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Trial registered on ANZCTR


Registration number
ACTRN12607000368437
Ethics application status
Approved
Date submitted
6/07/2007
Date registered
13/07/2007
Date last updated
13/07/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and Immunogenecity Study of an E.Coli Expressed Particulate Recombinant Hepatitis E Vaccine
Scientific title
Safety and Immunogenecity Study of an E.Coli Expressed Particulate Recombinant Hepatitis E Vaccine
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis E 1946 0
Condition category
Condition code
Inflammatory and Immune System 2043 2043 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 1878 0
Prevention
Comparator / control treatment
Control treatment: commercial hepatitis B vaccine
The subjects were randomly assigned to group to administrate intramuscular injection three 5µg commercial hepatitis B vaccine doses (0 month, 1st month, 6th month).
Control group
Active

Outcomes
Primary outcome [1] 2869 0
Seroconversion rate of immunoglobulin gamman (IgG) antibody against hepatitis E virus (HEV).
Timepoint [1] 2869 0
At one month after the last intervention
Secondary outcome [1] 4839 0
Level of IgG antibody against hepatitis E virus
Timepoint [1] 4839 0
At baseline and at 0, 1 and 7 months after the last intervention
Secondary outcome [2] 4840 0
Novel infection rate of hepatitis E virus
Timepoint [2] 4840 0
At 0, 1, and 7 months after the last intervention

Eligibility
Key inclusion criteria
Healthy; willing to comply the protocol; have not been adminastrated with any other preventive products such as vaccine or immunoglobulin.
Minimum age
16 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The people receiving the vaccines, the people administering the vaccination and the people assessing the outcomes were blinded.
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2185 0
Government body
Name [1] 2185 0
Ministry of Science and Technology of China
Country [1] 2185 0
China
Funding source category [2] 2186 0
Commercial sector/Industry
Name [2] 2186 0
Xiamen YangShengTang Biotechnic Ltd
Country [2] 2186 0
China
Primary sponsor type
Commercial sector/Industry
Name
Xiamen YangShengTang Biotechnic Ltd.
Address
Country
China
Secondary sponsor category [1] 1972 0
University
Name [1] 1972 0
National Institute of Diagnostics and Vaccine Development in infectious disease, Xiamen University
Address [1] 1972 0
Country [1] 1972 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3982 0
The institutional review boards of Guangxi Province-Liucheng county
Ethics committee address [1] 3982 0
Ethics committee country [1] 3982 0
China
Date submitted for ethics approval [1] 3982 0
Approval date [1] 3982 0
29/12/2004
Ethics approval number [1] 3982 0
IRB00001594
Ethics committee name [2] 3983 0
The institutional review boards of Guangxi Province-Mengshan county
Ethics committee address [2] 3983 0
Ethics committee country [2] 3983 0
China
Date submitted for ethics approval [2] 3983 0
Approval date [2] 3983 0
29/03/2005
Ethics approval number [2] 3983 0
IRB00001594

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27692 0
Address 27692 0
Country 27692 0
Phone 27692 0
Fax 27692 0
Email 27692 0
Contact person for public queries
Name 11067 0
Jun Zhang
Address 11067 0
National Institute of Diagnostics and Vaccine Development in Infectious Disease (NIDVD)
Xiamen University
Xiamen Fujian 361005
Country 11067 0
China
Phone 11067 0
0086 592 2183111
Fax 11067 0
0086 592 2181258
Email 11067 0
[email protected]
Contact person for scientific queries
Name 1995 0
Jun Zhang
Address 1995 0
National Institute of Diagnostics and Vaccine Development in Infectious Disease (NIDVD)
Xiamen University
Xiamen Fujian 361005
Country 1995 0
China
Phone 1995 0
0086 592 2183111
Fax 1995 0
0086 592 2181258
Email 1995 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.