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NCT05028322: IDMODVHB

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

Status unknown Phase 2 Last updated 31 August 2021
What this trial tests

Phase 2 trial testing IMIQUIMOD cream in Cirrhosis, Liver in 60 participants. Status unknown.

Timeline
1 November 2021
Primary endpoint
1 December 2024
1 December 2024

Quick facts

Lead sponsorCentral Hospital, Nancy, France
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment60
Start date1 November 2021
Primary completion1 December 2024
Estimated completion1 December 2024

Drugs / interventions tested

Conditions studied

Sponsor

Central Hospital, Nancy, France

Who can join

18 and older, any sex, with Cirrhosis, Liver or Vaccination Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Recent Advances in the Development of Toll-like Receptor Agonist-Based Vaccine Adjuvants for Infectious Diseases.
    Yang JX, Tseng JC, Yu GY, Luo Y, et al · · 2022 · cited 81× · PMID 35214155 · DOI 10.3390/pharmaceutics14020423
  2. Pattern recognition receptors: function, regulation and therapeutic potential.
    Chen R, Zou J, Chen J, Zhong X, et al · · 2025 · cited 53× · PMID 40640149 · DOI 10.1038/s41392-025-02264-1

Verify or expand the search:

Other recruiting trials for Cirrhosis, Liver

Currently open trials in the same condition.

Other Central Hospital, Nancy, France trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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