Dose of Hepatitis B Vaccines in Non/Low-response Populations
Primary Purpose
Vaccination; Complications, Reaction, Serum
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hepatitis B vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Vaccination; Complications, Reaction, Serum focused on measuring response vaccination
Eligibility Criteria
Inclusion Criteria:
- aged 1-65 years old
- male or non-pregnant female volunteers
- provide written informed consents before joining the trial
- clinically healthy as determined by: medical history inquiring and physical examination
- negative for HBsAg,HBsAb,HBcAb,HBeAg,HBeAb within the past 1 year
Exclusion Criteria:
- No history of hepatitis B vaccine
- receipt of immunoglobulin within the past 1 month
- allergic to any ingredient of vaccine
- history of serious side effects, such as allergies, hives, breathing difficulties, angioedema or abdominal pain
- severe acute and chronic diseases
- autoimmune disease or immune deficiency
- axillary temperature > 37.0 ℃ over the time of vaccination
Sites / Locations
- Xicheng Centers For Disease Prevention & Control
- Chifeng Centers For Disease Prevention & Control
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
HepB 5ug
HepB 10ug
HepB 20ug
HepB 60ug
Arm Description
receive the vaccine with 5ug HBsAg
receive the vaccine with 10ug HBsAg
receive the vaccine with 20ug HBsAg
receive the vaccine with 60ug HBsAg
Outcomes
Primary Outcome Measures
Seroconversion rates of different doses of vaccines the levels of HBs-Ab after vaccination
describe the levels of HBs-Ab after each vaccination and compare the percentages of adverse events in all groups
Secondary Outcome Measures
Full Information
NCT ID
NCT01564134
First Posted
March 23, 2012
Last Updated
July 9, 2013
Sponsor
Wu Jiang
Collaborators
Beijing Municipal Science & Technology Commission
1. Study Identification
Unique Protocol Identification Number
NCT01564134
Brief Title
Dose of Hepatitis B Vaccines in Non/Low-response Populations
Official Title
Effect of Dose of Hepatitis B Vaccines in Non/Low-response Populations
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wu Jiang
Collaborators
Beijing Municipal Science & Technology Commission
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
An interventional study will be performed in subjects aged 1-65 years old to evaluate effects of different doses of hepatitis B vaccines in low or non-response population.
Detailed Description
A randomized clinical study will be conducted to evaluate effects of different doses of hepatitis B vaccines in low or non-response population in China. 650 low or non-response subjects after hepatitis B vaccination will be enrolled under the premise of informed consent. 200 subjects aged 1-17 years will be divided into 3 groups and 450 subjects aged 18-65years will be divided into 4 groups. Group 1/2/3 will receive 3 doses of vaccine on day 0,30 and 180, with 5ug/10ug/20ug HBs-Ag respectively. Group 4 will receive 1 dose of vaccine with 60ug HBs-Ag, low or nonresponse subjects of which will receive the second dose by an interval of at least 28 days. All vaccinations will be done by specific study personnel, who do not take part in the assessment of safety or immunogenicity. Adverse events will be recorded after vaccination and blood samples were collected at day 30 after each vaccination for antibody detection.
The clinical program approved by the ethics committee will be performed by the researchers independently. Inspectors designated by the sponsor will take meticulous on-site audits to ensure the safety specifications during the whole process of research.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccination; Complications, Reaction, Serum
Keywords
response vaccination
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
537 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HepB 5ug
Arm Type
Experimental
Arm Description
receive the vaccine with 5ug HBsAg
Arm Title
HepB 10ug
Arm Type
Experimental
Arm Description
receive the vaccine with 10ug HBsAg
Arm Title
HepB 20ug
Arm Type
Experimental
Arm Description
receive the vaccine with 20ug HBsAg
Arm Title
HepB 60ug
Arm Type
Experimental
Arm Description
receive the vaccine with 60ug HBsAg
Intervention Type
Biological
Intervention Name(s)
hepatitis B vaccine
Other Intervention Name(s)
HepB 10ug: Hansenula Polymorpha Yeast, HepB 60ug: Saccharomyces cerevisiae
Intervention Description
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
Primary Outcome Measure Information:
Title
Seroconversion rates of different doses of vaccines the levels of HBs-Ab after vaccination
Description
describe the levels of HBs-Ab after each vaccination and compare the percentages of adverse events in all groups
Time Frame
day 30 after each vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
aged 1-65 years old
male or non-pregnant female volunteers
provide written informed consents before joining the trial
clinically healthy as determined by: medical history inquiring and physical examination
negative for HBsAg,HBsAb,HBcAb,HBeAg,HBeAb within the past 1 year
Exclusion Criteria:
No history of hepatitis B vaccine
receipt of immunoglobulin within the past 1 month
allergic to any ingredient of vaccine
history of serious side effects, such as allergies, hives, breathing difficulties, angioedema or abdominal pain
severe acute and chronic diseases
autoimmune disease or immune deficiency
axillary temperature > 37.0 ℃ over the time of vaccination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jiang wu, Bachelor
Organizational Affiliation
Beijing Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xicheng Centers For Disease Prevention & Control
City
Xicheng District
State/Province
Beijing
ZIP/Postal Code
100011
Country
China
Facility Name
Chifeng Centers For Disease Prevention & Control
City
Chifeng
State/Province
Inner Mongolia
ZIP/Postal Code
024000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Dose of Hepatitis B Vaccines in Non/Low-response Populations
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