The Immunogenicity and Safety of 60mcg/30mcg Recombinant Hepatitis B Vaccines in People Who Failed to Respond to Routine Administration of Hepatitis B Vaccines

April 21, 2012 updated by: Jiangsu Province Centers for Disease Control and Prevention

The Immunogenicity and Safety of 60mcg and 30mcg Recombinant Hepatitis B Vaccines in People Aged 16 and Older Who Failed to Respond to Routine Administration of 10mcg Recombinant Hepatitis B Vaccines

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

1091

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria :

Filter period: The subjects to receive first 10mcg recombinant hepatitis B vaccines:

  • Healthy subjects aged 16 and older as established by medical history and clinical examination
  • The subjects or their guardians are able to understand and sign the informed consent
  • Had never received the hepatitis B vaccines
  • Subjects who can and will comply with the requirements of the protocol

Revaccination period: The nonresponders to receive first 60mcg recombinant hepatitis B vaccines:

  • Healthy subjects aged 16 and older as established by medical history and clinical examination
  • The subjects or their guardians are able to understand and sign the informed consent
  • After the routine administration of 10mcg hepatitis B vaccines, the peak period levels of anti-HBs is lower than 10mIU/ml
  • Subjects with temperature <37.1°C on axillary setting
  • Subjects who can and will comply with the requirements of the protocol

Exclusion Criteria:

Filter period: The subjects to receive first 10mcg recombinant hepatitis B vaccines:

  • Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
  • Family history of seizures or progressive neurological disease
  • Family history of congenital or hereditary immunodeficiency
  • Women of pregnancy, lactation or about to be pregnant in 60 days
  • Autoimmune disease or immunodeficiency
  • Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
  • Any prior administration of administration of immunoglobulins

Filter period: The subjects to receive second or/and third 10mcg recombinant hepatitis B vaccines:

  • Any reaction or hypersensitivity to the recombinant hepatitis B vaccines after the vaccinations
  • Serious adverse reactions to vaccines
  • Active infections
  • Subjects who want to quit the study
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Revaccination period: The nonresponders to receive first 60mcg recombinant hepatitis B vaccines:

  • Qualitative test of Anti-HBs, HBsAg or Anti-HBc on serum is positive
  • Any reaction or hypersensitivity to the recombinant hepatitis B vaccines after the vaccinations
  • Family history of seizures or progressive neurological disease
  • Family history of congenital or hereditary immunodeficiency
  • Women of pregnancy, lactation or about to be pregnant in 60 days
  • Autoimmune disease or immunodeficiency
  • Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
  • Any prior administration of immunoglobulins, any other vaccines or experimental drugs in the last 7days
  • Any active infections and received any antibiotic or anti-virus treatments in the last 7 days
  • Had a fever in the last 3 days, with temperature ≥37.1°C
  • Participate in another clinical trials
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Revaccination period: The nonresponders to receive second or/and third 60mcg recombinant hepatitis B vaccines:

  • Any reaction or hypersensitivity to the recombinant hepatitis B vaccines after the vaccinations
  • Serious adverse reactions to vaccines
  • Active infections
  • Subjects who want to quit the study
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 60mcg/1.0ml recombinant hepatitis B vaccine
600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
Biological: 60mcg/1.0ml recombinant hepatitis B vaccine
to receive 60mcg/1.0ml recombinant HBV vaccines on day 0, 30 and 60
EXPERIMENTAL: 30mcg/1.0ml recombinant hepatitis B vaccine
600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
Biological: 30mcg/1.0ml recombinant hepatitis B vaccine
to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
PLACEBO_COMPARATOR: 10mcg/1.0ml recombinant hepatitis B vaccine
300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
Biological: 10mcg/1.0ml recombinant hepatitis B vaccine
to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders
Time Frame: one month after the second vaccination
Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after second vaccination
one month after the second vaccination
Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders
Time Frame: one month after the third vaccination
Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after third vaccination
one month after the third vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders
Time Frame: one month after the first vaccination
Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after first vaccination
one month after the first vaccination
the Safety of Recombinant Hepatitis B Vaccines in Nonresponders
Time Frame: within the first 30 days after first vaccination
assessment of the local and systemic adverse reaction within the first 30 days after first vaccination
within the first 30 days after first vaccination
the Safety of Recombinant Hepatitis B Vaccines in Nonresponders
Time Frame: within the first 30 days after second vaccination
assessment of the local and systemic adverse reaction within the first 30 days after second vaccination
within the first 30 days after second vaccination
the Safety of Recombinant Hepatitis B Vaccines in Nonresponders
Time Frame: within the first 30 days after third vaccination
assessment of the local and systemic adverse reaction within the first 30 days after third vaccination
within the first 30 days after third vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Collaborators

Shenzhen Kangtai Biological Products Co., LTD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (ESTIMATE)

September 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 27, 2012

Last Update Submitted That Met QC Criteria

April 21, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KT0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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