The DELTA-EBV study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Helse Bergen HF

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Decision date (initial)

2026-05-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Gilead Sciences

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

The main objective of the study is to determine the safety and tolerability of a sequential dose escalation regimen of TAF (25mg, 50mg, and 100mg) in healthy individuals

Secondary objectives 1

1. The secondary objectives are to determine the effect of TAF on oral viral shedding, Epstein-Barr virus-specific CD4 T cell responses by ELISPOT, change in IgG antibodies in healthy individuals and to further assess the safety and tolerability of TAF during the treatment period.

Conditions and MedDRA coding

Epstein-Barr virus infection

Study design 1 period

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Age ≥ 18 to ≤ 65 years, both male and female participants.
2. Positive serological testing for EBNA1 or VCA IgG.
3. Creatinine clearance (CrCL) >= 80 mL/min.
4. EBV-positive otherwise healthy individuals
5. Women of childbearing potential (WOCBP) able and willing to use highly effective methods of birth control3 that result in a low failure rate of less than 1% per year when used consistently for the duration of the study + 7 days after last dose to comply with CTCG Contraception guidance Version 1.2 (CTCG 07.03.2024).
6. Able and willing to perform all study procedures, including at-home saliva collection, for the duration of the study
7. Negative hepatitis B serology defined as hepatitis B surface antigen (HBsAg) negative and Hepatitis B core antibody (anti-HBc) negative.

Exclusion criteria 18

1. Known hypersensitivity or severe adverse reactions to the study medication’s active agent or other component.
2. History of pancreatitis.
3. Prior or current disorders influence the participant’s ability to give informed consent or to comply with treatment and follow-up of the protocol.
4. Current users of medications that could interact with the study medication (listed in paragraph 5.6).
5. Participants previously treated with hematopoietic stem cell transplantation (HSCT).
6. Participants who previously have been treated with any chemotherapeutic medication.
7. WBC < 1.5 x 10^9/L if not caused by a reversible effect of documented ongoing medication. If WBC < 1.5 x 10^9/L is caused by a reversible effect of documented ongoing medication the WBC count must be > 1.5 x 10^9/L before start of study treatment.
8. History of liver disease
9. History of kidney disease
10. Platelet (thrombocyte) count < 100 x 10^9/L.
11. ALAT over the upper normal reference limit.
12. Serum creatinine over the upper normal reference limit.
13. Serum bilirubin over the upper normal reference limit.
14. Any other disease that can influence participant safety and compliance or the evaluation of the outcome.
15. Currently enrolled in another investigational drug trial, or within 30 days of completing one. Participants are excluded until systemic exposure has cleared, defined as 5.5 half-lives or 30 days, whichever is longer
16. Women who are pregnant, as verified by a serum pregnancy test at screening and during follow-up, or lactating.
17. Any known ongoing infection with HIV, chronic active hepatitis, hepatitis C, or hepatitis B surface antigen positivity.
18. Participants with any evidence of current or prior hepatitis B infection (including anti-HBc positivity) will be excluded to eliminate the risk of viral reactivation or flare following discontinuation of study treatment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Number of participants experiencing treatment-emergent adverse events (AEs).

Secondary endpoints 5

1. Within-participants changes in EBV shedding frequency in saliva, defined as number of samples with detectable levels of EBV during sequential dose escalation.
2. Within-participant changes in EBV viral load in saliva during sequential dose escalation.
3. Within-participant changes in EBV specific CD4 T cells by ELISPOT assay during sequential dose escalation.
4. Within-participant changes in IgG antibodies to EBNA1 and VCA during sequential dose escalation.
5. Secondary safety endpoints related to the IMP

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Helse Bergen HF

Sponsor organisation

Helse Bergen HF

Address

Haukelandsveien 22

City

Bergen

Postcode

5021

Country

Norway

Scientific contact point

Organisation

Helse Bergen HF

Contact name

Andrea Kyvik Habbestad

Public contact point

Organisation

Helse Bergen HF

Contact name

Andrea Kyvik Habbestad

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications