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

Zika Virus Clinical Trial

— ZikaBra  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03106714
• Other study ID #: ERC.0002786
• Secondary ID: 62518016.6.1001.
• Status: Completed
• Start date: July 21, 2017
• Est. completion date: June 26, 2020

Study information

• Verified date: February 2021
• Source: Oswaldo Cruz Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: June 26, 2020
• Est. primary completion date: June 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Index Case - Enrolment 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 RT-PCR test negative for ZIKV in blood and/or urine specimens

Household contacts enrollment (or sexual contacts if index case lives alone) Inclusion criteria

• As per index case Exclusion criteria

• As per index case

Related Conditions & MeSH terms

• Zika Virus
• Zika Virus Infection

Intervention

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

Locations

Country	Name	City	State
Brazil	Tropical Medicine Foundation	Manaus	Amazonas
Brazil	Research Centre Aggeu Magalhães, Oswaldo Cruz Foundation	Recife	Pernambuco
Brazil	Evandro Chagas National Institute of Infectious Diseases - Oswaldo Cruz Foundation	Rio de Janeiro

Sponsors (6)

Lead Sponsor	Collaborator
Oswaldo Cruz Foundation	Ministry of Health, Brazil, National Institute of Allergy and Infectious Diseases (NIAID), Walter Reed Army Institute of Research (WRAIR), Wellcome Trust, World Health Organization

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Bôtto-Menezes CHA, Neto AM, Calvet GA, Kara EO, Lacerda MVG, Castilho MDC, Ströher 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 Ma — View Citation

Calvet GA, Kara EO, Giozza SP, Bôtto-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. — View Citation

Calvet GA, Kara EO, Landoulsi S, Habib N, Bôtto-Menezes CHA, Franca RFO, Neto AM, Castilho MDC, Fernandes TJ, Pereira GF, Giozza SP, Bermúdez XPD, Modjarrad K, Lima N, Brasil P, de Lacerda MVG, de Filippis AMB, Broutet NJN; ZIKABRA Study Team. Cohort prof — View Citation

Menezes-Neto A, Castilho MDC, Calvet GA, Kara EO, Bôtto-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 de — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistence and duration of ZIKV	Persistence and duration of ZIKV in each body fluid in infected symptomatic and asymptomatic participants.	12 months of follow-up after ZIKV infection diagnosis