Epstein-Barr Virus (EBV)NCT07536048
A Longitudinal Study of Epstein-Barr Virus (EBV) Reactivation in Adults Aged 18 to 29 Years
An observational study of Epstein-Barr Virus (EBV) and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Epstein-Barr Virus (EBV), Healthy Volunteers
- What is being tested?
- Investigational Procedure
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesAustralia
- Study dates
- 20 Apr 2026to 14 May 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Approximately 100 EBV seropositive participants aged 18 to 29 years
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Griffith - University Clinical Trial Unit - Site Number : 0360001
Gold Coast, 4222
University of Sunshine Coast - Site Number : 0360002
South Brisbane, 4101
About this study
Official 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
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).
- Conditions
- Epstein-Barr Virus (EBV), Healthy Volunteers
- Being tested
- Investigational Procedure
- Medical subject headings
- Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational ProcedureProcedure or surgery
It consists of prospective blood and saliva collections. Study without any IMP administration.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants who are EBV seropositive | Not described Receives: Procedure: Investigational Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with EBV DNA in blood and saliva at each study visit
Measured: 6 or 12 months
Serology testing indicative of EBV reactivation, measured by anti-VCA IgG/IgM, anti-EBNA-1 IgG and anti-EA IgG at each study visit
Measured: 6 or 12 months
Secondary outcomes (3)
Levels of IgG antibodies binding to EBV antigens, measured at selected time points in a subset of participants
Measured: 6 or 12 months
Levels of EBV nAbs in serum measured at selected timepoints in a subset of participants
Measured: 6 or 12 months
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
Measured: 6 or 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start20 Apr 2026
- Primary completion14 May 2027 (estimated)
- Study completion14 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epstein-Barr Virus (EBV)Studies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536048
- Sponsor's protocol ID
- VBP00004
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org