Safety and Immunogenecity Study of an E.Coli Expressed Particulate Recombinant Hepatitis E Vaccine
Xiamen YangShengTang Biotechnic Ltd.
600 participants
Jan 7, 2005
Interventional
Conditions
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
Inclusion Criteria1
- Healthy; willing to comply the protocol; have not been adminastrated with any other preventive products such as vaccine or immunoglobulin.
Exclusion Criteria1
- Any anaphylaxis history to vaccination or medicine; any neurotic or mental disease history or family history; impediment of cruor; any confirmed or possible immuno-deficiency; any active infection; serious liver, kidney, or cardio-vascular diseases; malignant tumor, serious asthma; spleen removal; hypertension; pregnant or lactatation period woman; fever; antibody against hepatitis E virus (anti-HEV) positive; alanine transaminase abnormal; blood urea nitrogen abnormal; glucose abnormal; Hepatitis B virus surface antigen (HBsAg) positive.
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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, 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