Effectiveness and Safety of Intra-Dermal Hepatitis B Vaccination after a local application of cream, called IMIQUIMOD, in cirrhotic patients who did not respond to the conventional (intra-muscular) vaccine regimen.
EU CTIS ID: 2024-514605-61-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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 occlusion; or a vasectomized partner; or sexual abstinence; Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Menopause is defined as the absence of menstruation for at least 12 months. According to CTFG recommendations related to contraception and pregnancy testing in clinical trials; version 1.1 of 21/09/2020. _Personne referred to sections L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code. Pregnant, parturient or breastfeeding mother. Verification of the absence of a current pregnancy will be carried out by a urinary Beta HCG assay. It should be noted that the vast majority of cirrhotic patients followed up in hepatology consultations are women over 60 years of age and menopausal. Minor (unassecipated) An adult subject to a legal protection measure (tutelage, curate, safeguarding of justice) Adult person undying to express consent _Persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under sections L. 3212-1 and L. 3213- 1. - Vaccination during the 4 weeks (28 days) prior to the first vaccination in the trial - Previous vaccination with another investigational vaccine - Subjects who have received immunoglobulins, blood or blood derivatives within the last 3 months. - Known or suspected congenital or acquired immunodeficiency; immunosuppressive therapy within the last 6 months, such as cancer chemotherapy or radiotherapy; long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the last 3 months). - Acute respiratory infection or severe acute febrile illness (temperature ≥ 38.0°C), or a systemic reaction that may be of significant risk with vaccination in the month prior to inclusion.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.