Hepatitis EPhase 4NCT06564116

Safety and Immunogenicity Study of Thiomersal-free Hepatitis E Vaccine in People Ages 16 Years and Above

A Phase 4 study testing Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli) and Recombinant Hepatitis E Vaccine (Escherichia Coli) in people with Hepatitis E, run by Xiamen Innovax Biotech Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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) when administered in participants ages 16 years and above. Read more about this study

Who is it for?: Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for: Hepatitis E
What is being tested?: Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli) and Recombinant Hepatitis E Vaccine (Escherichia Coli)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 612 participants
Where: 1 siteChina
Study dates: 22 Mar 2023to 28 Mar 2024
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Aged 16 years and above when administered with the first dose of vaccine;
Axillary temperature is 37.2 ℃ or less;
Clinically determined as healthy and eligible for vaccination by the investigators after inquiring about the medical history and relevant physical examinations;
Willing to participate in this study and sign informed consent form (ICF). Participants aged 16-17 years should sign ICF jointly by themselves and their guardians;
Able to comply with the request of study protocol and complete every visit;
Females with negative urine pregnancy test results;
Negative serological markers for hepatitis E (HEV-Ab).

Who cannot join

Females who are pregnant or breastfeeding, or planning to be pregnant within the next 8 months;
Administration of hepatitis E vaccine before the study;
Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period;
Long-term (for more than 14 days) use of immunosuppressant, immunoregulation therapy or corticosteroid systemic therapy within 6 months before the first dose of the study vaccine, excluding local treatment ( such as ointment, eye drops, inhalants or nasal sprays);
Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine, or plan to use during the study period;
Administration of any inactivated vaccines within 14 days preceding enrollment (other vaccines besides live-attenuated vaccines, including recombinant vaccines, subunit vaccines, polysaccharide conjugate vaccines, synthetic peptide vaccines, etc ), or live-attenuated vaccines within 28 days preceding enrollment;

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Had a fever (axillary temperature is 38.0℃ or higher) within 3 days prior to, or any acute illness requiring systemic antibiotics or antiviral treatment within 5 days prior to vaccination;
Plan to participate in any other clinical trial during the study period;
Immunodeficiency disorders, subjects with primary diseases of important organs, cancer or precancerous lesions, or any immune disease requiring treatment (such as systemic lupus erythematosus, rheumatoid arthritis, any condition resulting in asplenectomy or splenectomy, and other immune diseases that researchers believe may have an impact on the immune response);
Have a history of severe allergies, including history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain.
Asthma that needed emergency treatment, hospitalization, oral or intravenous corticosteroid to keep stable in the past two years;
Complicated with another severe internal disease(such as hypertension, cardiopathy, diabetes and hyperthyroidism etc);
Abnromal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or coagulopathy diagnosed by the doctor;
Epilepsy, excluding febrile seizures under 2 years old, alcoholic seizures within 3 years before abstinence, or simple epilepsy without treatment in the past 3 years;
Inability to comply with the study requirement due to psychological conditions, past or present severe mental disorders that have not been well controlled within the past 2 years, accident-causing behavior, or having suicidal tendencies in the past 5 years;
Other medical, psychological, social or occupational factors that, according to the investigators' judgment, which are inconsistent with the study protocol or affecting the subjects and/or guardians (trustees) to sign the informed consent;
Individuals without civil capacity.

Trial locations and contacts

1 site in 1 country.

China1 site

Youxi County Center for Disease Control and Prevention
Sanming, Fujian

Other trials in China

About this study

Official title: A Randomized, Double-blind, Active Comparator Clinical Trial to Evaluate Safety and Immunogenicity of Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli) in People Ages 16 Years and Above

Read the detailed description

This is a single-center, randomized, double-blind, active-comparator study to evaluate the safety and immunogenicity of thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli) in participants ages 16 years and above. Sex (male, female) and age (16-40 years old, 41 years old and above) are used as stratified factors. Participants are randomly assigned in a 1:1 ratio to receive three doses of thiomersal-free hepatitis E vaccine or licensed hepatitis E vaccine intramuscularly at Month 0, 1 and 6. The vaccine safety is assessed from the 1st dose vaccination to 6 months after the last dose vaccination. Serum samples are collected for anti-HEV IgG determination at Month 0 and 7.

Conditions: Hepatitis E
Being tested: Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli), Recombinant Hepatitis E Vaccine (Escherichia Coli)
Keywords: Hepatitis E, Hepatitis E vaccine, Thiomersal
Medical subject headings: Hepatitis E

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli)Biological
Participants would receive 3 doses of thiomersal-free hepatitis E vaccine intramuscularly at month 0, 1 and 6.
Recombinant Hepatitis E Vaccine (Escherichia Coli)Biological
Participants would receive 3 doses of licensed hepatitis E vaccine intramuscularly at month 0, 1 and 6

Study groups in NCT06564116
Study group	Role	What they receive
Test Group	Experimental	Thiomersal-free hepatitis E vaccine Receives: Biological: Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli)
Control Group	Active comparator	Licensed hepatitis E vaccine Receives: Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)

What is being measured

The primary outcome is the main question the study is designed to answer.

Seroconversion rate of anti-HEV IgG at Month 7
The percentage of participants who had ≥4-fold rise in anti-HEV IgG antibody from baseline to Month 7.
Measured: Month 7
Anti-HEV IgG geometric mean concentration (GMC) at Month 7
Measure anti-HEV IgG antibody GMC at Month 7.
Measured: Month 7
Adverse events within 0-7 days after each vaccination
Measure percentage of participants reporting adverse events within 0-7 days after each vaccination.
Measured: Day 7
Adverse events within 8-30 days after each vaccination
Measure percentage of participants reporting adverse events within 8-30 days after each vaccination.
Measured: Day 30
Serious adverse events and pregnancy from the 1st dose vaccination to 6 months after the last vaccination
Measure percentage of participants reporting serious adverse events and pregnancy from the 1st dose vaccination to 6 months after the last vaccination.
Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 202328 Mar 2024

First posted21 Aug 2024
Study start22 Mar 2023
Primary completion28 Mar 2024
Study completion28 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis EStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 612 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06564116
Sponsor's protocol ID: PRO-HE-011
Status last verified: Aug 2024
First submitted: 19 Aug 2024
Last updated: 21 Aug 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Li J, Wang X, Zhang D, Xie F, Zhong S, Yu X, Chen S, Huang Q, Wang R, Zhang Q, Zhang D. Safety and immunogenicity of thiomersal-free recombinant hepatitis E vaccine: A randomized, double-blind, active-controlled study. Vaccine. 2025 Aug 30;62:127510. doi: 10.1016/j.vaccine.2025.127510. Epub 2025 Jul 20.
PubMed 40690851

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatitis E trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Active Comparator Clinical Trial to Evaluate Safety and Immunogenicity of Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli) in People Ages 16 Years and Above
ClinicalTrials.gov ID: NCT06564116
Acronym / sponsor ID: PRO-HE-011
Conditions: Hepatitis E
Keywords: Hepatitis E, Hepatitis E vaccine, Thiomersal
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 612 participants (actual)
Lead sponsor: Xiamen Innovax Biotech Co., LtdIndustry (pharma, biotech, devices)
Collaborators: Center for Disease Control and Prevention, Fujian
Study start: 22 Mar 2023 (actual)
Primary completion: 28 Mar 2024 (actual)
Study completion: 28 Mar 2024 (actual)
First posted: 21 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Test Group	Experimental	Biological: Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli)Thiomersal-free hepatitis E vaccine
Control Group	Active comparator	Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)Licensed hepatitis E vaccine

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Aged 16 years and above when administered with the first dose of vaccine;
Axillary temperature is 37.2 ℃ or less;
Clinically determined as healthy and eligible for vaccination by the investigators after inquiring about the medical history and relevant physical examinations;
Willing to participate in this study and sign informed consent form (ICF). Participants aged 16-17 years should sign ICF jointly by themselves and their guardians;
Able to comply with the request of study protocol and complete every visit;

Key exclusion criteria (17 listed)

Females who are pregnant or breastfeeding, or planning to be pregnant within the next 8 months;
Administration of hepatitis E vaccine before the study;
Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period;
Long-term (for more than 14 days) use of immunosuppressant, immunoregulation therapy or corticosteroid systemic therapy within 6 months before the first dose of the study vaccine, excluding local treatment ( such as ointment, eye drops, inhalants or nasal sprays);
Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine, or plan to use during the study period;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli)Participants would receive 3 doses of thiomersal-free hepatitis E vaccine intramuscularly at month 0, 1 and 6.	Biological	Test Group
Recombinant Hepatitis E Vaccine (Escherichia Coli)Participants would receive 3 doses of licensed hepatitis E vaccine intramuscularly at month 0, 1 and 6	Biological	Control Group

Primary outcome

Seroconversion rate of anti-HEV IgG at Month 7
Time frame: Month 7
The percentage of participants who had ≥4-fold rise in anti-HEV IgG antibody from baseline to Month 7.
Anti-HEV IgG geometric mean concentration (GMC) at Month 7
Time frame: Month 7
Measure anti-HEV IgG antibody GMC at Month 7.
Adverse events within 0-7 days after each vaccination
Time frame: Day 7
Measure percentage of participants reporting adverse events within 0-7 days after each vaccination.
Adverse events within 8-30 days after each vaccination
Time frame: Day 30
Measure percentage of participants reporting adverse events within 8-30 days after each vaccination.
Serious adverse events and pregnancy from the 1st dose vaccination to 6 months after the last vaccination
Time frame: Month 12
Measure percentage of participants reporting serious adverse events and pregnancy from the 1st dose vaccination to 6 months after the last vaccination.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
Derived from this study: PubMed 40690851Li J, Wang X, Zhang D, Xie F, Zhong S, Yu X, Chen S, Huang Q, Wang R, Zhang Q, Zhang D. Safety and immunogenicity of thiomersal-free recombinant hepatitis E vaccine: A randomized, double-blind, active-controlled study. Vaccine. 2025 Aug 30;62:127510. doi: 10.1016/j.vaccine.2025.127510. Epub 2025 Jul 20.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dongjuan Zhang principal investigator

Center for Disease Control and Prevention, Fujian

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion rate of anti-HEV IgG at Month 7 (time frame: Month 7). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06564116, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.