CVI-HBV-002 / CHA Vaccine Institute - LARVOL DELTA

A Study to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine (clinicaltrials.gov) - P2 | N=134 | Completed | Sponsor: CHA Vaccine Institute Co., Ltd. | Recruiting ➔ Completed

Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation

CVI-HBV-002: A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Prophylactic Hepatitis B Vaccine (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: CHA Vaccine Institute Co., Ltd.

New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine (clinicaltrials.gov) - P2 | N=153 | Recruiting | Sponsor: CHA Vaccine Institute Co., Ltd. | Trial primary completion date: Jul 2022 ➔ Dec 2023

Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Vaccine (clinicaltrials.gov) - P1/2 | N=53 | Completed | Sponsor: CHA Vaccine Institute Co., Ltd. | Unknown status ➔ Completed | N=36 ➔ 53

Enrollment change • Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine (clinicaltrials.gov) - P2 | N=153 | Recruiting | Sponsor: CHA Vaccine Institute Co., Ltd. | Unknown status ➔ Recruiting | Phase classification: P2b ➔ P2 | Trial completion date: Dec 2021 ➔ Dec 2023

Enrollment open • Phase classification • Trial completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

CHA Vaccine Research Institute “Expected to transfer hepatitis B vaccine technology in the first half of 2023“ [Google translation] (The Korea Economic Daily) - "Hepatitis B treatment vaccine candidate (CVI-HBV-002) is the most noteworthy pipeline in the CHA Vaccine Research Center and has undergone the most clinical trials...The goal is to complete the 2b phase in the first half of 2023 and transfer the technology (license out). Originally, there was talk of the second half of 2023, but according to a recent confirmation, it is said that the first half is planned as much as possible."

Trial completion date • Hepatitis B • Infectious Disease

CHA Vaccine sets ambitious targets ahead of IPO (Korea JoongAng Daily) - "CHA Vaccine Institute hopes to be the world’s first bio company to release therapeutic vaccine for chronic hepatitis B...It is just one of the ambitious plans the Korean vaccine maker offered up during an online briefing held Tuesday ahead of its initial public offering (IPO), scheduled for later this month...If the country succeeds in commercializing its candidate, CVI-HBV-002, it will be the such vaccine in world. The therapeutic vaccine candidate is currently undergoing Phase 2 clinical trials locally, including at Seoul National University Hospital."

Review • Hepatitis B • Infectious Disease

Cha Vaccine Institute to begin clinical study of hepatitis B third-generation vaccine (The Korea Herald) - "South Korean biotechnology company Cha Biotech has received approval from the Ministry of Food and Drug Safety for its plan to conduct a phase 1 clinical trial of a hepatitis B third-generation vaccine...Following the green light, Cha Vaccine Institute, the firm’s vaccine development subsidiary, will begin administrating the vaccine candidate to adults between the ages of 19-65, aiming to complete the study by October 2023."

Non-US regulatory • Trial completion date • Hepatitis B • Infectious Disease

Ministry of Food and Drug Safety, Tea Vaccine Research Institute approved phase 1 clinical trial for hepatitis B prevention vaccine [Google translator] (Health Korea News) - "The Tea Vaccine Research Institute is conducting a phase 1 clinical trial for the hepatitis B vaccine 'CVI-HBV-002'...the Ministry of Food and Drug Safety approved the Phase 1 clinical trial for 'CVI-HBV-002' (recombined hepatitis B surface antigen protein) from the Tea Vaccine Research Institute...clinical trial is an exploratory evaluation of the safety, reactivity, and immunogenicity of 'CVI-HBV-002', a hepatitis B vaccine, in 30 adults, and the clinical trial institution is CHA Bundang Hospital."

New P1 trial • Hepatitis B • Infectious Disease

’Cha Vaccine Research Institute’, affiliated with Cha Biotech, passed the technical evaluation on KOSDAQ [Google translation] (Chosun Biz) - "The Cha Vaccine Research Institute is currently conducting phase 2b clinical trials of 'CVI-HBV-002', a chronic hepatitis B vaccine, which is its main pipeline. In addition, it is developing next-generation vaccines such as hepatitis B vaccine..."

Clinical • Hepatitis B • Infectious Disease

A Study to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine (clinicaltrials.gov) - P2b; N=153; Recruiting; Sponsor: CHA Vaccine Institute Co., Ltd.

Clinical • New P2b trial