Vaccine ReactionNCT06515938
Study on New Strategies for Hepatitis B Virus Immunization
A study testing 20μg Engerix-B hepatitis B vaccine, 20μg Kangtai hepatitis B vaccine and 60μg Kangtai hepatitis B vaccine in people with Vaccine Reaction, run by Wu Jiang at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Reaction
- What is being tested?
- 20μg Engerix-B hepatitis B vaccine, 20μg Kangtai hepatitis B vaccine and 60μg Kangtai hepatitis B vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,169 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2013to 31 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 25-55 years
- negative for HBsAg,anti-HBs, and anti-HBc without prior HBV or HAV vaccination
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
China2 sites
Huaibei District Center for Disease Control and Prevention
Huaibei, Anhui, 235000
Xuanhua District Center for Disease Control and Prevention
Xuanhua, Hebei, 075199
About this study
Official title: Comparative Immunogenicity of Hepatitis B Vaccine With Different Immunization Schedule in Primary Immune Adults Aged 25-55 in China
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.
Read the detailed 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.
- Conditions
- Vaccine Reaction
- Being tested
- 20μg Engerix-B hepatitis B vaccine, 20μg Kangtai hepatitis B vaccine, 60μg Kangtai hepatitis B vaccine, 20μg CHO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20μg Engerix-B hepatitis B vaccineBiological
20μg Kangtai hepatitis B vaccineBiological
60μg Kangtai hepatitis B vaccineBiological
20μg CHOBiological
| Study group | Role | What they receive |
|---|---|---|
| 20μg Engerix-B with 0-1-6 intervals | Experimental | Received three intramuscular injections of the 20μg Engerix-B vaccine with 0, 1, 6 month intervals Receives: Biological: 20μg Engerix-B hepatitis B vaccine |
| 20μg Kangtai with 0-1-6 intervals | Experimental | Received three intramuscular injections of the 20μg Kangtai hepatitis B vaccine with 0, 1, 6 month intervals Receives: Biological: 20μg Kangtai hepatitis B vaccine |
| 60μg Kangtai with 0-2 intervals | Experimental | Received two intramuscular injections of the 60μg Kangtai hepatitis B vaccine with 0, 2 month intervals Receives: Biological: 60μg Kangtai hepatitis B vaccine |
| 20μg CHO with 0-1-6 intervals | Placebo comparator | 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 Receives: Biological: 20μg CHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HBs
Titers of hepatitis B virus surface antibody
Measured: at the second month after the final injection of each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Jan 2013
- Primary completion30 Jun 2014
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wu Jiang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Wu Jiang, Centers for Disease Control and Prevention, China
- Investigators
- Wei Zhang, Principal investigator, Beijing Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515938
- Sponsor's protocol ID
- 2012ZX10002001
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Individual data sharing
- Yes: The original primary outcome data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Immunogenicity of Hepatitis B Vaccine With Different Immunization Schedule in Primary Immune Adults Aged 25-55 in China
- ClinicalTrials.gov ID
- NCT06515938
- Acronym / sponsor ID
- 2012ZX10002001
- Conditions
- Vaccine Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,169 participants (actual)
- Lead sponsor
- Wu JiangOther government
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 20μg Engerix-B with 0-1-6 intervals | Experimental | Biological: 20μg Engerix-B hepatitis B vaccineReceived three intramuscular injections of the 20μg Engerix-B vaccine with 0, 1, 6 month intervals |
| 20μg Kangtai with 0-1-6 intervals | Experimental | Biological: 20μg Kangtai hepatitis B vaccineReceived three intramuscular injections of the 20μg Kangtai hepatitis B vaccine with 0, 1, 6 month intervals |
| 60μg Kangtai with 0-2 intervals | Experimental | Biological: 60μg Kangtai hepatitis B vaccineReceived two intramuscular injections of the 60μg Kangtai hepatitis B vaccine with 0, 2 month intervals |
| 20μg CHO with 0-1-6 intervals | Placebo comparator | Biological: 20μg CHOReceived three intramuscular injections of the 20μg Huabei hepatitis B vaccine made by recombinant DNA techniques in CHO cell with 0, 1, 6 month intervals |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- aged 25-55 years
- negative for HBsAg,anti-HBs, and anti-HBc without prior HBV or HAV vaccination
Key exclusion criteria (6 listed)
- a history of vaccine component allergies
- autoimmune diseases
- immunodeficiency
- vaccinations received within the past month
- acute illnesses within the past week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20μg Engerix-B hepatitis B vaccine | Biological | 20μg Engerix-B with 0-1-6 intervals |
| 20μg Kangtai hepatitis B vaccine | Biological | 20μg Kangtai with 0-1-6 intervals |
| 60μg Kangtai hepatitis B vaccine | Biological | 60μg Kangtai with 0-2 intervals |
| 20μg CHO | Biological | 20μg CHO with 0-1-6 intervals |
Primary outcome
Anti-HBs
Time frame: at the second month after the final injection of each arm
Titers of hepatitis B virus surface antibody
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: Yes. The original primary outcome data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Zhang principal investigator
Beijing Center for Disease Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20μg Engerix-B hepatitis B vaccine, 20μg Kangtai hepatitis B vaccine and 60μg Kangtai hepatitis B vaccine in people with Vaccine Reaction, run by Wu Jiang at 2 sites in China.
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 2 inclusion and 6 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 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anti-HBs (time frame: at the second month after the final injection of each arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2024; AzTrials last refreshed its copy on 2 Nov 2026.