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Hepatitis bPhase 2/3NCT01203319

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

A Phase 2/3 study testing 60mcg/1.0ml recombinant hepatitis B vaccine, 30mcg/1.0ml recombinant hepatitis B vaccine and 10mcg/1.0ml recombinant hepatitis B vaccine in people with Hepatitis b, run by Jiangsu Province Centers for Disease Control and Prevention.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Hepatitis b
What is being tested?
60mcg/1.0ml recombinant hepatitis B vaccine, 30mcg/1.0ml recombinant hepatitis B vaccine and 10mcg/1.0ml recombinant hepatitis B vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,091 participants
Where
No sites listed yet
Study dates
Nov 2006to Mar 2011
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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

About this study

Official title: 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.

Read the 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.

Conditions
Hepatitis b
Being tested
60mcg/1.0ml recombinant hepatitis B vaccine, 30mcg/1.0ml recombinant hepatitis B vaccine, 10mcg/1.0ml recombinant hepatitis B vaccine
Keywords
immunogenicity, safety, recombinant hepatitis B vaccine, nonresponders
Medical subject headings
Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 60mcg/1.0ml recombinant hepatitis B vaccineBiological

    to receive 60mcg/1.0ml recombinant HBV vaccines on day 0, 30 and 60

  • 30mcg/1.0ml recombinant hepatitis B vaccineBiological

    to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.

  • 10mcg/1.0ml recombinant hepatitis B vaccineBiological

    to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60

Study groups in NCT01203319
Study groupRoleWhat they receive
60mcg/1.0ml recombinant hepatitis B vaccineExperimental600 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.
Receives: Biological: 60mcg/1.0ml recombinant hepatitis B vaccine
30mcg/1.0ml recombinant hepatitis B vaccineExperimental600 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.
Receives: Biological: 30mcg/1.0ml recombinant hepatitis B vaccine
10mcg/1.0ml recombinant hepatitis B vaccinePlacebo comparator300 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.
Receives: Biological: 10mcg/1.0ml recombinant hepatitis B vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: one month after the second vaccination

  2. 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

    Measured: one month after the third vaccination

Secondary outcomes (4)

  1. 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

    Measured: one month after the first vaccination

  2. 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

    Measured: within the first 30 days after first vaccination

  3. 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

    Measured: within the first 30 days after second vaccination

  4. 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

    Measured: within the first 30 days after third vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2010 (estimated)
  2. Study startNov 2006
  3. Primary completionDec 2010
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,091 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01203319
Sponsor's protocol ID
KT0003
Status last verified
Apr 2012
First submitted
15 Sep 2010
Last updated
27 Apr 2012
Data monitoring committee
Yes

Publications

  • Pan HX, Zeng Y, Song XF, Zhang YJ, Xu K, Liang ZL, Zhu FC. Immune response to hepatitis B vaccine with high antigen content in non-responders after standard primary vaccination in Chinese adults. Vaccine. 2014 Jun 17;32(29):3706-12. doi: 10.1016/j.vaccine.2014.02.094. Epub 2014 Mar 27.

    PubMed 24681228

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing 60mcg/1.0ml recombinant hepatitis B vaccine, 30mcg/1.0ml recombinant hepatitis B vaccine and 10mcg/1.0ml recombinant hepatitis B vaccine in people with Hepatitis b, run by Jiangsu Province Centers for Disease Control and Prevention.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders (time frame: one month after the second vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01203319, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2012.

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