Study on New Strategies for Hepatitis B Virus Immunization

Wu Jiang

Status: Completed

Conditions: Vaccine Reaction

Treatments: Biological: 20μg CHO; Biological: 20μg Kangtai hepatitis B vaccine; Biological: 20μg Engerix-B hepatitis B vaccine; Biological: 60μg Kangtai hepatitis B vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT06515938

2012ZX10002001

Details and patient eligibility

About

To investigate the immunogenicity of HB vaccine with different series among primary immune adults aged 25-55, to assess potential alternative approaches for HB immunization.

Full description

By comparing the immunization effect of hepatitis B vaccine with other different types of hepatitis B vaccines using seris procedure, information on the immunization effect of 60 micrograms of hepatitis B vaccine in adults was obtained, which will provide a scientific basis for the development of a rapid immunization procedure for adults with large doses of hepatitis B vaccine and for the improvement of the immunization strategy for hepatitis B in adults.

Enrollment: 1,169 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• aged 25-55 years
• negative for HBsAg,anti-HBs, and anti-HBc without prior HBV or HAV vaccination

Exclusion criteria

• a history of vaccine component allergies
• autoimmune diseases
• immunodeficiency
• vaccinations received within the past month
• acute illnesses within the past week
• fever (axillary temperature exceeding 38°C) within the past three days

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,169 participants in 4 patient groups, including a placebo group

20μg Engerix-B with 0-1-6 intervals

Experimental group

Description:

Received three intramuscular injections of the 20μg Engerix-B vaccine with 0, 1, 6 month intervals

Treatment:

Biological: 20μg Engerix-B hepatitis B vaccine

20μg Kangtai with 0-1-6 intervals

Experimental group

Description:

Received three intramuscular injections of the 20μg Kangtai hepatitis B vaccine with 0, 1, 6 month intervals

Treatment:

Biological: 20μg Kangtai hepatitis B vaccine

60μg Kangtai with 0-2 intervals

Experimental group

Description:

Received two intramuscular injections of the 60μg Kangtai hepatitis B vaccine with 0, 2 month intervals

Treatment:

Biological: 60μg Kangtai hepatitis B vaccine

20μg CHO with 0-1-6 intervals

Placebo Comparator group

Description:

Received three intramuscular injections of the 20μg Huabei hepatitis B vaccine made by recombinant DNA techniques in CHO cell with 0, 1, 6 month intervals

Treatment:

Biological: 20μg CHO