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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 The first generation of plasma-based vaccines, introduced in the 1980s, has now been superseded by protein vaccines, which are the only ones authorized in France.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

This trial accepts healthy volunteers

Qualifiers

Adults ≥18 years

Pre-vaccination HBV serology carried out within 4 weeks prior to vaccination

Collection of no objection

Disqualifiers

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

Trial population

Healthy individuals receiving HBV vaccination

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Evaluation of cellular response

    Other intervention

    detection of HBsAg-specific T lymphocytes by spectral cytometry

Treatment groups

115 Participants
are divided into 1 treatment group
Group A: Healthy individuals receiving HBV vaccination1 intervention

Trial outcomes

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

Time frame
At inclusion

Secondary outcomes

1

Frequency of pehotypes of T lymphocytes post-HBV vaccination

Phenotypic and functional characterization of HBsAg-specific CD4+ and CD8+ T lymphocytes post-HBV vaccination Quantitative results obtained by spectral cytometry and RNA sequencing to characterise HBsAg-specific LTs 5 to 10 weeks after HBV vaccination

Time frame
At inclusion
2

Anti-HBsAg antibody levels

Before and after vaccination 4 weeks prior to vaccination and 5 to 10 weeks after vaccination

Time frame
At inclusion
3

Percentage of LT CD4 circulating cells

5 to 10 weeks after vaccination

Time frame
At inclusion
4

Percentage of LT CD8 circulating cells

5 to 10 weeks after vaccination

Time frame
At inclusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.