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

August 19, 2024 updated by: Xiamen Innovax Biotech Co., Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

612

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Sanming, Fujian, China
        • Youxi County Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group
Thiomersal-free hepatitis E vaccine
Biological: 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.
Active Comparator: Control Group
Licensed hepatitis E vaccine
Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)
Participants would receive 3 doses of licensed hepatitis E vaccine intramuscularly at month 0, 1 and 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
Day 7
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.
Day 30
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.
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiamen Innovax Biotech Co., Ltd

Collaborators

Center for Disease Control and Prevention, Fujian

Investigators

  • Principal Investigator: Dongjuan Zhang, Center for Disease Control and Prevention, Fujian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2023

Primary Completion (Actual)

March 28, 2024

Study Completion (Actual)

March 28, 2024

Study Registration Dates

First Submitted

August 19, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-HE-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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