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
|Condition or disease|
|Zika Virus Zika Virus Disease Virus Shedding Transmission|
- To assess the duration of persistence of zika virus (ZIKV) in semen samples by means of RT-PCR, after acute ZIKV infection.
- 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|
|Actual Enrollment :||15 participants|
|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|
- 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
- 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
Biospecimen Retention: Samples Without DNA
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
|Antwerp, Belgium, 2000|
|Study Chair:||Emmanuel Bottieau, MD PhD||Institute of Tropical Medicine, Antwerp, Belgium|