Effectiveness and Safety of Intra-Dermal Hepatitis B Vaccination After Topical Application of IMIQUIMOD, in Cirrhotics Patients, Who Did Not Respond to the Conventional Vaccine Regimen: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Proportion of patients in each groups, with HBs antibody levels greater than 10mUI/mL at 1 month of the last injection of vaccine
研究概览
简要总结
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.
详细描述
This study will be in a population of Cirrhotic patients who have already received a HBV vaccination with a conventional regimen and who have not responded (characterized by a level of antibody Hbs < 10UI/ml at the end of the vaccine regimen).
In current recommendations, up to 3 additional injections of HBV vaccine should be injected to obtain an antibody level> 10 mIU / ml.
In this study, the investigator will 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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/
- •Personne referred to sections L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code. Pregnant, parturient or breastfeeding mother 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.
- •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.
研究组 & 干预措施
Intra-muscular vaccination (Group 1)
This group corresponds to the use of the vaccine as used in the current recommendations.
干预措施: HEPATITIS B SURFACE ANTIGEN (Biological)
Intra-dermal vaccination group without application of IMIQUIMOD cream (Group 2)
Administration mode change for Intra-dermal vaccination. ( Instead of Intra-musculaire ) , to have a comparative with the experimental group.
干预措施: HEPATITIS B SURFACE ANTIGEN (Biological)
Intra-dermal vaccination group with application of IMIQUIMOD cream (Group 3)
Intra-dermal vaccin administration, with an immunity booster few minutes before by IMIQUIMOD application cream.
Experimental group.
干预措施: IMIQUIMOD cream (Drug)
Intra-dermal vaccination group with application of IMIQUIMOD cream (Group 3)
Intra-dermal vaccin administration, with an immunity booster few minutes before by IMIQUIMOD application cream.
Experimental group.
干预措施: HEPATITIS B SURFACE ANTIGEN (Biological)
结局指标
主要结局
Proportion of patients in each groups, with HBs antibody levels greater than 10mUI/mL at 1 month of the last injection of vaccine
时间窗: 1 month of the last injection of vaccine, it means 1 month after the end of the total procedure.
Describe the proportion of patients with HBs antibody levels greater than 10mUI/mL at 1 month of the last injection of vaccine ; with a M0M1-M6 vaccine regimen using 3 vaccines strategies: * After simple intramuscular vaccine (IM) ( Control group , group 1) * After simple intradermal vaccine without IMIQUIMOD ( Group 2 ) * after IMIQUIMOD's application followed by intradermal vaccine administration ( Group 3 )
次要结局
- Describe the proportion of patients with an anti-HB antibody level greater than 10mUI/mL at 1 month of the first injection (M1) with a vaccine regimen according to the vaccine strategy(1 month of the first vaccine injection (Month 1))
- Describe the proportion of patients with an anti-HB antibody level greater than 10mUI/mL at 6 months of the first injection (M6) with a vaccine regimen according to the vaccine strategy(6 months of the first vaccine injection (Month 6))
- Describe the evolution of the level of anti-HBs antibodies between 2 successive visits according to the vaccine strategy(-Day 0 / Month 0 ; - Day 30 / Month 1 ; - Day 180 / Month 6 ; - Day 210 / Month 7)
- Describe the rate of adverse events (by severity level) following the injection of a dose of intradermal vaccine(In each visit ( Month 1 , Month 6 , Month 7 ))
- Describe the rate of adverse events (by severity level) following the injection of an intradermal vaccine dose after prior application of Imiquimod(In each visit ( Month 1 , Month 6 , Month 7 ))