Last reviewed · How we verify
NCT05028322: IDMODVHB
Evaluation of Intradermal Hepatitis B Vaccine After IMIQUIMOD's Application, in Cirrhotics Who Did Not Respond to the Usual Vaccine Regimen
Phase 2 trial testing IMIQUIMOD cream in Cirrhosis, Liver in 60 participants. Status unknown.
1 December 2024
Quick facts
| Lead sponsor | Central Hospital, Nancy, France |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 1 November 2021 |
| Primary completion | 1 December 2024 |
| Estimated completion | 1 December 2024 |
Drugs / interventions tested
- IMIQUIMOD cream
- HEPATITIS B SURFACE ANTIGEN — full drug profile →
Conditions studied
- Cirrhosis, Liver — all drugs for Cirrhosis, Liver →
- Vaccination Failure — all drugs for Vaccination Failure →
- HBV — all drugs for HBV →
- Vaccine Reaction — all drugs for Vaccine Reaction →
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):
-
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 -
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:
- PubMed search for NCT05028322
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cirrhosis, Liver
Currently open trials in the same condition.
- NCT07286643 — Echocardiography-guided Cirrhosis and Liver Failure-Intensive Care Protocol Sepsis · NA · recruiting
- NCT06871111 — The Microbiota Augmentation to Reestablish Commensal Organisms (MARCO) Trial · Phase 1 · recruiting
- NCT07122700 — Evaluation of Non-Invasive Tests for Metabolic Liver Disease · recruiting
- NCT07051369 — Frequency of Portal Hypertension Among Patient With Cirrhotic Liver With Ultrasound · active not recruiting
- NCT06908785 — Utility of ROTEM® for Risk Stratification of Post-Invasive Procedure Hemorrhage in Patients With Cirrhosis (CIR-ROTEM) · recruiting
Other Central Hospital, Nancy, France trials
Trials by the same sponsor.
- NCT06452290 — PET Biomarker Study for Antidepressant Response Prediction in Major Depressive Disorder · NA · not yet recruiting
- NCT07518498 — Hypnosis During Mechanical Ventilation Weaning · NA · not yet recruiting
- NCT07471334 — Prospective Study of Postictal Psychotic Symptoms Occuring After Video-EEG Monitoring in Focal Epilepsies · NA · not yet recruiting
- NCT07414667 — Primary Sjögren's Syndrome: Impact of Quantitative Anti-Ro52 Antibody Analysis on Patient Prognosis and Stratification ( · not yet recruiting
- NCT07415759 — Imaging of Electrical Properties by MRI: Investigation of Age-Related Changes · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05028322 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Central Hospital, Nancy, France
- Last refreshed: 31 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05028322.
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