Dose of Hepatitis B Vaccines in Non/Low-response Populations
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Vaccination; Complications, Reaction, Serum |
Biological: hepatitis B vaccine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Effect of Dose of Hepatitis B Vaccines in Non/Low-response Populations |
- Seroconversion rates of different doses of vaccines the levels of HBs-Ab after vaccination [ Time Frame: day 30 after each vaccination ] [ Designated as safety issue: Yes ]describe the levels of HBs-Ab after each vaccination and compare the percentages of adverse events in all groups
| Estimated Enrollment: | 650 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HepB 5ug
receive the vaccine with 5ug HBsAg
|
Biological: hepatitis B vaccine
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
Other Names:
|
|
Experimental: HepB 10ug
receive the vaccine with 10ug HBsAg
|
Biological: hepatitis B vaccine
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
Other Names:
|
|
Experimental: HepB 20ug
receive the vaccine with 20ug HBsAg
|
Biological: hepatitis B vaccine
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
Other Names:
|
|
Experimental: HepB 60ug
receive the vaccine with 60ug HBsAg
|
Biological: hepatitis B vaccine
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 1 Year to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| China, Beijing | |
| Xicheng Centers For Disease Prevention & Control | Recruiting |
| Xicheng District, Beijing, China, 100011 | |
| Contact: zhen zhang, bachelor 861058360746 | |
| China, Inner Mongolia | |
| Chifeng Centers For Disease Prevention & Control | Recruiting |
| Chifeng, Inner Mongolia, China, 024000 | |
| Contact: xuezeng li, bachelor 864765891156 ma790303@sina.com | |
| Contact: qin si, bachelor 864765896616 | |
| Principal Investigator: | jiang wu, Bachelor | Beijing Centers for Disease Control and Prevention |
More Information
No publications provided
| Responsible Party: | Wu Jiang, Department of Immunization & Prevention, Centers for Disease Control and Prevention, China |
| ClinicalTrials.gov Identifier: | NCT01564134 History of Changes |
| Other Study ID Numbers: | BJCDCWJ201102 |
| Study First Received: | March 23, 2012 |
| Last Updated: | March 26, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Centers for Disease Control and Prevention, China:
|
response vaccination |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on June 18, 2013