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CompletedPhase 2ACTRN12607000368437

Safety and Immunogenecity Study of an E.Coli Expressed Particulate Recombinant Hepatitis E Vaccine

Sponsor

Xiamen YangShengTang Biotechnic Ltd.

Enrollment

600 participants

Start Date

Jan 7, 2005

Study Type

Interventional

Conditions

Hepatitis E

Summary

The primary purpose of the protocol is to evaluate the safety and immunogenicity of an E.coli expressed particulate recombinant hepatitis E vaccine. The study hypothesis is that the vaccine induce significant seroconversion of IgG anti-HEV in healthy subjects, and the vaccine is tolerable for healthy adults.

Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates Safety and Immunogenecity Study of an E.Coli Expressed Particulate Recombinant Hepatitis E Vaccine. It is looking for both men and women, aged 16 to 55 who have healthy; willing to comply the protocol; have not been adminastrated with any other preventive products such as vaccine or immunoglobulin. People who are pregnant or breastfeeding individuals cannot take part. If you are interested, you may need to attend study visits and follow the research team's instructions.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention: hepatitis E (HE) vaccine The subjects were randomized and assigned to groups to administrate intramuscular injection either two 20µg HE vaccine doses (0 month, 6th month), three 10µg, 2

Intervention: hepatitis E (HE) vaccine The subjects were randomized and assigned to groups to administrate intramuscular injection either two 20µg HE vaccine doses (0 month, 6th month), three 10µg, 20µg, 30µg or 40 µg of HE vaccine 20 µg dose (0 month, 1st month, 6th month) respectively. Participants received intervention treatment or control treatment will be followed-up for 1 month after the last vaccination.

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ACTRN12607000368437

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