Efficacy and Tolerance of Naked DNA Vaccine in Patients With Chronic B Hepatitis (NCT00536627) | Clinical Trial Compass
CompletedPhase 1/2
Efficacy and Tolerance of Naked DNA Vaccine in Patients With Chronic B Hepatitis
France70 participantsStarted 2008-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
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
Timeframe: at week 72
Trial details
NCT IDNCT00536627
SponsorFrench National Agency for Research on AIDS and Viral Hepatitis