Dose of Hepatitis B Vaccines in Non/Low-response Populations

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Dose of Hepatitis B Vaccines in Non/Low-response Populations

Conditions
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Vaccination; Complications, Reaction, Serum

Intervention / Treatment
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* Biological: hepatitis B vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HepB 5ug<br>receive the vaccine with 5ug HBsAg | Biological: hepatitis B vaccine<br>* hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg<br>* Other names: HepB 60ug: Saccharomyces cerevisiae;|
| Experimental: HepB 10ug<br>receive the vaccine with 10ug HBsAg | Biological: hepatitis B vaccine<br>* hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg<br>* Other names: HepB 60ug: Saccharomyces cerevisiae;|
| Experimental: HepB 20ug<br>receive the vaccine with 20ug HBsAg | Biological: hepatitis B vaccine<br>* hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg<br>* Other names: HepB 60ug: Saccharomyces cerevisiae;|
| Experimental: HepB 60ug<br>receive the vaccine with 60ug HBsAg | Biological: hepatitis B vaccine<br>* hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg<br>* Other names: HepB 60ug: Saccharomyces cerevisiae;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | day 30 after each vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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response vaccination