NCT02979938

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Trinidad and Tobago IVF and Fertility Centre · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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. Knowledge of the possible presence, infectivity and persistence of ZIKV in semen will provide evidence-based data for 1. estimating of the risk of sexual transmission of ZIKV in the general population 2. antenatal guidelines for the prevention of sexual transmission of ZIKV to the fetus 3. advising couples on the length of time that pregnancy should be avoided in women wishing to conceive after their partner's ZIKV infection 4. strategies to prevent transmission of ZIKV infection through assisted reproductive treatment (ART) 5. advice on gamete cryopreservation 6. optimising investigations for diagnosis of ZIKV in males.

Conditions

• Zika Virus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-05-01
• Completion: 2017-08-01
• First posted: 2016-12-02
• Last updated: 2018-05-07

Locations

1 site across 1 country: Trinidad and Tobago