Specific Vaccine Therapy in Chronic Hepatitis B Using a Naked DNA: Phase I Study Using a GMO (RBM99026)

NCT00988767 Phase 1 COMPLETED

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.

Details

Lead sponsor	Institut National de la Santé Et de la Recherche Médicale, France
Phase	Phase 1
Status	COMPLETED
Enrolment	10
Start date	2001-02
Completion	2004-10

Conditions

• Chronic Hepatitis B

Interventions

• DNA vaccine

Primary outcomes

• 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

Countries

France