UnknownPhase 2

Evaluation of Intradermal Hepatitis B Vaccine After IMIQUIMOD's Application, in Cirrhotics Who Did Not Respond to the Usual Vaccine Regimen

60 participantsStarted 2021-11-01

Plain-language summary

In a population of cirrhotics patients who did not responde to an anti-HBV vaccination according to the recommended vaccination, the goal is to : Describe the proportion of patients with HBs antibody levels greater than 10mUI/mL at 1 month of the last injection of vaccine ; with a M0-M1-M6 vaccine regimen using 3 vaccines strategies : * After simple intramuscular vaccine (IM) ( Control group ) * After simple intradermal vaccine * after IMIQUIMOD's application followed by intradermal vaccine administration The main hypothesis of this study is : IMIQUIMOD acts as an immunity booster, so the combination of IMIQUIMOD with an intra-dermal injection of the anti-HBV vaccine allows better acquisition of post-vaccination immunization.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults (\> 18 years old) * Cirrhotic patient, all etiologies except related to chronic HBV infection. * Cirrhotic patient who did not respond to a 1st conventional hepatitis B vaccination regimen administered intramuscularly (ac Anti HBs \< 10 mUI/ml) * Person affiliated to a social security plan * Person who received complete information about the organization of the research and who signed informed consent Exclusion Criteria: * Patients with contraindication to the use of an intramuscular vaccine : Patients on Anticoagulants; Hemophiliac Patients, Patients with Severe Hemostasis Disorder (objectified by TP \< 30%; and/or a Thombopenia with platelets \< 30G/L) * Patients with end-stage chronic kidney failure defined by DFG \<15ml/min/1.73m2 \_ Hemodialysised Patients * Patients with a skin condition that does not allow vaccination (intradermal or intra-muscle): Skin sores on both arms: ulcers/abrasions/bubbles ; without healthy skin intervals. * Femme of childbearing age who does not have an effective method of contraception for the duration of the study. Effective contraceptive methods are defined as combined hormonal contraception (containing estrogen and progestin) combined with ovulation inhibition (oral, intravaginal, transdermal); or progestin-only hormonal contraception combined with ovulation inhibition (oral, injectable, implantable); or intrauterine device (IUD); or intrauterine hormone delivery system (IUS); or bilateral tubal occ…

What they're measuring

Proportion of patients in each groups, with HBs antibody levels greater than 10mUI/mL at 1 month of the last injection of vaccine

Timeframe: 1 month of the last injection of vaccine, it means 1 month after the end of the total procedure.

Trial details

NCT IDNCT05028322

SponsorCentral Hospital, Nancy, France

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-01