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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

NCT05028322 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-08-31

No results posted yet for this study

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

Interventions

DRUG

IMIQUIMOD cream

Cream to apply before intra-dermal vaccine injection

BIOLOGICAL

HEPATITIS B SURFACE ANTIGEN

HBV Vaccine

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2024-12-01
Completion
2024-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05028322 on ClinicalTrials.gov