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

NCT ID: NCT05028322

Last Updated: 2021-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Cirrhosis, Liver Vaccination Failure HBV Vaccine Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intra-muscular vaccination (Group 1)

This group corresponds to the use of the vaccine as used in the current recommendations.

Group Type ACTIVE_COMPARATOR

HEPATITIS B SURFACE ANTIGEN

Intervention Type BIOLOGICAL

HBV Vaccine

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.

Group Type ACTIVE_COMPARATOR

HEPATITIS B SURFACE ANTIGEN

Intervention Type BIOLOGICAL

HBV Vaccine

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.

Group Type EXPERIMENTAL

IMIQUIMOD cream

Intervention Type DRUG

Cream to apply before intra-dermal vaccine injection

HEPATITIS B SURFACE ANTIGEN

Intervention Type BIOLOGICAL

HBV Vaccine

Interventions

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IMIQUIMOD cream

Cream to apply before intra-dermal vaccine injection

Intervention Type DRUG

HEPATITIS B SURFACE ANTIGEN

HBV Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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 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 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. 32131.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2021-000644-22

Identifier Type: -

Identifier Source: org_study_id