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NCT00277576
Phase I, Multi-Centre, Randomised, Placebo-Controlled, Dose Escalation Study to Assess Local & Systemic Tolerability of Therapeutic DNA Plasmid pdpSC18 Vaccine Administered by Particle Mediated Epidermal Delivery Using PowderJect ND10 Delivery System in Subjects With Chronic Hepatitis B Infection
Phase 1 trial testing ppdpSC18 administered by PMED in Chronic Hepatitis B in 48 participants. Completed in 1 December 2007.
Quick facts
| Lead sponsor | PowderMed |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 1 January 2006 |
| Estimated completion | 1 December 2007 |
| Sites | 9 locations across Hong Kong, Singapore, Taiwan, Thailand |
Drugs / interventions tested
- ppdpSC18 administered by PMED — full drug profile →
Conditions studied
- Chronic Hepatitis B — all drugs for Chronic Hepatitis B →
Sponsor
PowderMed — full company profile →
Who can join
Adults 18 to 50, any sex, with Chronic Hepatitis B. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- Adverse Events at all visits, vaccine site evaluations, laboratory parameters pre and post vaccination
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
DNA vaccines for targeting bacterial infections.
Ingolotti M, Kawalekar O, Shedlock DJ, Muthumani K, et al · · 2010 · cited 77× · PMID 20624048 · DOI 10.1586/erv.10.57 -
Research and Development of Hepatitis B Drugs: An Analysis Based on Technology Flows Measured by Patent Citations.
Huang C, Lin HH, Wan JB, He C, et al · · 2016 · cited 2× · PMID 27727319 · DOI 10.1371/journal.pone.0164328
Verify or expand the search:
- PubMed search for NCT00277576
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Hepatitis B
Currently open trials in the same condition.
- NCT07275918 — SA1211 Injection Phase 1 Study · Phase 1 · recruiting
- NCT04843852 — TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B · Phase 1 · recruiting
- NCT07135349 — A Phase II Clinical Study of BW-20507 in Combination With PEG-IFNα for the Treatment of Hepatitis B · Phase 2 · active not recruiting
- NCT07307586 — A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatiti · Phase 3 · recruiting
- NCT07246889 — Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE) · Phase 3 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00277576 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PowderMed
- Last refreshed: 20 November 2008
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00277576.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing