Persistence of Zika Virus in Semen After Acute Infection

NCT02733796 | Completed DMC

• 1 other identifier: B300201628191
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Zika Virus; Zika Virus Disease; Virus Shedding; Transmission

Keywords

zika virus; semen analysis; sexual transmission

Outcome Measures

Primary Outcomes (1)

• Incidence rate of ZIKV persistence in semen

  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 Outcomes (3)

• kinetics of ZIKV persistence in semen

  weekly followup (until 2 consecutive negative PCR results)- up to 6 months

• replication fitness of ZIKV in semen

  weekly followup (until 2 consecutive negative PCR results)- up to 6 months

• comparison of ZIKV sequences from semen vs. non-semen samples

  weekly followup (until 2 consecutive negative PCR results)- up to 6 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead

Study Sites (1)

ITM

Antwerp, 2000, Belgium

Location

Related Publications (8)

• Foy BD, Kobylinski KC, Chilson Foy JL, Blitvich BJ, Travassos da Rosa A, Haddow AD, Lanciotti RS, Tesh RB. Probable non-vector-borne transmission of Zika virus, Colorado, USA. Emerg Infect Dis. 2011 May;17(5):880-2. doi: 10.3201/eid1705.101939.

  PMID: 21529401 BACKGROUND

• Musso D, Roche C, Robin E, Nhan T, Teissier A, Cao-Lormeau VM. Potential sexual transmission of Zika virus. Emerg Infect Dis. 2015 Feb;21(2):359-61. doi: 10.3201/eid2102.141363.

  PMID: 25625872 BACKGROUND

• Gourinat AC, O'Connor O, Calvez E, Goarant C, Dupont-Rouzeyrol M. Detection of Zika virus in urine. Emerg Infect Dis. 2015 Jan;21(1):84-6. doi: 10.3201/eid2101.140894.

  PMID: 25530324 BACKGROUND

• Hirayama T, Mizuno Y, Takeshita N, Kotaki A, Tajima S, Omatsu T, Sano K, Kurane I, Takasaki T. Detection of dengue virus genome in urine by real-time reverse transcriptase PCR: a laboratory diagnostic method useful after disappearance of the genome in serum. J Clin Microbiol. 2012 Jun;50(6):2047-52. doi: 10.1128/JCM.06557-11. Epub 2012 Mar 21.

  PMID: 22442323 BACKGROUND

• Poloni TR, Oliveira AS, Alfonso HL, Galvao LR, Amarilla AA, Poloni DF, Figueiredo LT, Aquino VH. Detection of dengue virus in saliva and urine by real time RT-PCR. Virol J. 2010 Jan 27;7:22. doi: 10.1186/1743-422X-7-22.

  PMID: 20105295 BACKGROUND

• Korhonen EM, Huhtamo E, Virtala AM, Kantele A, Vapalahti O. Approach to non-invasive sampling in dengue diagnostics: exploring virus and NS1 antigen detection in saliva and urine of travelers with dengue. J Clin Virol. 2014 Nov;61(3):353-8. doi: 10.1016/j.jcv.2014.08.021. Epub 2014 Sep 1.

  PMID: 25242312 BACKGROUND

• Barzon L, Pacenti M, Franchin E, Pagni S, Martello T, Cattai M, Cusinato R, Palu G. Excretion of West Nile virus in urine during acute infection. J Infect Dis. 2013 Oct 1;208(7):1086-92. doi: 10.1093/infdis/jit290. Epub 2013 Jul 2.

  PMID: 23821721 BACKGROUND

• Oster AM, Brooks JT, Stryker JE, Kachur RE, Mead P, Pesik NT, Petersen LR. Interim Guidelines for Prevention of Sexual Transmission of Zika Virus - United States, 2016. MMWR Morb Mortal Wkly Rep. 2016 Feb 12;65(5):120-1. doi: 10.15585/mmwr.mm6505e1.

  PMID: 26866485 BACKGROUND

Related Links

• World Health Organization declares Public Health Emergency of International Concern

Biospecimen

Retention: SAMPLES WITHOUT DNA

sera urine semen

MeSH Terms

Conditions

Zika Virus Infection

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections

Study Officials

• Emmanuel Bottieau, MD PhD

  Institute of Tropical Medicine, Antwerp, Belgium

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 12, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: within 6 months of study completion
• Access Criteria: Eligible researchers will be able to request access through a access request form

Locations

BE (1)