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

Wu Jiang

Status: Completed

Conditions: Vaccination; Complications, Reaction, Serum

Treatments: Biological: hepatitis B vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01564134

BJCDCWJ201102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 537 patients

Sex: All

Ages: 1 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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537 participants in 4 patient groups

HepB 5ug

Experimental group

Description:

receive the vaccine with 5ug HBsAg

Treatment:

Biological: hepatitis B vaccine

HepB 10ug

Experimental group

Description:

receive the vaccine with 10ug HBsAg

Treatment:

Biological: hepatitis B vaccine

HepB 20ug

Experimental group

Description:

receive the vaccine with 20ug HBsAg

Treatment:

Biological: hepatitis B vaccine

HepB 60ug

Experimental group

Description:

receive the vaccine with 60ug HBsAg

Treatment:

Biological: hepatitis B vaccine