Cellular response after hepatitis B vaccination
Etude de la réponse Cellulaire Induite Post-vaccination Contre le Virus de l'hépatite B
This project will test how adults' immune cells, especially T cells, change after receiving a hepatitis B vaccine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 115 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06876467 on ClinicalTrials.gov |
What this trial studies
This is an observational study enrolling adults who will receive hepatitis B vaccination and have pre‑vaccination serology within four weeks of the first dose. Investigators will collect blood to isolate PBMCs, run serology, perform spectral cytometry to profile immune cell populations, and conduct RNA sequencing to examine gene-expression changes in responding cells. The protocol focuses on characterizing antigen-specific CD4+ and CD8+ T‑cell responses and other cellular signatures that accompany protective antibody development. Results will compare cellular and molecular profiles across participants to identify patterns linked to strong or weak vaccine responses.
Who should consider this trial
Good fit: Adults aged 18 or older who are willing to have pre‑vaccination HBV serology within four weeks before vaccination, can give consent, are not pregnant or breastfeeding, and are enrolled in a social security or equivalent health coverage scheme are ideal candidates.
Not a fit: People with chronic immune‑suppressing conditions (e.g., asplenia, haematological cancer, autoimmune disease on immunosuppression, HIV), pregnant or breastfeeding women, or those unable to provide required consent or health coverage are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the work could identify immune markers of strong protection that help tailor vaccination strategies or guide next‑generation vaccine design.
How similar studies have performed: Licensed protein‑based hepatitis B vaccines reliably produce protective antibodies in most people and prior studies have documented T‑cell involvement, while deep profiling with spectral cytometry and RNA sequencing represents a more recent, specialized approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Hôpital Saint Louis AP-HP — Paris, France (Recruiting)
Study contacts
- Study coordinator: Jérôme Le Goff, MD PhD
- Email: jerome.le-goff@aphp.fr
- Phone: 1 42 49 94 93
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.