A Phase 4 interventional study of Recombinant Hepatitis E Vaccine (Escherichia Coli) in Hepatitis E, sponsored by Xiamen Innovax Biotech Co., Ltd. Completed at 1 site in China. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-25.
Sponsored by Xiamen Innovax Biotech Co., Ltd · Phase 4, Interventional, and Prevention
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.
37 studies on the registry are indexed under Hepatitis E; 9 are open to participants now.
This study's enrollment of 475 is above the median of 330 across 26 interventional studies indexed under Hepatitis E.
Browse Hepatitis E studies →Xiamen Innovax Biotech Co., Ltd is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria(all volunteers):
Inclusion Criteria(experiment group):
Inclusion Criteria(control group):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)
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.
Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)
Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Also known as: Hecolin®
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.
Time frame: 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.
Time frame: Month 7
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0-Month 7
| Milestone | the Chronic Hepatitis B Patients | the Healthy Volunteer |
|---|---|---|
| Started | 235 | 240 |
| Completed | 192 | 196 |
| Not completed | 43 | 44 |
Measure the number of participants whose anti-HEV antibody seroconverted at month 7 to evaluate the immunogenicity of the Hepatitis E vaccine.
| Participants | the Chronic Hepatitis B Patients | the Healthy Volunteer |
|---|---|---|
| Number of Participants Whose Anti-HEV Antibody Seroconverted at One Month After The Third Dose | 188 | 196 |
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.
| Wu/ml | the Chronic Hepatitis B Patients | the Healthy Volunteer |
|---|---|---|
| Geometric Mean Concentrations of Anti-HEV Antibody at One Month After The Third Dose | 11.89 (9.86 to 14.35) | 17.35 (15.57 to 19.34) |
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.
| Participants | the Chronic Hepatitis B Patients | the Healthy Volunteer |
|---|---|---|
| ALT — no change | 208 | 215 |
| ALT — processed | 5 | 4 |
| ALT — improved | 10 | 1 |
| AST — no change | 186 | 211 |
| AST — processed | 18 | 5 |
| AST — improved | 19 | 4 |
| TBIL — no change | 184 | 169 |
| TBIL — processed | 12 | 25 |
| TBIL — improved | 27 | 26 |
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.
| Participants | the Chronic Hepatitis B Patients | the Healthy Volunteer |
|---|---|---|
| ALT — no change | 204 | 206 |
| ALT — processed | 2 | 0 |
| ALT — improved | 7 | 0 |
| AST — no change | 178 | 203 |
| AST — processed | 8 | 2 |
| AST — improved | 27 | 1 |
| TBIL — no change | 182 | 195 |
| TBIL — processed | 6 | 1 |
| TBIL — improved | 25 | 10 |
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.
| Participants | the Chronic Hepatitis B Patients | the Healthy Volunteer |
|---|---|---|
| ALT — no change | 199 | 204 |
| ALT — processed | 1 | 0 |
| ALT — improved | 13 | 2 |
| AST — no change | 177 | 200 |
| AST — processed | 8 | 2 |
| AST — improved | 28 | 4 |
| TBIL — no change | 175 | 162 |
| TBIL — processed | 5 | 1 |
| TBIL — improved | 33 | 43 |
Any adverse reactions/events contains solicited and unsolicited adverse reactions/events during the whole period of observation.
| Participants | the Chronic Hepatitis B Patients | the Healthy Volunteer |
|---|---|---|
| Number of Participants Who Experienced Any Adverse Reactions/Events | 92 | 97 |
Number of participants who experienced local, system adverse reactions/events within 7 days after each vaccination.
| Participants | the Chronic Hepatitis B Patients | the Healthy Volunteer |
|---|---|---|
| Number of Participants Who Experienced Solicited Adverse Reactions/Events | 42 | 40 |
Number of participants who experienced solicited local adverse reactions/events within 7 days after each vaccination.
| Participants | the Chronic Hepatitis B Patients | the Healthy Volunteer |
|---|---|---|
| Number of Participants Who Experienced Solicited Local Adverse Reactions/Events | 17 | 17 |
Number of participants who experienced solicited system adverse reactions/events within 7 days after each vaccination.
| Participants | the Chronic Hepatitis B Patients | the Healthy Volunteer |
|---|---|---|
| Number of Participants Who Experienced Solicited System Adverse Reactions/Events | 31 | 28 |
Number of participants who experienced unsolicited adverse reactions/events during the whole period of observation.
| Participants | the Chronic Hepatitis B Patients | the Healthy Volunteer |
|---|---|---|
| Number of Participants Who Experienced Unsolicited Adverse Reactions/Events | 68 | 70 |
Collected over 0-7 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| the Chronic Hepatitis B Patients | 1/235 (0.4%) | 6/235 (2.6%) | 15/235 (6.4%) |
| the Healthy Volunteer | 0/240 (0%) | 2/240 (0.8%) | 19/240 (7.9%) |
| Event | the Chronic Hepatitis B Patients | the Healthy Volunteer |
|---|---|---|
| HypertensionCardiac disorders | 1/235 | 0/240 |
| subacute thyroiditisEndocrine disorders | 1/235 | 0/240 |
| upper gastrointestinal hemorrhageGastrointestinal disorders | 1/235 | 0/240 |
| myocardial infarctionCardiac disorders | 1/235 | 0/240 |
| cerebral infarctionNervous system disorders | 1/235 | 0/240 |
| VertebrobasilarArtery InsufficiencyNervous system disorders | 1/235 | 1/240 |
| lung cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/235 | 1/240 |
| Event | the Chronic Hepatitis B Patients | the Healthy Volunteer |
|---|---|---|
| pyrexiaGeneral disorders | 15/235 | 19/240 |
| Age, Continuous(years) | the Chronic Hepatitis B Patients | the Healthy Volunteer | Total |
|---|---|---|---|
| Mean | 53.4 ± 9.7 | 53.4 ± 9.5 | 53.4 ± 9.6 |
| Sex: Female, Male(Participants) | the Chronic Hepatitis B Patients | the Healthy Volunteer | Total |
|---|---|---|---|
| Female | 96 | 97 | 193 |
| Male | 139 | 143 | 282 |
| Race and Ethnicity Not Collected(Participants) | the Chronic Hepatitis B Patients | the Healthy Volunteer | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Escherichia coli
Xiamen Innovax Biotech Co., Ltd