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

NCT05028322 | Unknown Phase 2 DMC

• 1 other identifier: 2021-000644-22
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cirrhosis, Liver; Vaccination Failure; HBV; Vaccine Reaction

Outcome Measures

Primary Outcomes (1)

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

  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 )

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

Secondary Outcomes (5)

• 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 )

Study Arms (3)

Intra-muscular vaccination (Group 1)

ACTIVE COMPARATOR

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

Biological: HEPATITIS B SURFACE ANTIGEN

Intra-dermal vaccination group without application of IMIQUIMOD cream (Group 2)

ACTIVE COMPARATOR

Administration mode change for Intra-dermal vaccination. ( Instead of Intra-musculaire ) , to have a comparative with the experimental group.

Biological: HEPATITIS B SURFACE ANTIGEN

Intra-dermal vaccination group with application of IMIQUIMOD cream (Group 3)

EXPERIMENTAL

Intra-dermal vaccin administration, with an immunity booster few minutes before by IMIQUIMOD application cream. Experimental group.

Drug: IMIQUIMOD cream; Biological: HEPATITIS B SURFACE ANTIGEN

Interventions

IMIQUIMOD cream DRUG

Cream to apply before intra-dermal vaccine injection

Intra-dermal vaccination group with application of IMIQUIMOD cream (Group 3)

HEPATITIS B SURFACE ANTIGEN BIOLOGICAL

HBV Vaccine

Intra-dermal vaccination group with application of IMIQUIMOD cream (Group 3); Intra-dermal vaccination group without application of IMIQUIMOD cream (Group 2); Intra-muscular vaccination (Group 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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 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).

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Hepatitis B Surface Antigens

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hepatitis B Antigens; Hepatitis Antigens; Antigens, Viral; Viral Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: August 31, 2021
• Study Start: November 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 31, 2021

Record last verified: 2021-06