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

Vaccination; Complications, Reaction, Serum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564134
• Other study ID #: BJCDCWJ201102
• Status: Completed
• Phase: N/A
• First received: March 23, 2012
• Last updated: July 9, 2013
• Start date: August 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2013
• Source: Centers for Disease Control and Prevention, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 537
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis B
• Vaccination; Complications, Reaction, Serum

Intervention

Biological:
• hepatitis B vaccine
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg

Locations

Country	Name	City	State
China	Chifeng Centers For Disease Prevention & Control	Chifeng	Inner Mongolia
China	Xicheng Centers For Disease Prevention & Control	Xicheng District	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Wu Jiang	Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes