Efficacy and Tolerance of Naked DNA Vaccine in Patients With Chronic B Hepatitis

NCT00536627 | Completed Phase 1 DMC

• 2 other identifiers: ANRS HB02 VAC-ADN2007-001682-15
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if DNA vaccination of chronic HBV patients under treatment with NRTI can restore T-cell responsiveness and delay virologic reactivation after treatment discontinuation.

Conditions

Chronic Hepatitis B

Keywords

DNA vaccine

Outcome Measures

Primary Outcomes (1)

• Primary endpoint is virologic failure defined by 1) reactivation after analogs' treatment interruption, 2) virologic breakthrough during treatment with analogs, 3) the impossibility for the patients to interrupt treatment at week 48

  at week 72

Secondary Outcomes (4)

• Delay of appearance of virologic failure

  at Week 72

• Biological and clinical tolerance of DNA vaccine

  all along the trial

• Immunological responses

  At weeks 18, 40, 46, 60, 72

• Clinical progression of hepatitis B

  all along the trial

Study Arms (2)

1

EXPERIMENTAL

Patients will receive 5 injections of DNA vaccine at weeks 0, 8, 16, 40, 44.

Biological: DNA vaccine pCMVS2.S

2

NO INTERVENTION

Interventions

DNA vaccine pCMVS2.S BIOLOGICAL

Patients will receive injections of 1 ml of vaccine (1 mg/ml) at weeks 0, 8, 16, 40 and 44

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic hepatitis B with or without AgHBe
• no cirrhosis and no hepatocellular carcinoma
• treatment with NRTI unchanged for at least 3 months
• undetectable HBV viral load for 12 months
• HBV viral load \< 12 IU/ml at screening
• sGPT \< 5N
• tetanus immunization or booster dose for less than 8 years
• accurate birth control or menopausal women or sterility
• sickness insurance
• signed informed consent

You may not qualify if:

• HLA-DR 15/16
• coinfections with HDV, HCV and/or HIV
• treatment with immunomodulators
• immunosuppressors
• long-term corticotherapy (over 4 weeks)
• active intravenous drug-users
• prolonged and excessive consumption of alcohol (men \> 40g/day ; women \> 30g/day ; for more than 5 years)
• medical history of autoimmune disease or presence of autoantibodies
• previous immunization by HBV vaccine of less than 5 years
• previous immunization by DNA vaccine against HBV
• personal or family medical history of demyelinising diseases
• uncontrolled hypophosphatemia
• renal failure, renal transplantation, haemodialysis
• pregnancy, breast-feeding

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

FONTAINE Hélène

Paris, France

Location

Related Publications (4)

• 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

• 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

• Fontaine H, Kahi S, Chazallon C, Bourgine M, Varaut A, Buffet C, Godon O, Meritet JF, Saidi Y, Michel ML, Scott-Algara D, Aboulker JP, Pol S; ANRS HB02 study group. Anti-HBV DNA vaccination does not prevent relapse after discontinuation of analogues in the treatment of chronic hepatitis B: a randomised trial--ANRS HB02 VAC-ADN. Gut. 2015 Jan;64(1):139-47. doi: 10.1136/gutjnl-2013-305707. Epub 2014 Feb 20.

  PMID: 24555998 DERIVED

• Godon O, Fontaine H, Kahi S, Meritet JF, Scott-Algara D, Pol S, Michel ML, Bourgine M; ANRS HB02 study group. Immunological and antiviral responses after therapeutic DNA immunization in chronic hepatitis B patients efficiently treated by analogues. Mol Ther. 2014 Mar;22(3):675-684. doi: 10.1038/mt.2013.274. Epub 2013 Dec 5.

  PMID: 24394187 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; 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

Study Officials

• Hélène FONTAINE, MD

  Pôle d'Hépatologie, Hôpital COCHIN, PARIS, FRANCE

  PRINCIPAL INVESTIGATOR

• Jean-Pierre ABOULKER, MD

  INSERM SC-10, VILLEJUIF, FRANCE

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 26, 2007
• First Posted: September 28, 2007
• Study Start: January 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: April 2, 2026

Record last verified: 2011-12

Locations

FR (1)