Safety and Immunogenicity of a Naked DNA-based Vaccine Therapy in Patients With Chronic Hepatitis B

NCT00988767 | Completed Phase 1 DMC

• 1 other identifier: INSERM RBM99.026
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to investigate whether HBV-DNA vaccination is safe and could restore immune responses in patients with chronic hepatitis B non responder to available therapies.

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B; DNA vaccine; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability (local and general) of the DNA vaccine injections

  every Months from month 0 to month 12 and then M15, M18, M21 and M22

Secondary Outcomes (1)

• Immunological responses

  before DNA injection (M0), after DNA injection and during follow-up (M1, M3, M5, M10, M11, M15)

Study Arms (1)

intramuscular injections

EXPERIMENTAL

Patients received 4 injections of DNA vaccine at M0, M2, M4 and M10

Biological: DNA vaccine

Interventions

DNA vaccine BIOLOGICAL

patients received 1ml of DNA vaccine (1mg/ml) at Months 0,2,4,10

Also known as: pCMV-S2.S DNA

intramuscular injections

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• chronic HBV carriers
• biopsy proven chronic hepatitis
• active HBV replication for \> 6 months
• non responding to Interferon-alpha or lamivudine treatment

You may not qualify if:

• co-infection with HIV, HCV, delta hepatitis virus
• alcohol consumption\> 40g/day
• decompensated liver disease
• HLA DR2

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Service d'Hepatologie, Hopital Necker Enfants Malades

Paris, 75015, France

Location

Related Publications (3)

• Mancini-Bourgine M, Fontaine H, Scott-Algara D, Pol S, Brechot C, Michel ML. Induction or expansion of T-cell responses by a hepatitis B DNA vaccine administered to chronic HBV carriers. Hepatology. 2004 Oct;40(4):874-82. doi: 10.1002/hep.20408.

  PMID: 15382173 BACKGROUND

• Mancini-Bourgine M, Fontaine H, Brechot C, Pol S, Michel ML. Immunogenicity of a hepatitis B DNA vaccine administered to chronic HBV carriers. Vaccine. 2006 May 22;24(21):4482-9. doi: 10.1016/j.vaccine.2005.08.013. Epub 2005 Aug 18.

  PMID: 16310901 BACKGROUND

• Scott-Algara D, Mancini-Bourgine M, Fontaine H, Pol S, Michel ML. Changes to the natural killer cell repertoire after therapeutic hepatitis B DNA vaccination. PLoS One. 2010 Jan 18;5(1):e8761. doi: 10.1371/journal.pone.0008761.

  PMID: 20090916 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Interventions

Vaccines, DNA

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; Antigens; Biological Factors

Study Officials

• Helene FONTAINE, MD

  Assistance Publique des Hopitaux de paris, AP-HP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: February 1, 2001
• Primary Completion: November 1, 2003
• Study Completion: October 1, 2004
• Last Updated: September 26, 2025

Record last verified: 2009-10

Locations

FR (1)