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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.
This phase IV clinical study was designed to evaluate the immunogenicity and safety of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in the chronic Hepatitis B patients on the clinical stability and aged over 30 years of age at enrollment. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-1-6 month schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the chronic Hepatitis B patients | Experimental | Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at 0,1,6 month. |
|
| the healthy volunteer | Active Comparator | Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at 0,1,6 month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Hepatitis E Vaccine (Escherichia Coli) | Biological | Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Whose Anti-HEV Antibody Seroconverted at One Month After The Third Dose | Measure the number of participants whose anti-HEV antibody seroconverted at month 7 to evaluate the immunogenicity of the Hepatitis E vaccine. | Month 7 |
| Geometric Mean Concentrations of Anti-HEV Antibody at One Month After The Third Dose | Measure the level of anti-HEV antibody in serum samples at month 7 to evaluate the immunogenicity of the Hepatitis E vaccine. Wu/ml：World Health Organization (WHO) units per ml. The WHO standard was used to calibrate the antibody quantitative reference. | Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Changes in Liver Function Index Before and One Month After the First Dose | ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: "no change" indicated no grade change; "processed" indicated a change from normal to abnormal or an increase in grade; and "improved" indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal. |
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Inclusion Criteria(all volunteers):
Inclusion Criteria(experiment group):
Inclusion Criteria(control group):
1. HBsAg(-)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aiqiang Xu | Shandong Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rushan Center for Disease Control and Prevention | Weihai | Shandong | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | the Chronic Hepatitis B Patients | Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month. Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month. |
| FG001 | the Healthy Volunteer | Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month. Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | the Chronic Hepatitis B Patients | Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month. Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Whose Anti-HEV Antibody Seroconverted at One Month After The Third Dose | Measure the number of participants whose anti-HEV antibody seroconverted at month 7 to evaluate the immunogenicity of the Hepatitis E vaccine. | Totally 192 CHB participants and 196 healthy participants were involved in per-protocol set, who meet the meet the requirements 1) whole-course inoculation, 2)having the results of anti-HEV antibody test before and after immunization, 3) anti-HEV antibody negative before immunization. | Posted | Count of Participants | Participants | Month 7 |
|
0-7 months
The definitions of "All-Cause Mortality","Serious Adverse Events" and "Adverse Events" are consistent with the clinicaltrials.gov Definitions.
One death was due to myocardial infarction.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | the Chronic Hepatitis B Patients | Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month. Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment | Grade 3: SBP≥180mmHg and\or DBP≥110mmHg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pyrexia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shandong Provincial Key Laboratory of Infectious Disease Control and Prevention | Shandong Center for Disease Control and Prevention, Jinan, China | 0531-82679606 | aqxuepi@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2018 | Jul 23, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016751 | Hepatitis E |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C577000 | hecolin |
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|
| Day 0-Month 1 |
| Number of Participants With Changes in Liver Function Index Before and One Month After the Third Dose | ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: "no change" indicated no grade change; "processed" indicated a change from normal to abnormal or an increase in grade; and "improved" indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal. | Month 6-Month 7 |
| Number of Participants With Changes in Liver Function Index Before The First Dose and One Month After the Third Dose | ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: "no change" indicated no grade change; "processed" indicated a change from normal to abnormal or an increase in grade; and "improved" indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal. | Day0-Month 7 |
| Number of Participants Who Experienced Any Adverse Reactions/Events | Any adverse reactions/events contains solicited and unsolicited adverse reactions/events during the whole period of observation. | Day 0-Month 7 |
| Number of Participants Who Experienced Solicited Adverse Reactions/Events | Number of participants who experienced local, system adverse reactions/events within 7 days after each vaccination. | Day 0-Day 7 |
| Number of Participants Who Experienced Solicited Local Adverse Reactions/Events | Number of participants who experienced solicited local adverse reactions/events within 7 days after each vaccination. | Day 0-Day 7 |
| Number of Participants Who Experienced Solicited System Adverse Reactions/Events | Number of participants who experienced solicited system adverse reactions/events within 7 days after each vaccination. | Day 0-Day 7 |
| Number of Participants Who Experienced Unsolicited Adverse Reactions/Events | Number of participants who experienced unsolicited adverse reactions/events during the whole period of observation. | Day 0-Month 7 |
| BG001 |
| the Healthy Volunteer |
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month. Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | the Healthy Volunteer | Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month. Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month. |
|
|
|
| Primary | Geometric Mean Concentrations of Anti-HEV Antibody at One Month After The Third Dose | Measure the level of anti-HEV antibody in serum samples at month 7 to evaluate the immunogenicity of the Hepatitis E vaccine. Wu/ml：World Health Organization (WHO) units per ml. The WHO standard was used to calibrate the antibody quantitative reference. | Totally 192 CHB participants and 196 healthy participants were involved in per-protocol set, who meet the meet the requirements 1) whole-course inoculation, 2)having the results of anti-HEV antibody test before and after immunization, 3) anti-HEV antibody negative before immunization. | Posted | Geometric Mean | 95% Confidence Interval | Wu/ml | Month 7 |
|
|
|
|
| Secondary | Number of Participants With Changes in Liver Function Index Before and One Month After the First Dose | ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: "no change" indicated no grade change; "processed" indicated a change from normal to abnormal or an increase in grade; and "improved" indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal. | All the participants who visited at one month after the first dose. | Posted | Count of Participants | Participants | Day 0-Month 1 |
|
|
|
| Secondary | Number of Participants With Changes in Liver Function Index Before and One Month After the Third Dose | ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: "no change" indicated no grade change; "processed" indicated a change from normal to abnormal or an increase in grade; and "improved" indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal. | All the participants who visited at one month after the third dose. | Posted | Count of Participants | Participants | Month 6-Month 7 |
|
|
|
| Secondary | Number of Participants With Changes in Liver Function Index Before The First Dose and One Month After the Third Dose | ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: "no change" indicated no grade change; "processed" indicated a change from normal to abnormal or an increase in grade; and "improved" indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal. | All the participants who visited at one month after the third dose. | Posted | Count of Participants | Participants | Day0-Month 7 |
|
|
|
| Secondary | Number of Participants Who Experienced Any Adverse Reactions/Events | Any adverse reactions/events contains solicited and unsolicited adverse reactions/events during the whole period of observation. | All the participants who received at least one injection. | Posted | Count of Participants | Participants | Day 0-Month 7 |
|
|
|
|
| Secondary | Number of Participants Who Experienced Solicited Adverse Reactions/Events | Number of participants who experienced local, system adverse reactions/events within 7 days after each vaccination. | All the participants who received at least one injection. | Posted | Count of Participants | Participants | Day 0-Day 7 |
|
|
|
|
| Secondary | Number of Participants Who Experienced Solicited Local Adverse Reactions/Events | Number of participants who experienced solicited local adverse reactions/events within 7 days after each vaccination. | All the participants who received at least one injection. | Posted | Count of Participants | Participants | Day 0-Day 7 |
|
|
|
|
| Secondary | Number of Participants Who Experienced Solicited System Adverse Reactions/Events | Number of participants who experienced solicited system adverse reactions/events within 7 days after each vaccination. | All the participants who received at least one injection. | Posted | Count of Participants | Participants | Day 0-Day 7 |
|
|
|
|
| Secondary | Number of Participants Who Experienced Unsolicited Adverse Reactions/Events | Number of participants who experienced unsolicited adverse reactions/events during the whole period of observation. | All the participants who received at least one injection. | Posted | Count of Participants | Participants | Day 0-Month 7 |
|
|
|
|
| 1 |
| 235 |
| 6 |
| 235 |
| 15 |
| 235 |
| EG001 | the Healthy Volunteer | Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month. Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month. | 0 | 240 | 2 | 240 | 19 | 240 |
|
| subacute thyroiditis | Endocrine disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| upper gastrointestinal hemorrhage | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| myocardial infarction | Cardiac disorders | Other | Non-systematic Assessment |
|
| cerebral infarction | Nervous system disorders | Other | Non-systematic Assessment |
|
| VertebrobasilarArtery Insufficiency | Nervous system disorders | Other | Non-systematic Assessment |
|
| lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Other | Non-systematic Assessment |
|
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| D006505 |
| Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| improved |
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| AST |
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| TBIL |
|
| improved |
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| AST |
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| TBIL |
|
| improved |
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| AST |
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| TBIL |
|