This study is an expanded Phase 2/Phase 3 clinical trial base on the safety data obtained from the phase 1 clinical trial. The purpose of this study is to further evaluate the immunogenicity and safety of 60mcg/30mcg recombinant hepatitis B vaccines in people aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines and to explore the optimizing immunizing dose and immune procedure.
The most effective method to prevent hepatitis B virus infection is to receive the vaccination of hepatitis b vaccine to get the protective antibody anti-HBs. Both the blood-derived hepatitis B vaccine and the recombinant hepatitis B vaccines have been proved to be effective and safe since the application in 1981 and 1989 respectively. Previous passive or active immunization testes indicated that the lowest effective level of anti-HBs for prevention of infection is 10mIU/ml. However there are still some recipients can't generate expected level of anti-HBs after the vaccinations. In adults, there are 5% to 10% recipients will failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines, and those nonresponders are susceptible population even after the vaccinations. In this study, a recipient whose peak period (1 month after vaccination) levels of anti-HBs is lower than 10mIU/ml after finishing the vaccinations of 3 dose 10mcg hepatitis b vaccines is called nonresponders. Nowadays, a lot tests are conducted on nonresponders to help them generate the protective antibody anti-HBs, including increase the antigen dosage of vaccines, increase the injections of vaccines, change the route of inoculation and the use of adjuvant. Unfortunately, these previous studies can not get coincident and persuasive outcomes due to the small sample size and poor representativeness. This study is plan to evaluate the immunogenicity and safety of 60mcg/30mcg recombinant hepatitis B vaccines in people aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines and to provide the scientific evidences for the revaccination strategy in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,091
to receive 60mcg/1.0ml recombinant HBV vaccines on day 0, 30 and 60
to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60
Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders
Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after second vaccination
Time frame: one month after the second vaccination
Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders
Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after third vaccination
Time frame: one month after the third vaccination
Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders
Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after first vaccination
Time frame: one month after the first vaccination
the Safety of Recombinant Hepatitis B Vaccines in Nonresponders
assessment of the local and systemic adverse reaction within the first 30 days after first vaccination
Time frame: within the first 30 days after first vaccination
the Safety of Recombinant Hepatitis B Vaccines in Nonresponders
assessment of the local and systemic adverse reaction within the first 30 days after second vaccination
Time frame: within the first 30 days after second vaccination
the Safety of Recombinant Hepatitis B Vaccines in Nonresponders
assessment of the local and systemic adverse reaction within the first 30 days after third vaccination
Time frame: within the first 30 days after third vaccination
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