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NCT Number: NCT07536048

A Longitudinal Study of Epstein-Barr Virus (EBV) Reactivation in Adults Aged 18 to 29 Years

This multi-center, prospective, longitudinal cohort study is designed to gather immunological and clinical data on EBV reactivation in EBV seropositive adults aged 18 to 29 years.

This study will follow a cohort of approximately 100 EBV seropositive adults 18 to 29 years of age in Australia over a 6 or 12-month period.

Participants will not receive any study intervention (eg, study treatments, vaccines).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Epstein-Barr Virus (EBV) DNA Virus Infections Epstein-Barr Virus Infections Healthy Volunteers Herpesviridae Infections Infections Tumor Virus Infections Virus Diseases

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Griffith - University Clinical Trial Unit - Site Number : 0360001, Gold Coast, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 to 29 years on the day of inclusion
  • Participants who are healthy as determined by medical evaluation including medical history and physical examination
  • Participants who are EBV seropositive based on serology testing

Exclusion criteria

Any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives, including planning to leave the area of the study before the end of study period

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Investigational Procedure

Procedure

It consists of prospective blood and saliva collections. Study without any IMP administration.

Primary outcomes

  1. Number of participants with EBV DNA in blood and saliva at each study visit

    Time frame: 6 or 12 months

  2. Serology testing indicative of EBV reactivation, measured by anti-VCA IgG/IgM, anti-EBNA-1 IgG and anti-EA IgG at each study visit

    Time frame: 6 or 12 months

Secondary outcomes

  1. Levels of IgG antibodies binding to EBV antigens, measured at selected time points in a subset of participants

    Time frame: 6 or 12 months

  2. Levels of EBV nAbs in serum measured at selected timepoints in a subset of participants

    Time frame: 6 or 12 months

  3. Immunogenicity assessments at baseline to identify antibody signatures that may correlate with the occurrence of EBV reactivations during study period. Neutralizing and IgG binding assays will be performed in a subset of participants

    Time frame: 6 or 12 months

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

A Multi-center, Prospective, Longitudinal Cohort Study to Collect Immunological and Clinical Data on Epstein-Barr Virus (EBV) Reactivation in EBV Seropositive Male and Female Adults Aged 18 to 29 Years

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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