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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07536048
- Acronym / sponsor ID
- VBP00004
- Conditions
- Epstein-Barr Virus (EBV), Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 14 May 2027 (estimated)
- Study completion
- 14 May 2027 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy participants who are EBV seropositive | – | Procedure: Investigational Procedure |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Approximately 100 EBV seropositive participants aged 18 to 29 years
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational ProcedureIt consists of prospective blood and saliva collections. Study without any IMP administration. | Procedure or surgery | Healthy participants who are EBV seropositive |
Primary outcome
Number of participants with EBV DNA in blood and saliva at each study visit
Time frame: 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
Time frame: 6 or 12 months
3 secondary outcomes
Levels of IgG antibodies binding to EBV antigens, measured at selected time points in a subset of participants
Time frame: 6 or 12 months
Levels of EBV nAbs in serum measured at selected timepoints in a subset of participants
Time frame: 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
Time frame: 6 or 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epstein-Barr Virus (EBV) and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with EBV DNA in blood and saliva at each study visit (time frame: 6 or 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.