Vaccination; Complications, Reaction, SerumNCT01564134
Dose of Hepatitis B Vaccines in Non/Low-response Populations
A study testing hepatitis B vaccine in people with Vaccination; Complications, Reaction, Serum, run by Wu Jiang at 2 sites in China.
Trial summary
An interventional study will be performed in subjects aged 1-65 years old to evaluate effects of different doses of hepatitis B vaccines in low or non-response population. Read more about this study
- Who is it for?
- Ages 1 year to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccination; Complications, Reaction, Serum
- What is being tested?
- hepatitis B vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 537 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2011to Jun 2012
- 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 1 year to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- aged 1-65 years old
- male or non-pregnant female volunteers
- provide written informed consents before joining the trial
- clinically healthy as determined by: medical history inquiring and physical examination
- negative for HBsAg,HBsAb,HBcAb,HBeAg,HBeAb within the past 1 year
Who cannot join
- No history of hepatitis B vaccine
- receipt of immunoglobulin within the past 1 month
- allergic to any ingredient of vaccine
- history of serious side effects, such as allergies, hives, breathing difficulties, angioedema or abdominal pain
- severe acute and chronic diseases
- autoimmune disease or immune deficiency
- axillary temperature > 37.0 ℃ over the time of vaccination
Trial locations and contacts
2 sites in 1 country.
China2 sites
Chifeng Centers For Disease Prevention & Control
Chifeng, Inner Mongolia, 024000
Xicheng Centers For Disease Prevention & Control
Xicheng District, Beijing Municipality, 100011
About this study
Official title: Effect of Dose of Hepatitis B Vaccines in Non/Low-response Populations
An interventional study will be performed in subjects aged 1-65 years old to evaluate effects of different doses of hepatitis B vaccines in low or non-response population.
Read the detailed description
A randomized clinical study will be conducted to evaluate effects of different doses of hepatitis B vaccines in low or non-response population in China. 650 low or non-response subjects after hepatitis B vaccination will be enrolled under the premise of informed consent. 200 subjects aged 1-17 years will be divided into 3 groups and 450 subjects aged 18-65years will be divided into 4 groups. Group 1/2/3 will receive 3 doses of vaccine on day 0,30 and 180, with 5ug/10ug/20ug HBs-Ag respectively. Group 4 will receive 1 dose of vaccine with 60ug HBs-Ag, low or nonresponse subjects of which will receive the second dose by an interval of at least 28 days. All vaccinations will be done by specific study personnel, who do not take part in the assessment of safety or immunogenicity. Adverse events will be recorded after vaccination and blood samples were collected at day 30 after each vaccination for antibody detection.
The clinical program approved by the ethics committee will be performed by the researchers independently. Inspectors designated by the sponsor will take meticulous on-site audits to ensure the safety specifications during the whole process of research.
- Being tested
- hepatitis B vaccine
- Keywords
- response vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatitis B vaccineBiological
Also called HepB 10ug: Hansenula Polymorpha Yeast, HepB 60ug: Saccharomyces cerevisiae
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
| Study group | Role | What they receive |
|---|---|---|
| HepB 5ug | Experimental | receive the vaccine with 5ug HBsAg Receives: Biological: hepatitis B vaccine |
| HepB 10ug | Experimental | receive the vaccine with 10ug HBsAg Receives: Biological: hepatitis B vaccine |
| HepB 20ug | Experimental | receive the vaccine with 20ug HBsAg Receives: Biological: hepatitis B vaccine |
| HepB 60ug | Experimental | receive the vaccine with 60ug HBsAg Receives: Biological: hepatitis B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rates of different doses of vaccines the levels of HBs-Ab after vaccination
describe the levels of HBs-Ab after each vaccination and compare the percentages of adverse events in all groups
Measured: day 30 after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startAug 2011
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination; Complications, Reaction, SerumStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 537 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wu Jiang
- Sponsor type
- Other government
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Sponsor-investigator, Wu Jiang, Centers for Disease Control and Prevention, China
- Investigators
- jiang wu, Bachelor, Principal investigator, Beijing Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564134
- Sponsor's protocol ID
- BJCDCWJ201102
- Status last verified
- Jul 2013
- First submitted
- 23 Mar 2012
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dose of Hepatitis B Vaccines in Non/Low-response Populations
- ClinicalTrials.gov ID
- NCT01564134
- Acronym / sponsor ID
- BJCDCWJ201102
- Keywords
- response vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- Wu JiangOther government
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- Aug 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Mar 2012 (estimated)
- 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.
An interventional study will be performed in subjects aged 1-65 years old to evaluate effects of different doses of hepatitis B vaccines in low or non-response population.
Detailed description
A randomized clinical study will be conducted to evaluate effects of different doses of hepatitis B vaccines in low or non-response population in China. 650 low or non-response subjects after hepatitis B vaccination will be enrolled under the premise of informed consent. 200 subjects aged 1-17 years will be divided into 3 groups and 450 subjects aged 18-65years will be divided into 4 groups. Group 1/2/3 will receive 3 doses of vaccine on day 0,30 and 180, with 5ug/10ug/20ug HBs-Ag respectively. Group 4 will receive 1 dose of vaccine with 60ug HBs-Ag, low or nonresponse subjects of which will receive the second dose by an interval of at least 28 days. All vaccinations will be done by specific study personnel, who do not take part in the assessment of safety or immunogenicity. Adverse events will be recorded after vaccination and blood samples were collected at day 30 after each vaccination for antibody detection.
The clinical program approved by the ethics committee will be performed by the researchers independently. Inspectors designated by the sponsor will take meticulous on-site audits to ensure the safety specifications during the whole process of research.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HepB 5ug | Experimental | Biological: hepatitis B vaccinereceive the vaccine with 5ug HBsAg |
| HepB 10ug | Experimental | Biological: hepatitis B vaccinereceive the vaccine with 10ug HBsAg |
| HepB 20ug | Experimental | Biological: hepatitis B vaccinereceive the vaccine with 20ug HBsAg |
| HepB 60ug | Experimental | Biological: hepatitis B vaccinereceive the vaccine with 60ug HBsAg |
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- aged 1-65 years old
- male or non-pregnant female volunteers
- provide written informed consents before joining the trial
- clinically healthy as determined by: medical history inquiring and physical examination
- negative for HBsAg,HBsAb,HBcAb,HBeAg,HBeAb within the past 1 year
Key exclusion criteria (7 listed)
- No history of hepatitis B vaccine
- receipt of immunoglobulin within the past 1 month
- allergic to any ingredient of vaccine
- history of serious side effects, such as allergies, hives, breathing difficulties, angioedema or abdominal pain
- severe acute and chronic diseases
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 |
|---|---|---|
| hepatitis B vaccineAlso: HepB 10ug: Hansenula Polymorpha Yeast, HepB 60ug: Saccharomyces cerevisiaehepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg | Biological | HepB 10ug, HepB 20ug, HepB 5ug, HepB 60ug |
Primary outcome
Seroconversion rates of different doses of vaccines the levels of HBs-Ab after vaccination
Time frame: day 30 after each vaccination
describe the levels of HBs-Ab after each vaccination and compare the percentages of adverse events in all groups
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 10 Jul 2013.
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.
jiang wu, Bachelor principal investigator
Beijing Centers 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 hepatitis B vaccine in people with Vaccination; Complications, Reaction, Serum, 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 5 inclusion and 7 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 10 Jul 2013. 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. 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?
Seroconversion rates of different doses of vaccines the levels of HBs-Ab after vaccination (time frame: day 30 after each vaccination). 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 10 Jul 2013.