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

NCT ID: NCT06564116

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 612 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-22
• Study Completion Date: 2024-03-28

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Test Group

Thiomersal-free hepatitis E vaccine

Group Type: EXPERIMENTAL

Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli)

Intervention Type: BIOLOGICAL

Participants would receive 3 doses of thiomersal-free hepatitis E vaccine intramuscularly at month 0, 1 and 6.

Control Group

Licensed hepatitis E vaccine

Group Type: ACTIVE_COMPARATOR

Recombinant Hepatitis E Vaccine (Escherichia Coli)

Intervention Type: BIOLOGICAL

Participants would receive 3 doses of licensed hepatitis E vaccine intramuscularly at month 0, 1 and 6

Interventions

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.

Intervention Type: BIOLOGICAL

Recombinant Hepatitis E Vaccine (Escherichia Coli)

Participants would receive 3 doses of licensed hepatitis E vaccine intramuscularly at month 0, 1 and 6

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Aged 16 years and above when administered with the first dose of vaccine;

2. Axillary temperature is 37.2 ℃ or less;

3. Clinically determined as healthy and eligible for vaccination by the investigators after inquiring about the medical history and relevant physical examinations;

4. 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;

5. Able to comply with the request of study protocol and complete every visit;

6. Females with negative urine pregnancy test results;

7. Negative serological markers for hepatitis E (HEV-Ab).

Exclusion Criteria

1. Females who are pregnant or breastfeeding, or planning to be pregnant within the next 8 months;

2. Administration of hepatitis E vaccine before the study;

3. 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;

4. 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);

5. 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;

6. 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;

7. 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;

8. Plan to participate in any other clinical trial during the study period;

9. 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);

10. 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.

11. Asthma that needed emergency treatment, hospitalization, oral or intravenous corticosteroid to keep stable in the past two years;

12. Complicated with another severe internal disease(such as hypertension, cardiopathy, diabetes and hyperthyroidism etc);

13. Abnromal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or coagulopathy diagnosed by the doctor;

14. 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;

15. 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;

16. 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;

17. Individuals without civil capacity.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Center for Disease Control and Prevention, Fujian

OTHER

Sponsor Role: collaborator

Xiamen Innovax Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dongjuan Zhang

Role: PRINCIPAL_INVESTIGATOR

Center for Disease Control and Prevention, Fujian

Locations

Youxi County Center for Disease Control and Prevention

Sanming, Fujian, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40690851 (View on PubMed)

Other Identifiers

PRO-HE-011

Identifier Type: -

Identifier Source: org_study_id