Clinical trial NCT01564134: 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
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination; Complications, Reaction, Serum
Keywords: response vaccination
Lead sponsor: Centers for Disease Control and Prevention, China
Sponsor class: OTHER_GOV
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2012-03-27
Enrollment: 537
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Seroconversion rates of different doses of vaccines the levels of HBs-Ab after vaccination
timeFrame: day 30 after each vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Xicheng District
country: China
facility: Xicheng Centers For Disease Prevention & Control
state: Beijing
city: Chifeng
country: China
facility: Chifeng Centers For Disease Prevention & Control
state: Inner Mongolia
Study officials:
affiliation: Beijing Centers for Disease Control and Prevention
name: jiang wu, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: