Vaccination; Complications, Reaction, Serum
Conditions
Keywords
response vaccination
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.
Interventions
BIOLOGICALhepatitis B vaccine
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
Sponsors
Beijing Municipal Science & Technology Commission
Wu Jiang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rates of different doses of vaccines the levels of HBs-Ab after vaccination | day 30 after each vaccination | describe the levels of HBs-Ab after each vaccination and compare the percentages of adverse events in all groups |
Countries
China
Outcome results
None listed