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Cirrhosis, LiverPhase 2IDMODVHBNCT05028322

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

A Phase 2 study testing IMIQUIMOD cream and HEPATITIS B SURFACE ANTIGEN in people with Cirrhosis, Liver and Vaccination Failure, run by Central Hospital, Nancy, France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cirrhosis, Liver, Vaccination Failure, HBV
What is being tested?
IMIQUIMOD cream and HEPATITIS B SURFACE ANTIGEN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Nov 2021to 1 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

About this study

Official title: 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

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 :

Read more
  • 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.

Read the detailed description

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
Being tested
IMIQUIMOD cream, HEPATITIS B SURFACE ANTIGEN
Medical subject headings
Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMIQUIMOD creamDrug

    Cream to apply before intra-dermal vaccine injection

  • HEPATITIS B SURFACE ANTIGENBiological

    HBV Vaccine

Study groups in NCT05028322
Study groupRoleWhat they receive
Intra-muscular vaccination (Group 1)Active comparatorThis group corresponds to the use of the vaccine as used in the current recommendations.
Receives: Biological: HEPATITIS B SURFACE ANTIGEN
Intra-dermal vaccination group without application of IMIQUIMOD cream (Group 2)Active comparatorAdministration mode change for Intra-dermal vaccination. ( Instead of Intra-musculaire ) , to have a comparative with the experimental group.
Receives: Biological: HEPATITIS B SURFACE ANTIGEN
Intra-dermal vaccination group with application of IMIQUIMOD cream (Group 3)ExperimentalIntra-dermal vaccin administration, with an immunity booster few minutes before by IMIQUIMOD application cream. Experimental group.
Receives: Drug: IMIQUIMOD cream; Biological: HEPATITIS B SURFACE ANTIGEN

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 )

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

Secondary outcomes (5)

  1. 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

    Rate 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

    Measured: 1 month of the first vaccine injection (Month 1)

  2. 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

    Rate 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

    Measured: 6 months of the first vaccine injection (Month 6)

  3. Describe the evolution of the level of anti-HBs antibodies between 2 successive visits according to the vaccine strategy

    • Anti-HBs Antibodies Level in the first vaccine injection = Day 0 / Month 0
    • Antibodies Level in the second vaccine injection = 30 days (1 month) after the first injection.
    • Antibodies Level in the third vaccine injection = 180 days (6months) after the first vaccine injection (or 150 days/5months after the second vaccine injection)
    • Antibodies Level at the end of the study : 210 days (7 months) after the first injection ; (or 30 days/1month after the third injection ) ;

    Measured: -Day 0 / Month 0 ; - Day 30 / Month 1 ; - Day 180 / Month 6 ; - Day 210 / Month 7

  4. 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 ) we describe the rate of adverse events (by severity level) following the injection of a dose of intradermal vaccine

    Measured: In each visit ( Month 1 , Month 6 , Month 7 )

  5. 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 ) we describe the rate of adverse events (by severity level) after injection of an intradermal vaccine dose after prior application of Imiquimod

    Measured: In each visit ( Month 1 , Month 6 , Month 7 )

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2021
  2. Study start1 Nov 2021 (estimated)
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05028322
Sponsor's protocol ID
2021-000644-22
Acronym
IDMODVHB
Status last verified
Jun 2021
First submitted
6 Jul 2021
Last updated
31 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Haghnejad V, Lucas M, Jacquinot N, Jeulin H, Daude S, Bensenane-Oussalah M, Schvoerer E, Bernard Y, Luc A, Bronowicki JP. Intradermal hepatitis B vaccination with or without Imiquimod in cirrhosis after prior vaccine nonresponse: A Randomised Trial. JHEP Rep. 2026 Sep 21:102039. doi: 10.1016/j.jhepr.2026.102039. Online ahead of print.

    PubMed 42767612

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMIQUIMOD cream and HEPATITIS B SURFACE ANTIGEN in people with Cirrhosis, Liver and Vaccination Failure, run by Central Hospital, Nancy, France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients in each groups, with HBs antibody levels greater than 10mUI/mL at 1 month of the last injection of vaccine (time frame: 1 month of the last injection of vaccine, it means 1 month after the end of the total procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05028322, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.

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