Hôpital Saint Louis AP-HP
Paris, France
Location status: Recruiting
NCT Number: NCT06876467
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 The first generation of plasma-based vaccines, introduced in the 1980s, has now been superseded by protein vaccines, which are the only ones authorized in France.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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Paris, France
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
detection of HBsAg-specific T lymphocytes by spectral cytometry
Time frame: At inclusion
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
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
Before and after vaccination 4 weeks prior to vaccination and 5 to 10 weeks after vaccination
Time frame: At inclusion
5 to 10 weeks after vaccination
Time frame: At inclusion
5 to 10 weeks after vaccination
Contact information is provided by the study sponsor or research team.
Jérôme Lambert, MD PhD
CONTACT
142499742 ext. +33
Jérôme Le Goff, MD PhD
CONTACT
1 42 49 94 93 ext. +33
Assistance Publique - Hôpitaux de Paris
Other
Etude de la réponse Cellulaire Induite Post-vaccination Contre le Virus de l'hépatite B
Acronym: HBVax
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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