A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Prophylactic Hepatitis B Vaccine
NCT06147895 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-03-25
Summary
The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-HBV-002.
Conditions
- Vaccine-Preventable Diseases
- Hepatitis B
Interventions
- BIOLOGICAL
-
CVI-HBV-002
Investigational Product
Sponsors & Collaborators
-
CHA Vaccine Institute Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Youngsang Kim · CHA University Bundang Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-09-17
- Primary Completion
- 2023-09-25
- Completion
- 2023-09-25
Countries
- South Korea
Study Locations
More Related Trials
-
Long-term Persistence of Immunity to Hepatitis B in Adults Vaccinated With GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine (HBV), Engerix-B
NCT02901951 ·Status: COMPLETED ·Phase: PHASE4
-
Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers
NCT02055365 ·Status: COMPLETED ·Phase: NA
-
Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine, Injected According to 0, 6-month Schedule
NCT00289757 ·Status: COMPLETED ·Phase: PHASE4
-
Immunogenicity and Persistence of GlaxoSmithKline (GSK) Biologicals' Havrix® in Healthy Adult Subjects Vaccinated at Infancy Under the Hepatitis A Universal Mass Vaccination (UMV) Program in Israel
NCT03183492 ·Status: WITHDRAWN ·Phase: PHASE4
-
Hepatitis B Vaccine Delivered Trans-dermally by MAP
NCT06800131 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection
NCT03866187 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns
NCT01349283 ·Status: COMPLETED ·Phase: PHASE3
-
Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
NCT00240500 ·Status: COMPLETED ·Phase: PHASE4
-
Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System
NCT01777295 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate Induction of HBV Virus Neutralizing Antibodies Using VVX001
NCT03625934 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study to Evaluate the Safety and Immunogenicity of an Investigational Vaccine for Chronic Hepatitis B Virus Infection, in Healthy Adults
NCT06989788 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Safety and Immunogenicity of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine
NCT00657657 ·Status: COMPLETED ·Phase: PHASE4
-
The Immunogenicity and Safety of 60mcg/30mcg Recombinant Hepatitis B Vaccines in People Who Failed to Respond to Routine Administration of Hepatitis B Vaccines
NCT01203319 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study to Evaluate Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of Engerix™-B Kinder Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa During Infancy
NCT02798952 ·Status: COMPLETED ·Phase: PHASE4
-
Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With Engerix™-B Vaccine.
NCT00774995 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)
NCT00440531 ·Status: COMPLETED ·Phase: PHASE3
-
Safety of GlaxoSmithKline (GSK) Biologicals Hepatitis A Vaccine in Korean Population
NCT00237991 ·Status: COMPLETED
-
Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule
NCT00291876 ·Status: COMPLETED ·Phase: PHASE4
-
This Study Aims to Determine the Long-term Persistence of Antibodies Against Hepatitis B and to Evaluate the Immunogenicity and Safety of Hepatitis B Vaccine in Adolescents Vaccinated in Infancy With Infanrix™ Hexa
NCT02052661 ·Status: COMPLETED ·Phase: PHASE4
-
Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine
NCT00511095 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine
NCT02152709 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders
NCT02540538 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)
NCT00508833 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Clinical Trial of Recombinant Hepatitis B Vaccine (Hansenula Polymorpha, 10μg)
NCT04075201 ·Status: COMPLETED ·Phase: PHASE1
-
Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)
NCT00240539 ·Status: COMPLETED ·Phase: PHASE4