Clinical trials: Hepatitis E Infection
Hepatitis E
A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)
This phase IV clinical study was designed to evaluate the safety and immunogenicity of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 65 years of…
- Trial name
- NCT02417597
- Testing
- Recombinant Hepatitis E Vaccine (Escherichia Coli)
- Where
- China
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Xiamen Innovax Biotech Co., Ltd
Hepatitis E
Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine（Hecolin®）
The purpose of this study is to determine the safety and immunogenicity of the recombinant hepatitis E vaccine in people older than 65 years, and evaluate the efficacy of hepatitis E vaccine in this population.
- Trial name
- NCT02189603
- Testing
- Recombinant (E. Coli) Hepatitis E Vaccine
- Where
- China
- Volunteers
- 601 people, healthy volunteers welcome
- Sponsor
- Jun Zhang
Hepatitis E Infection
Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women
This is a phase II randomized, observer-blinded, placebo-controlled study with 3 arms enrolling a total of 2,358 participants. The arms are composed of Arm 1, pregnant participants receiving Hecolin® (N=1,104) with immunogenicity…
- Trial name
- NCT05808166
- Testing
- Hecolin® (Recombinant Hepatitis E Vaccine (Escherichia coli))., Isotonic Sodium Chloride injection
- Where
- Pakistan
- Volunteers
- 2,358 people, healthy volunteers welcome
- Sponsor
- International Vaccine Institute
Hepatitis, Cytokines
Role of Cytokines in Hepatitis E Virus Infection During Pregnancy
Hepatitis E virus is a public health problem in several countries of the world where safe drinking water is a problem. HEV is an exclusive cause of epidemic hepatitis in general population.
- Conditions
- Hepatitis, Cytokines, Pregnancy
- Trial name
- NCT01062321
- Where
- India
- Volunteers
- 491 people, healthy volunteers welcome
- Sponsor
- Maulana Azad Medical College
Hepatitis E
A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Lot Consistency Trial)
This study is to evaluate lot-lot consistency of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin®.
- Trial name
- NCT03365921
- Testing
- Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
- Where
- China
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Xiamen Innovax Biotech Co., Ltd
Hepatitis E Virus Infection
Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children
The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin® in healthy children, compared to healthy adults as measured by seroresponse rates (SR) of anti-HEV IgG titers, 4 weeks after 3 doses…
- Trial name
- NCT06306196
- Testing
- Hecolin® Recombinant Hepatitis E Vaccine, Isotonic Sodium Chloride injection
- Where
- 3 sites in South Africa
- Volunteers
- 1,040 people, healthy volunteers welcome
- Sponsor
- International Vaccine Institute
Hepatitis C, Oxidative Stress
Blood Antioxidant Status in Chronic Hepatitis C Patients Before and After Antioxidant Supplementation: a Randomized Clinical Trial
The objective of the present study is to evaluate the antioxidant status in the blood of HCV patients treated with pegylated interferon (2a 1.5 ug/kg; 2b 180 ug) combined with ribavirin (1000 to 1250 mg) before and after…
- Trial name
- HepCAntSup (NCT00983164)
- Testing
- Antioxidant Supplementation
- Where
- 3 sites in Brazil
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Universidade do Sul de Santa Catarina
Hepatitis E
A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Chronic Hepatitis B Patients )
This phase IV clinical study was designed to evaluate the immunogenicity and safety of Hecolin® in the chronic Hepatitis B patients on the clinical stability.
- Trial name
- NCT02964910
- Testing
- Recombinant Hepatitis E Vaccine (Escherichia Coli)
- Where
- China
- Volunteers
- 475 people, healthy volunteers welcome
- Sponsor
- Xiamen Innovax Biotech Co., Ltd
Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18
Immunogenicity and Safety of Co-immunization With Cecolin and Hecolin
The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with recombinant human papillomavirus bivalent (Types 16,18) vaccine (Escherichia coli) and Hepatitis E vaccine (Escherichia coli)
- Conditions
- Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Hepatitis E Virus Infection
- Trial name
- NCT05415345
- Testing
- Cecolin, Hecolin
- Where
- China
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Xiamen Innovax Biotech Co., Ltd
Hepatitis E
A Clinical Trial to Evaluate a Recombinant Hepatitis E Vaccine in Healthy Adults
Hepatitis E is characteristic by sporadic and local epidemic around the world, and mainly infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to 15%.
- Trial name
- NCT02603055
- Testing
- 30μg/0.5ml Hepatitis E vaccine, 30μg/0.5ml Recombinant Hepatitis E vaccine
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
Hepatitis E Infection, Hepatitis; Epidemic
Hepatitis E Virus Infection in Oncological Patients
The goal of this clinical trial is to investigate the prevalence of hepatitis E infection in oncological patients in a rural region of Germany.
- Conditions
- Hepatitis E Infection, Hepatitis; Epidemic, Oncologic Disorders
- Trial name
- HepE-Onko-BB (NCT06631560)
- Testing
- ELISA testing
- Where
- Germany
- Volunteers
- 197 people, healthy volunteers welcome
- Sponsor
- Medizinische Hochschule Brandenburg Theodor Fontane
Hepatitis E
Exposure to Hepatitis E Virus in Occitania, France
The objective of the proposed work is to determine the seroprevalence of HEV in 2023 in a population of blood donors living in Occitania. Compare the current frequency of anti-HEV IgG and IgM markers with that of 2011.
- Trial name
- EVE (NCT06137313)
- Testing
- questionnaire
- Where
- France
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- University Hospital, Toulouse
Hepatitis E
Clinical Trial of Recombinant Hepatitis E Vaccine
The primary purpose of this study is to determine whether the preventive hepatitis E are effective in the prevention of hepatitis E occurring at least 30 days after the administration of the third dose of vaccine.
- Trial name
- NCT01014845
- Testing
- hepatitis E vaccine, Hepatitis B vaccine
- Where
- China
- Volunteers
- 112,604 people, healthy volunteers welcome
- Sponsor
- Xiamen University
Dengue, Chikungunya
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
RACSMEI addresses the high burden of infectious diseases in low- and middle-income countries, including Cambodia, where limited surveillance and laboratory capacity often obscure etiologies and transmission dynamics.
- Conditions
- Dengue, Chikungunya, Zika Virus Infection, Japanese Encephalitis
- Trial name
- RACSMEI (NCT07358910)
- Where
- Cambodia
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur du Cambodge
Hepatitis E, Hepatitis B
A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(Coadministration With Recombinant Hepatitis B Vaccine)
This is a open label, randomized phase VI study, to assess the safety and immunogenicity of co-administration of Hepatitis E vaccine with Hepatitis B vaccine.
- Trial name
- NCT02584543
- Testing
- HEV vaccine, HBV vaccine
- Where
- China
- Volunteers
- 602 people, healthy volunteers welcome
- Sponsor
- Xiamen Innovax Biotech Co., Ltd
Hepatitis E
Safety and Immunogenicity Study of Thiomersal-free Hepatitis E Vaccine in People Ages 16 Years and Above
The purpose of this study is to evaluate the safety and non-inferior immunogenicity of thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli) compared with licensed Recombinant Hepatitis E Vaccine (Escherichia Coli)…
- Trial name
- NCT06564116
- Testing
- Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli), Recombinant Hepatitis E Vaccine (Escherichia Coli)
- Where
- China
- Volunteers
- 612 people, healthy volunteers welcome
- Sponsor
- Xiamen Innovax Biotech Co., Ltd
HIV-1-infection, Hepatitis C, Chronic
Switch to Genvoya Followed by HCV Therapy With Epclusa Followed by Simplification of HIV Therapy With Biktarvy in Patients With HIV-HCV Co-Infected Subjects on Opioid Substitution Therapy
The study hypothesis is to determine the feasibility of switching HIV-HCV co-infected patients receiving methadone or buprenorphine/naloxone as opioid substitution therapy with suppressed HIV RNA viral load on current…
- Conditions
- HIV-1-infection, Hepatitis C, Chronic, Methadone Dependence, Opioid Dependence
- Trial name
- NCT03549312
- Testing
- Genvoya, Epclusa, Biktarvy
- Where
- Canada
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Saskatchewan Health Authority - Regina Area
Chronic Hepatitis B
Phase 1 Study of HT-102 Administered Subcustaneously in Healthy Participants and Patients With Chronic Hepatitis B for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102 (BM012) Injection in Healthy Subjects and Hepatitis B e Antigen-Negative Patients with Chronic Hepatitis B Virus Infection: A Randomized…
- Trial name
- NCT06744686
- Testing
- HT-102
- Where
- 7 sites in China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Suzhou HepaThera Biotech Co., Ltd.
Hepatitis E, Immunisation
Safety Study of Hepatitis E Vaccine (HEV239)
This is a Phase I double-blind, randomized, placebo controlled trial (1:4 ratio of placebo to vaccine) of Hepatitis E virus vaccine containing a 239 amino acid subfragment of Hecolin(R) (HEV-239) in 25 US males and non-pregnant…
- Trial name
- NCT03827395
- Testing
- HEV 239
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cervical Intraepithelial Neoplasia, Cervical Cancer
Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent（Type 16/18 ）Vaccine
This is a Phase III clinical trial of the novel recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD.
- Conditions
- Cervical Intraepithelial Neoplasia, Cervical Cancer, Vaginal Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia
- Trial name
- NCT01735006
- Testing
- HPV Vaccine, HEV vaccine
- Where
- China
- Volunteers
- 7,372 people, healthy volunteers welcome
- Sponsor
- Xiamen University