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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2017

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.

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.

Clinical Trial Outcome Measures

Primary Measures

  • Measurement of the presence (with RT-PCR) of ZIKV in semen
    • Time Frame: 6 months

Secondary Measures

  • Measurement of the viral load (with ct values) of ZIKV in semen
    • Time Frame: 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • Male aged 18-50 years – ZIKV symptoms within the preceding thirty days – Confirmed ZIKV infection (WHO criteria) – Able to ejaculate to produce a semen sample Exclusion Criteria:

• Current urological malignancy

Gender Eligibility: Male

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Trinidad and Tobago IVF and Fertility Centre
  • Collaborator
    • Institute of Tropical Medicine, Belgium
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Catherine Minto-Bain, MB ChB MRCOG, Principal Investigator, Trinidad & Tobago IVF & Fertility Centre

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