Safety Study of HBV DNA Vaccine to Treat Patients With Chronic Hepatitis B Infection

NCT00277576 | Completed Phase 1

• 1 other identifier: PM HBV-001
• Study Type: interventional
• Target: 48
• Locations: 4 countries
• Sites: 9

Brief Summary

The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to reduce hepatitis B disease.

Conditions

Chronic Hepatitis B

Keywords

DNA vaccine; immunotherapy; Hepatitis B Virus; Particle Mediated Epidermal Delivery

Outcome Measures

Primary Outcomes (1)

• Adverse Events at all visits, vaccine site evaluations, laboratory parameters pre and post vaccination

Secondary Outcomes (3)

• The secondary endpoints will assess the effect of the Investigational Product on:

• immunological response to vaccine at each visit

• clinical response to vaccine at each visit

Interventions

ppdpSC18 administered by PMED BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Otherwise healthy, treatment naïve subjects with chronic well compensated, eAg positive HBV infection

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• PowderMed: lead

Study Sites (9)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

19/F Prince of Wales Hospital

Shatin, Hong Kong

Location

Alice Ho Miu Ling Nethersole Hospital

Tai Po, N. T., Hong Kong

Location

National University Hospital

Singapore, 119074, Singapore

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Cathay General Hospital

Taipei, 106, Taiwan

Location

Chang Gung Memorial Hospital - Linko

Taoyan, 33, Taiwan

Location

Siriraj Hospital

Bangkok, Thailand

Location

Maharaj Nakorn Chiangmai Hospital

Chiang Mai, Thailand

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

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

Study Officials

• Henry LY Chan

  Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

• Nancy Leung

  Alice Ho Miu Ling Nethersole Hospital

  PRINCIPAL INVESTIGATOR

• Seng Gee Lim

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

• Wan Cheng Chow

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

• Sien-Sing Yang

  Cathay General Hospital

  PRINCIPAL INVESTIGATOR

• I Shyan-Sheen

  Chang Gung Memorial Hospital - Linko

  PRINCIPAL INVESTIGATOR

• Satawat Thongsawat

  Maharaj Nakorn Chiang Mai Hospital

  PRINCIPAL INVESTIGATOR

• Tawesak Tandwandee

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

• Man Fung Yuen

  Queen Mary Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 13, 2006
• First Posted: January 16, 2006
• Study Start: January 1, 2006
• Study Completion: December 1, 2007
• Last Updated: November 21, 2008

Record last verified: 2008-11

Locations

TW (2); HK (3); SG (2); TH (2)