NCT02027116: VGX-6150-01

Multi-center, Open-label, Dose Escalation, Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Second-line Therapy of Chronic Hepatitis C Infection

Completed Phase 1 Last updated 4 August 2017

What this trial tests

Phase 1 trial testing VGX-6150 in Hepatitis C, Chronic in 18 participants. Completed in 1 July 2017.

Timeline

1 January 2014

Primary endpoint
1 July 2015

1 July 2017

Quick facts

Lead sponsor	GeneOne Life Science, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	1 January 2014
Primary completion	1 July 2015
Estimated completion	1 July 2017
Sites	2 locations across South Korea

Drugs / interventions tested

• VGX-6150 — full drug profile →

Conditions studied

• Hepatitis C, Chronic — all drugs for Hepatitis C, Chronic →

Sponsor

GeneOne Life Science, Inc. — full company profile →

Who can join

Adults 19 to 65, any sex, with Hepatitis C, Chronic. 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.

• Safety and Tolerability
  Time frame: Screening ~ week 36
  To evaluate the safety and tolerability of VGX-6150 as second-line therapy in chronic hepatitis C patients.

Sponsor's own description

To evaluate the safety, tolerability and immunogenicity of VGX-6150 as second-line therapy in chronic hepatitis C patients

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cytomegalovirus Vaccines: Current Status and Future Prospects.
   Anderholm KM, Bierle CJ, Schleiss MR. · · 2016 · cited 85× · PMID 27882457 · DOI 10.1007/s40265-016-0653-5
2. Regulatory T cells and their associated factors in hepatocellular carcinoma development and therapy.
   Zhang CY, Liu S, Yang M. · · 2022 · cited 32× · PMID 36158267 · DOI 10.3748/wjg.v28.i27.3346
3. Recent Advances in Protective Vaccines against Hepatitis Viruses: A Narrative Review.
   Elbahrawy A, Atalla H, Alboraie M, Alwassief A, et al · · 2023 · cited 22× · PMID 36680254 · DOI 10.3390/v15010214
4. IFNL3-adjuvanted HCV DNA vaccine reduces regulatory T cell frequency and increases virus-specific T cell responses.
   Han JW, Sung PS, Hong SH, Lee H, et al · · 2020 · cited 22× · PMID 32088322 · DOI 10.1016/j.jhep.2020.02.009
5. Strong HCV NS3/4a, NS4b, NS5a, NS5b-specific cellular immune responses induced in Rhesus macaques by a novel HCV genotype 1a/1b consensus DNA vaccine.
   Latimer B, Toporovski R, Yan J, Pankhong P, et al · · 2014 · cited 19× · PMID 25424943 · DOI 10.4161/hv.29590
6. Preclinical evaluation of multi antigenic HCV DNA vaccine for the prevention of Hepatitis C virus infection.
   Lee H, Jeong M, Oh J, Cho Y, et al · · 2017 · cited 18× · PMID 28266565 · DOI 10.1038/srep43531
7. Innate Immune Response against Hepatitis C Virus: Targets for Vaccine Adjuvants.
   Sepulveda-Crespo D, Resino S, Martinez I. · · 2020 · cited 13× · PMID 32560440 · DOI 10.3390/vaccines8020313
8. In the era of rapid mRNA-based vaccines: Why is there no effective hepatitis C virus vaccine yet?
   Echeverría N, Comas V, Aldunate F, Perbolianachis P, et al · · 2021 · cited 12× · PMID 34786164 · DOI 10.4254/wjh.v13.i10.1234