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Understanding Excretion and Infectivity of Zika Virus in Semen During and After Infection

NCT02979938 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2018-05-07

No results posted yet for this study

Summary

In this prospective observational study the investigators will report on 20 male subjects with proven WHO-classification Zika infection. These subjects will be followed up for a maximum of 12 months to observe the presence, viral load and infectivity of Zika virus (ZIKV) in semen over time.

Conditions

  • Zika Virus

Interventions

OTHER

Semen analysis and semen PCR for Zika virus

Every two weeks subjects provide a semen sample which is analysed and then frozen for RT-PCR and viral load. Semen sample testing for the presence of ZIKV (Institute of Tropical Medicine, Belgium) will be performed using both a ZIKV-specific, in-house duplex real-time RT-PCR, targeting a 102bp and 121bp sequence of the NS5 gene and the RealStar® Zika Virus RT-PCR Kit (Altona). Quantitative viral load RNA measurements will be expressed utilizing threshold cycle values because a standardized viral load reference method is not available. To test for infectivity of ZIKV in semen, ZIKV isolation will be attempted in semen samples with a high viral ZIKV load (i.e. positive ZIKV PCR result and Ct-values below 30) by inoculation in Vero cells.

Sponsors & Collaborators

  • Institute of Tropical Medicine, Belgium

    collaborator OTHER

  • Trinidad and Tobago IVF and Fertility Centre

    lead OTHER

Principal Investigators

  • Catherine Minto-Bain, MB ChB MRCOG · Trinidad & Tobago IVF & Fertility Centre

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-05-31
Completion
2017-08-31

Countries

  • Trinidad and Tobago

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02979938 on ClinicalTrials.gov