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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000368437

Enrollment

600

Registered

2007-07-13

Start date

2005-01-07

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

16 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy; willing to comply the protocol; have not been adminastrated with any other preventive products such as vaccine or immunoglobulin.

Exclusion criteria

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.

Outcome results