Prospective cohort study to describe the natural history of Epstein-Barr virus infection

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Evaluation of patient-reported outcomes

  Method development or testing
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Epstein-Barr virus infection

Population studied

• Short description of the study population:
  High school students aged 14-17 and university first-year students aged 18-20 in the U.S., Canada, Denmark, Japan, and Australia.; ; Key Inclusion Criteria include:; High school student population: Has at least one academic year of school remaining and is aged 14-17 years; University student population: Is a first-year university student aged 18-20 years; ; At Follow-up:; Meets all screening inclusion criteria and is EBV-seronegative at screening ; Has at-home access to an internet-connected device that they could use daily for 2 weeks; ; Key Exclusion Criteria include:; Has abnormalities of the spleen or a history of splenectomy (by self-report); Is receiving immunosuppressive drugs or therapy, including but not limited to chemotherapeutic agents used to treat cancer or other conditions (for example, autoimmune disease) and interventions associated with organ or bone marrow transplantation (by self-report); Regularly receives courses of daily systemic corticosteroids (equivalent of daily dose of prednisone or ≥20 mg/d) (by self-report); Has a known acquired or congenital condition that affects the immune system and/or the ability to fight infections (by self-report); Received immunoglobulins and/or any blood products in the 2 months before enrollment or are expected to receive such products in the future (by self-report); Previously received an experimental EBV vaccine
• Age groups:
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 65 years)

    • Adults (18 to < 46 years)
• Estimated number of subjects:
  4450

Study design details

• Study design:
  This is a prospective cohort study.
• Main study objective:
  The primary objectives of the study are to estimate EBV seroprevalence by study site at screening and, among participants who are seronegative at screening, estimate the incidence of (1) EBV seroconversion and (2) infectious mononucleosis (IM) during follow-up by study site.
• Setting:
  High school students aged 14-17 and university first-year students aged 18-20 in the U.S., Canada, Denmark, Japan, and Australia.
• Outcomes:
  The outcomes for this study are EBV serostatus at screening, EBV seroconversion and infectious mononucleosis.
• Data analysis plan:
  EBV seroprevalence will be calculated as the number of EBV-seropositive persons out of the total number with a valid EBV serology result obtained from a screening visit sample, stratified by site.; For each primary objective outcome, cumulative incidence will be calculated using Kaplan-Meier methods. The incidence rate will be calculated as the number of incident outcomes divided by the amount of person-time at risk of developing the outcome.;