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NCT03463369
A First-In-Human Study to Evaluate Safety, Tolerability, Reactogenicity, and Immunogenicity of JNJ-64300535, a DNA Vaccine, Administered by Electroporation-Mediated Intramuscular Injection, in Participants With Chronic Hepatitis B Who Are on Stable Nucleos(t)Ide Therapy and Virologically Suppressed
Phase 1 trial testing JNJ-64300535 in Hepatitis B, Chronic in 30 participants. Completed in 23 March 2021.
23 March 2021
Quick facts
| Lead sponsor | Janssen Sciences Ireland UC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | triple |
| Primary purpose | other |
| Enrollment | 30 |
| Start date | 18 April 2018 |
| Primary completion | 23 March 2021 |
| Estimated completion | 23 March 2021 |
| Sites | 14 locations across Belgium, United Kingdom, Germany |
Drugs / interventions tested
- JNJ-64300535 — full drug profile →
- Placebo
- Nucleos(t)ide Analogs (NA) — full drug profile →
Conditions studied
- Hepatitis B, Chronic — all drugs for Hepatitis B, Chronic →
Sponsor
Janssen Sciences Ireland UC — full company profile →
Who can join
Adults 18 to 55, any sex, with Hepatitis B, Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the safety, tolerability, and reactogenicity of escalating doses of JNJ-64300535 delivered via electroporation-mediated intramuscular injection in nucleos(t)ide analogs (NA)-treated chronic hepatitis B (CHB) participants.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Development of Direct-acting Antiviral and Host-targeting Agents for Treatment of Hepatitis B Virus Infection.
Xia Y, Liang TJ. · · 2019 · cited 91× · PMID 30243618 · DOI 10.1053/j.gastro.2018.07.057 -
Hepatitis B Virus Cure: Targets and Future Therapies.
Lee HW, Lee JS, Ahn SH. · · 2020 · cited 75× · PMID 33379331 · DOI 10.3390/ijms22010213 -
Therapeutic vaccination for treatment of chronic hepatitis B.
Cargill T, Barnes E. · · 2021 · cited 63× · PMID 33969474 · DOI 10.1111/cei.13614 -
Toward a complete cure for chronic hepatitis B: Novel therapeutic targets for hepatitis B virus.
Kim SW, Yoon JS, Lee M, Cho Y. · · 2022 · cited 53× · PMID 34281294 · DOI 10.3350/cmh.2021.0093 -
New Approaches to the Treatment of Chronic Hepatitis B.
Alexopoulou A, Vasilieva L, Karayiannis P. · · 2020 · cited 50× · PMID 33019573 · DOI 10.3390/jcm9103187 -
Toward a new era of hepatitis B virus therapeutics: The pursuit of a functional cure.
Tsounis EP, Tourkochristou E, Mouzaki A, Triantos C. · · 2021 · cited 33× · PMID 34135551 · DOI 10.3748/wjg.v27.i21.2727 -
Meeting the Challenge of Eliminating Chronic Hepatitis B Infection.
Revill PA, Penicaud C, Brechot C, Zoulim F. · · 2019 · cited 25× · PMID 30939846 · DOI 10.3390/genes10040260 -
Novel Antivirals in Clinical Development for Chronic Hepatitis B Infection.
Mak LY, Seto WK, Yuen MF. · · 2021 · cited 20× · PMID 34207458 · DOI 10.3390/v13061169
Verify or expand the search:
- PubMed search for NCT03463369
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of JNJ-64300535
Trials testing the same drug.
- NCT05123599 — A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBe · Phase 1 · completed
- NCT04736147 — A Study of JNJ-64300535 in Healthy Participants · Phase 1 · completed
Other recruiting trials for Hepatitis B, Chronic
Currently open trials in the same condition.
- NCT07370207 — Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region · Phase 2 · recruiting
- NCT06550622 — Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion · recruiting
- NCT06550128 — Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB). · Phase 2 · active not recruiting
- NCT06525909 — A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B · recruiting
- NCT05937178 — Real-world Study Optimizing Nucleotide-analogues · recruiting
Other Janssen Sciences Ireland UC trials
Trials by the same sponsor.
- NCT04208399 — A Study to Evaluate the Effect of Hepatic Impairment on JNJ-56136379 · Phase 1 · completed
- NCT04208386 — A Study to Evaluate the Effect of Hepatic Impairment on JNJ-73763989 · Phase 1 · completed
- NCT04056611 — Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who A · Phase 2 · terminated
- NCT04129554 — A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virolo · Phase 2 · completed
- NCT03982186 — A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepati · Phase 2 · completed
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 NCT03463369 (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 Janssen Sciences Ireland UC
- Last refreshed: 14 April 2021
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/NCT03463369.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing