Clinical Trial: Persistence of Zika Virus in Semen After Acute Infection

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Persistence of Zika Virus in Semen After Acute Infection

Brief Summary: This is a prospective observational laboratory evaluation of the persistence rate of zika virus (ZIKV) infection in semen by real-time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), and assessment of ZIKV replication-competence in semen by isolation of ZIKV. Evaluation of the persistence of ZIKV and its replication-competence in semen samples will increase the understanding of the risk of sexual transmission of ZIKV infection in the post-viremic phase in non-epidemic settings.

Detailed Summary:

Objectives

  1. To assess the duration of persistence of zika virus (ZIKV) in semen samples by means of RT-PCR, after acute ZIKV infection.
  2. To assess replication fitness of ZIKV in semen, by isolation of ZIKV virions in culture.

Study design, population, materials and methods: Prospective cohort study of persistence of zika virus (ZIKV) in semen samples of adult male patients who attend the outpatient clinic of the Institute of Tropical Medicine in Antwerp and who have a confirmed ZIKV infection (positive RT-PCR for ZIKV in a serum or urine sample at the time of inclusion). Clinical and epidemiological data will be recorded in a standardized Case Record Form (CRF). Baseline serum, blood and urine samples will be collected as required for routine clinical evaluation of an individual case and for arbovirus antibody detection assays; sampling of serum and urine collection for RT-PCR will be scheduled weekly until 2 consecutive semen samples test negative in ZIKV RT-PCR. ZIKV isolation will be attempted from each available semen sample with a positive PCR result. The semen analyses will include: sperm count, morphology, motility, leukocyte and erythrocyte count and pH of the semen. Serum at 4 weeks will be collected for ZIKV antibody detection assay.

Sample size : panel of 20 ZIKV confirmed cases Endpoints: Proportion of ZIKV positive RT-PCR on semen samples over time after confirmation of acute ZIKV infection, positivity rates of ZIKV isolation from semen samples over time after acute ZIKV infection.

Expected results and relevance : Evaluation of the persistence of ZIKV and its replication-competence in semen samples will increase the understanding of the risk
Sponsor: Institute of Tropical Medicine, Belgium

Current Primary Outcome: Incidence rate of ZIKV persistence in semen [ Time Frame: weekly followup (until 2 consecutive negative PCR results)- up to 6 months ]

proportion of ZIKV positive semen samples in adult male patients after acute ZIKV infection over time


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • kinetics of ZIKV persistence in semen [ Time Frame: weekly followup (until 2 consecutive negative PCR results)- up to 6 months ]
    kinetics of ZIKV in semen samples by means of RT-PCR Cycle threshold (Ct-value) results after acute ZIKV infection over time
  • replication fitness of ZIKV in semen [ Time Frame: weekly followup (until 2 consecutive negative PCR results)- up to 6 months ]
    assess replication fitness of ZIKV in semen, by isolation
  • comparison of ZIKV sequences from semen vs. non-semen samples [ Time Frame: weekly followup (until 2 consecutive negative PCR results)- up to 6 months ]
    comparison of ZIKV sequences of virus isolated from semen vs. non-semen samples to detect potential compartmentalization


Original Secondary Outcome: Same as current

Information By: Institute of Tropical Medicine, Belgium

Dates:
Date Received: March 30, 2016
Date Started: March 2016
Date Completion: January 2017
Last Updated: September 9, 2016
Last Verified: September 2016