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Persistence of Zika Virus in Semen After Acute Infection

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ClinicalTrials.gov Identifier: NCT02733796
Recruitment Status : Completed
First Posted : April 12, 2016
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

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.

Condition or disease
Zika Virus Zika Virus Disease Virus Shedding Transmission

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.

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Persistence of Zika Virus in Semen After Acute Infection
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Zika Virus




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Biospecimen Retention:   Samples Without DNA
sera urine semen


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733796


Locations
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Belgium
ITM
Antwerp, Belgium, 2000
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
Investigators
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Study Chair: Emmanuel Bottieau, MD PhD Institute of Tropical Medicine, Antwerp, Belgium
Additional Information:
Publications:

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Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT02733796    
Other Study ID Numbers: B300201628191
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Time Frame: within 6 months of study completion
Access Criteria: Eligible researchers will be able to request access through a access request form
Keywords provided by Institute of Tropical Medicine, Belgium:
zika virus
semen analysis
sexual transmission
Additional relevant MeSH terms:
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Virus Diseases
Zika Virus Infection
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections