Phase 2 Trial of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine (Mimogen-based) in Treating Chronic Hepatitis B Patients
1 other identifier
interventional
360
1 country
15
Brief Summary
The purpose is to evaluate efficacy and safety of therapeutic Hepatitis B Virus（HBV） vaccine (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2009
Typical duration for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2009
CompletedFirst Posted
Study publicly available on registry
March 26, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
January 18, 2017
CompletedOctober 1, 2019
September 1, 2019
2.6 years
March 25, 2009
November 20, 2016
September 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With HBeAg Seroconversion at Endpoint .
Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)
Endpoint(LOCF), up to 76 Weeks
Secondary Outcomes (9)
Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76
serology response at week 12, 28, 32, 40, 52, 64, 76
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 1 Log Scale;
week 12, 28, 32, 40, 52, 64, 76
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76
week 12, 28, 32, 40, 52, 64, 76
The Proportion of Patients With Both Negative HBeAg and HBeAb;
at week 12, 28, 32, 40, 52, 64, 76.
The Proportion of Patients With Positive Anti-HBe
at week 12, 28, 32, 40, 52, 64, 76.
- +4 more secondary outcomes
Study Arms (3)
εPA-44 900μg
EXPERIMENTALInject εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
εPA-44 600μg+Placebo 300μg
EXPERIMENTALInject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
Placebo 900μg
PLACEBO COMPARATORInject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
Interventions
Eligibility Criteria
You may qualify if:
- Aged 18-65 years, male or female
- Conforms to diagnosis standard of chronic hepatitis B according to"2005 Guideline for Prevention and Treatment of Hepatitis B", (with positive HBsAg for more than 6 months), and HBV-DNA more than 100000 copies/ml;HBeAg (+),HBsAb(-); Alanine aminotransferase（ALT） within 2 to 10 times of ULN (upper limit of normal)
- HLA-A2 positive
- Compensatory liver disease having following hematological and biochemical indicators:WBC≥3.5E+9/L; ANC≥1.5E+9/L; PLT≥80E+9/L; Hb≥110g/L; TBil≤1.5ULN; ALB ≥ lower limit of normal value; BUN (Urea)≤upper limit of normal value; Cr≤upper limit of normal value; prothrombin time(PT) elongation≤3 sec; Activated partial thromboplastin time（APTT） within normal value; Fasting blood glucose≤7.0mmol/L
- TSH within normal value
- AFP ≤20ng/ml
- Uses effective contraception for subject with child-bearing potential (including females and female partners of males)
- Understands and signs ICF approved by EC
- Willing to comply with the study procedures and complete the study
You may not qualify if:
- Antibody of HAV IgM, HCV, HDV IgM or HEV IgM is positive
- Antibody of CMV IgM, EBV IgM or HIV is positive
- Antinuclear antibody titer\>1:160
- Hepatocarcinoma, suspected hepatocarcinoma or hepatic cirrhosis
- Has any of the following illnesses or has a severe disease inappropriate for participation in the study based on the investigator's judgment, such as: Cardiovascular system: instable or significant cardiovascular illness such as angina pectoris, heart attack of myocardial infarction, congestive heart failure, severe hypertension, significant arrhythmia or abnormal ECG etc.; Respiratory system: bronchiectasis, bronchial asthma, chronic obstructive pulmonary disease, respiratory failure, etc.; Endocrine, metabolism diseases: diabetes mellitus, uncontrolled thyroid diseases, etc.; Others: autoimmune disorder, active tuberculosis, malignancies (e.g.tumor), neuropathic or metal illness history,etc.
- Has used anti-HBV drug (Interferon, Lamivudine, Adefovir Dipivoxil, Entecavir and Telbivudine) and immunomodulator (Thymic peptide,etc ) 6 months prior to the administration of study medication
- Has participated in any other drug clinical investigations within the past 3 months
- Has allergy habitus or has suspected allergy to study drug
- Female who is in pregnancy, in lactation or planning to become pregnant during the course of the study
- Has a history of alcohol abuse (Alcohol consumption for more than 5 years, with daily consumption over 40g for males and over 20g for females) and known drug dependence
- Has a history of organ transplant (except external corneal transplantation and hair transplantation)
- Any other factors inappropriate for enrollment in the study or study completion in the view of the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
The PLA Beijing Military General Hospital
Beijing, Beijing Municipality, China
The 2nd Affiliated Hosptial of Harbin Medical University
Harbin, Heilongjiang, China
Renmin Hosptial of Wuhan University
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
81th Hospital of PLA
Nanjing, Jiangsu, China
Jilin University First Hospital
Changchun, Jilin, China
TangDu Hospital
XiAn, Shanxi, China
The First Affiliated Hospital of Xi'An JiaoTong University
Xi’an, Shanxi, China
West China Hospital,SiChuan University
Chengdu, Sichuan, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
302 Militray Hosptial of China
Beijing, China
Hepatitis Institute of Peking University People's Hospital
Beijing, China
Southwest Hospital
Chongqing, China
Related Publications (1)
Wei L, Zhao T, Zhang J, Mao Q, Gong G, Sun Y, Chen Y, Wang M, Tan D, Gong Z, Li B, Niu J, Li S, Gong H, Zou L, Zhou W, Jia Z, Tang Y, Fei L, Hu Y, Shang X, Han J, Zhang B, Wu Y. Efficacy and safety of a nanoparticle therapeutic vaccine in patients with chronic hepatitis B: A randomized clinical trial. Hepatology. 2022 Jan;75(1):182-195. doi: 10.1002/hep.32109. Epub 2021 Dec 8.
PMID: 34396571DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr.Wu
- Organization
- Institute of Immunology，PLA
Study Officials
- PRINCIPAL INVESTIGATOR
Lai Wei, Ph.D.
Hepatitis Institute of Peking University People's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2009
First Posted
March 26, 2009
Study Start
April 1, 2009
Primary Completion
November 1, 2011
Study Completion
May 1, 2013
Last Updated
October 1, 2019
Results First Posted
January 18, 2017
Record last verified: 2019-09