

Recife, Pernambuco, Brazil

Site Status

Evandro Chagas National Institute of Infectious Diseases - Oswaldo Cruz Foundation

Rio de Janeiro, , Brazil

Site Status

Countries

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Brazil

References

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Calvet GA, Kara EO, Giozza SP, Botto-Menezes CHA, Gaillard P, de Oliveira Franca RF, de Lacerda MVG, da Costa Castilho M, Brasil P, de Sequeira PC, de Mello MB, Bermudez XPD, Modjarrad K, Meurant R, Landoulsi S, Benzaken AS, de Filippis AMB, Broutet NJN; ZIKABRA Study Team. Study on the persistence of Zika virus (ZIKV) in body fluids of patients with ZIKV infection in Brazil. BMC Infect Dis. 2018 Jan 22;18(1):49. doi: 10.1186/s12879-018-2965-4.

Reference Type BACKGROUND

PMID: 29357841 (View on PubMed)

Menezes-Neto A, Castilho MDC, Calvet GA, Kara EO, Botto-Menezes CHA, Lacerda MVG, Pereira GFM, Giozza SP, Bermudez XPD, Lima NS, Modjarrad K, Broutet N, de Filippis AMB, Franca RFO; Study Team ZIKABRA. Zika virus RNA excretion in sweat with concomitant detection in other body fluid specimens. Mem Inst Oswaldo Cruz. 2021 Jan 25;115:e200339. doi: 10.1590/0074-02760200339. eCollection 2021.

Reference Type RESULT

PMID: 33503145 (View on PubMed)

Calvet GA, Kara EO, Landoulsi S, Habib N, Botto-Menezes CHA, Franca RFO, Neto AM, Castilho MDC, Fernandes TJ, Pereira GF, Giozza SP, Bermudez XPD, Modjarrad K, Lima N, Brasil P, de Lacerda MVG, de Filippis AMB, Broutet NJN; ZIKABRA Study Team. Cohort profile: Study on Zika virus infection in Brazil (ZIKABRA study). PLoS One. 2021 Jan 5;16(1):e0244981. doi: 10.1371/journal.pone.0244981. eCollection 2021.

Reference Type RESULT

PMID: 33400705 (View on PubMed)

Botto-Menezes CHA, Neto AM, Calvet GA, Kara EO, Lacerda MVG, Castilho MDC, Stroher U, Antunes de Brito CA, Modjarrad K, Broutet N, Brasil P, Bispo de Filippis AM, Franca RFO; ZIKABRA Study Team. Zika Virus in Rectal Swab Samples. Emerg Infect Dis. 2019 May;25(5):951-954. doi: 10.3201/eid2505.180904.

Reference Type RESULT

PMID: 31002058 (View on PubMed)