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

NCT06564116 | Completed Phase 4

• 1 other identifier: PRO-HE-011
• Study Type: interventional
• Target: 612
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis E

Keywords

Hepatitis E; Hepatitis E vaccine; Thiomersal

Outcome Measures

Primary Outcomes (5)

• 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.

  Month 7

• Anti-HEV IgG geometric mean concentration (GMC) at Month 7

  Measure anti-HEV IgG antibody GMC at Month 7.

  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.

  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.

  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.

  Month 12

Study Arms (2)

Test Group

EXPERIMENTAL

Thiomersal-free hepatitis E vaccine

Biological: Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli)

Control Group

ACTIVE COMPARATOR

Licensed hepatitis E vaccine

Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)

Interventions

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.

Test Group

Recombinant Hepatitis E Vaccine (Escherichia Coli) BIOLOGICAL

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

Control Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Xiamen Innovax Biotech Co., Ltd: lead
• Center for Disease Control and Prevention, Fujian: collaborator

Study Sites (1)

Youxi County Center for Disease Control and Prevention

Sanming, Fujian, China

Location

Related Publications (1)

• 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.

  PMID: 40690851 DERIVED

MeSH Terms

Conditions

Hepatitis E

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Dongjuan Zhang

  Center for Disease Control and Prevention, Fujian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: March 22, 2023
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)