Persistence of Zika Virus in Semen After Acute Infection

March 1, 2021 updated by: Institute of Tropical Medicine, Belgium
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.

Study Overview

Status

Completed

Conditions

Detailed Description

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 of sexual transmission of ZIKV infection in the post-viremic phase in non-epidemic settings. This evidence will contribute to a more rational advice on preventing sexual transmission of ZIKV infection.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2000
        • ITM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

men of 18 years or older, with confirmed ZIKV infection, residing in areas without epidemiologically important arthropod-borne ZIKV transmission

Description

Inclusion Criteria:

  • Male sex
  • Age 18 years or older

  • Confirmed ZIKV case, defined as:

    • Having traveled to an affected area and developing at least 2 of the following Zika virus disease compatible symptoms within 2 weeks of travel: fever defined as T≥ 37.8°C (axillary measurement), maculopapular rash, arthralgia or non-purulent conjunctivitis.
    • Zika virus diagnosis by:RNA detection by RT-PCR in serum or urine during the first 10 days after infection, OR Four-fold or greater change in virus-specific quantitative antibody titers in paired sera, OR Virus-specific Immunoglobulin M (IgM) antibodies in serum with confirmatory virus-specific neutralizing antibodies in the same or a later specimen

Exclusion Criteria:

  • History of, or ongoing urologic malignancy or urologic surgical treatment (including vasectomy).
  • Recent (< 2 years) history of, or ongoing urinary tract infection (including prostatitis, epididymitis, sexually transmitted diseases).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
weekly followup (until 2 consecutive negative PCR results)- up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
weekly followup (until 2 consecutive negative PCR results)- up to 6 months
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
weekly followup (until 2 consecutive negative PCR results)- up to 6 months
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
weekly followup (until 2 consecutive negative PCR results)- up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Tropical Medicine, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2016

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (ESTIMATE)

April 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B300201628191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes, de-identified individual participant data will be made available for all primary and secondary study outcomes within 6 months of study completion

IPD Sharing Time Frame

within 6 months of study completion

IPD Sharing Access Criteria

Eligible researchers will be able to request access through a access request form

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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