Study of the Cellular Response Induced After Vaccination Against the Hepatitis B Virus

NCT06876467 | Recruiting

• 1 other identifier: APH241703
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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 The first generation of plasma-based vaccines, introduced in the 1980s, has now been superseded by protein vaccines, which are the only ones authorized in France.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.

Conditions

Hepatitis B Vaccination; Immune Response; T Cells

Keywords

PBMCs isolation; Serology; Spectral cytometry; RNA sequencing

Outcome Measures

Primary Outcomes (1)

• Proportion of individuals with a cellular response

  Proportion of individuals with a cellular response directed against HBsAg following HBV vaccination At inclusion, 5 to 10 weeks after HBV vaccination

  At inclusion

Secondary Outcomes (4)

• Frequency of pehotypes of T lymphocytes post-HBV vaccination

  At inclusion

• Anti-HBsAg antibody levels

  At inclusion

• Percentage of LT CD4 circulating cells

  At inclusion

• Percentage of LT CD8 circulating cells

  At inclusion

Study Arms (1)

Healthy individuals receiving HBV vaccination

Other: Evaluation of cellular response

Interventions

Evaluation of cellular response OTHER

detection of HBsAg-specific T lymphocytes by spectral cytometry

Healthy individuals receiving HBV vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy individuals receiving HBV vaccination

You may qualify if:

• Adults ≥18 years
• Pre-vaccination HBV serology carried out within 4 weeks prior to vaccination
• Collection of no objection

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint Louis AP-HP

Paris, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

Central Study Contacts

Jérôme Le Goff, MD PhD

CONTACT

1 42 49 94 93; jerome.le-goff@aphp.fr

Jérôme Lambert, MD PhD

CONTACT

142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): December 11, 2028
• Study Completion (Estimated): December 11, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

FR (1)