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OpenTrials
Completed

NCT Number: NCT06515938

Study on New Strategies for Hepatitis B Virus Immunization

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.

Completed

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Key information

Conditions

Vaccine Reaction

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huaibei District Center for Disease Control and Prevention, Huaibei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

20μg Engerix-B hepatitis B vaccine

Biological

20μg Kangtai hepatitis B vaccine

Biological

60μg Kangtai hepatitis B vaccine

Biological

20μg CHO

Biological

Primary outcomes

  1. Anti-HBs

    Time frame: at the second month after the final injection of each arm

    Titers of hepatitis B virus surface antibody

Sponsors and collaborators

Lead sponsor

Wu Jiang

Other Gov

Registry information

Official study title

Comparative Immunogenicity of Hepatitis B Vaccine With Different Immunization Schedule in Primary Immune Adults Aged 25-55 in China

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jul 23, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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