Principal Investigator: Carrie Byington
Keywords: Zika virus , US Olymics Department: Pediatric Administration
IRB Number: 00090632 Co Investigator: Kimberly Hanson
Specialty: Infectious Diseases
Sub Specialties:
Recruitment Status: Enrolling by invitation

Contact Information

Carrie Byington
carrie.byington@hsc.utah.edu
(801) 913-8919

Brief Summary

Pilot Study

Our primary objective is to increase our understanding of the dynamics of Zika virus infection including the duration of virus in specific body fluids in order to better protect the health of athletes and staff who will participate in the 2016 Olympic Games.

Specific Aims:

  1. Administer web-based pre-travel,  post travel surveys to identify baseline history of yellow fever vaccine or previous flavivirus infection (e.g. dengue) and signs or symptoms associated with Zika virus infection
  2. Obtain and archive pre and post travel serum from healthy adults associated with  USOC participating in the spring preparatory visit for the Olympic games
    1. Test pre-and post- travel serum for Zika, dengue, West Nile and chickngunya viruses IgM and IgG
    2. Test serum, saliva, dried blood spots, urine, tear, semen, vaginal secretions and breast milk as indicated by RT-PCR for Zika RNA
  3. Administer a web-based reproductive health survey 8 weeks after travel to Brazil and a pregnancy survey for 12 months post travel in order to assess for pregnancy in female traveler or in the female partners of male travelers
    1. Women travelers or the female partners of male travelers who have identified pregnancies will be surveyed quarterly through pregnancy completion or termination to ascertain fetal/infant outcomes
  4. Obtain and archive post travel semen, saliva, tear and urine samples (monthly (± 2 weeks) ) from male travelers
    1. Test semen, saliva, tear and urine samples by RT PCR for Zika virus
  5. Obtain and archive post travel vaginal secretions, saliva, tear, urine and breast milk samples (monthly (± 2 weeks) )  from female travelers
    1. Test vaginal secretions, saliva, tear, urine and breast milk samples by RT PCR for Zika virus

Extension Study 1

Determine incidence of and risk factors for ZIKV infection in a cohort of athletes, coaches, staff, other personnel traveling to Brazil with the US Olympic Committee (USOC) as part of the 2016 Olympic and Paralympic Games and their sexual partners through antibody testing.

Extension Study 2

Determine incidence of and risk factors for ZIKV infection in adult sexual partners of Zika virus infected participants (enrolled in the Pilot Study or Extension Study 1) through antibody testing.

Extension Studies 1 and 2

  1. Determine in ZIKV infected individuals, the duration of ZIKV nucleic acid detection in specific body fluids that may be associated with sexual or perinatal transmission of the virus including blood, breast milk, saliva, tear, semen, and vaginal secretions using novel PCR technology.
  1. Compare duration of nucleic acid detection in individuals with symptomatic and asymptomatic ZIKV infection.
  2. Compare duration of nucleic acid detection in pregnant and non-pregnant individuals.
  1. Evaluate the reproductive outcomes of ZIKV infected individuals including pregnancy and infant outcomes.
  1. Evaluate effectiveness of contraceptive regimens in preventing pregnancy for recommended time periods.
  2. Compare reproductive outcomes in individuals with symptomatic and asymptomatic ZIKV infection including the ability to achieve and sustain pregnancy to term.
  3. Evaluate live infant outcomes at birth including growth parameters and presence of congenital anomalies and developmental outcomes at 12 months of age. 

Inclusion Criteria

Inclusion Criteria for the Pilot Study and Extension Study 1:

  • Adult 18 years or older
  • USOC associated adult athlete, coach, healthcare professional, staff member
  • Adult sexual partners of the USOC associated travelers
  • Travel to Brazil prior to or during the 2016 Olympic or Paralympic games
  • Signed informed consent for participation

Inclusion Criteria for Extension Study 2:

  • Adult 18 years or older
  • Have a Zika virus infected sexual partner enrolled in the Pilot Study or Extension Study 1
  • Signed informed consent for participation

 

Exclusion Criteria

Exclusion Criteria:

  • None