NCT06876467 Study of the Cellular Response Induced After Vaccination Against the Hepatitis B Virus
| NCT ID | NCT06876467 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Hepatitis B Vaccination |
| Study Type | OBSERVATIONAL |
| Enrollment | 115 participants |
| Start Date | 2025-08-11 |
| Primary Completion | 2028-12-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 115 participants in total. It began in 2025-08-11 with a primary completion date of 2028-12-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
296 million people worldwide are infected with the hepatitis B virus (HBV), despite the existence of an effective prophylactic vaccine. Current treatments (nucleoside analogues and pegylated interferon-α) do not prevent chronic hepatitis B (CHB) patients from developing liver fibrosis or hepatocellular carcinoma. Vaccination is the best way to prevent HBV infection. The first generation of plasma-based vaccines, introduced in the 1980s, has now been superseded by protein vaccines, which are the only ones authorized in France. They are safe and effective. After an initial series of three out of four doses, protective levels of antibodies to the HBV surface antigen (anti-HBsAg; ≥10 IU/mL) are achieved in over 95% of infants, children and young adults. HBV antigen (Ag)-specific CD4+ and CD8+ T lymphocytes play a major role in the control of HBV infection, contributing to viral clearance and the pathophysiology of acute hepatitis B. However, during HBC, these HBV-specific T cells develop a dysfunctional phenotype and become 'exhausted'. T lymphocytes directed against surface protein antigens (HBsAg) are the most affected by depletion mechanisms - these disappear completely in chronically infected patients, suggesting an important role for these T lymphocytes in infection control. Interestingly, recent studies of rare patients undergoing functional recovery from chronic infection following antiviral treatment have shown a re-emergence of T lymphocytes directed against HBsAg, confirming the importance of these cells in controlling viral replication. Although the protection induced by hepatitis B vaccination has mainly been attributed to the humoral response, a few studies have documented the presence of HBsAg-specific T lymphocytes. These could contribute to the maintenance of a long-term post-vaccination humoral response. The aim of this study is therefore to determine the frequency of healthy individuals receiving HBV vaccination who have a detectable HBsAg-specific T-cell response post-vaccination. We will also study the potential correlation between the frequency of HBsAg-specific T lymphocytes and the level of serum anti-HBsAg antibodies, and we will finely characterize the functional phenotype of these cells using cutting-edge methods and technologies (spectral cytometry, sequencing of mRNA and TCRs). These data will contribute to a better understanding of the biological mechanisms associated with HBV vaccine-induced protection.
Eligibility Criteria
Inclusion Criteria: * Adults ≥18 years * Pre-vaccination HBV serology carried out within 4 weeks prior to vaccination * Collection of no objection Exclusion Criteria: * Opposition of the person or inability to give opposition * Pregnant or breast-feeding women * Chronic illnesses affecting the individual's immune system (asplenia; hyposplenia; haematological cancer; auto-immune disease requiring immunosuppressive treatment, HIV infection). * Non-affiliation with a social security scheme, Universal Medical Coverage or any equivalent scheme
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06876467 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatitis B Vaccination. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06876467 currently recruiting?
Yes, NCT06876467 is actively recruiting participants. Contact the research team at jerome.le-goff@aphp.fr for enrollment information.
Where is the NCT06876467 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06876467 clinical trial?
NCT06876467 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 115 participants.