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Efficacy and Safety of Dual-plasmid Hepatitis B Virus DNA Vaccine in Chronic Hepatitis B Patients

NCT01487876 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2011-12-08

No results posted yet for this study

Summary

In order to study the immunotherapeutic effects of electroporation (EP)-mediated dual-plasmids Hepatitis B Virus DNA vaccine, the investigators plan to conduct a double-blind, randomized, placebo-controlled trial, approved by Chinese State Food and Drug Administration with written informed consent from each chronic hepatitis B (CHB) patients with baseline ALT more than 2 times the ULN, for whom antiviral treatment is indicated and who were under the simultaneous lamivudine (LAM) chemotherapy.

Conditions

Interventions

BIOLOGICAL

HBV DNA vaccine

HBV DNA vaccine means that each volunteer received 4 injections of 4 mg DNA vaccine scheduled by a prime and 3 boosts at intervals of 4, 8, 12 weeks.

OTHER

Placebo

Placebo means the arm in which each volunteer received 4 injections of 4 mg placebo scheduled by a prime and 3 boosts at intervals of 4, 8, 12 weeks.

Sponsors & Collaborators

  • Fuqiang Yang

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-08-31
Completion
2012-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01487876 on ClinicalTrials.gov