A Phase 4 interventional study of Recombinant (E. Coli) Hepatitis E Vaccine in Hepatitis E, sponsored by Jun Zhang. Completed at 1 site in China. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-17.
Sponsored by Jun Zhang · Phase 4, Interventional, and Prevention
Among 11 studies in Hepatitis E with a site in China — 1 open to participants now, 1 under way, none of them phase 3. Hepatitis E · China.
Among the 11 studies in Hepatitis E with a site in China, this one is the 4th largest by enrollment of the 10 interventional ones, is the only one that started in 2014, is one of 8 in phase 4, and was the 2nd registered.
37 studies on the registry are indexed under Hepatitis E; 9 are open to participants now.
This study's enrollment of 601 is above the median of 330 across 26 interventional studies indexed under Hepatitis E.
Browse Hepatitis E studies →1 of the 11 studies in Hepatitis E with a site in China is open now, in 1 country. Each count lists the studies.
Of the 7 Hepatitis E studies recruiting now, 1 (14%) set no upper age limit and 5 (71%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.
This study: 16 Years and older · all sexes · healthy volunteers too.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2014.
Median enrollment 540 across the 10 interventional studies, 2,900 across the 1 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.
7 of 11 have an industry lead sponsor. The 4 most frequent:
Jun Zhang is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
Jun Zhang has 1 study filed under Hepatitis E — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Hepatitis E with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
For dose 1:
For dose 2 or 3:
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.
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-HEV IgG seronegative participants over 65 years old were enrolled. Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses.
Biological: Recombinant (E. Coli) Hepatitis E Vaccine
Participants aged 16-65 years old were enrolled. Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses.
Biological: Recombinant (E. Coli) Hepatitis E Vaccine
Anti-HEV IgG seropositive participants over 65 years old were enrolled. This is the safety control group, without any intervention.
Also known as: Hecolin®
Number of Participants with Serious and Non-Serious Adverse Events
Any adverse events reported within one month post each vaccination would be recorded, any serious adverse events reported throughout the study would be recorded.
Time frame: From month 0-7
anti-HEV IgG seropositive rate
Time frame: at month 7
GMT of anti-HEV IgG
Serum sample would be collected at month 7, and geometric mean titer of anti-HEV IgG would be tested
Time frame: 7 month after first vaccination
The record gives a start of Jun 2014, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Escherichia coli
Jun Zhang