Hepatitis B Vaccine Adverse ReactionNCT03867643
Efficacy of Hepatitis B Vaccine Boosters Among Neonatally Vaccinated Children in Chongqing
An observational study of Hepatitis B Vaccine Adverse Reaction, run by Children's Hospital of Chongqing Medical University at 1 site in China.
Trial summary
Worldwide, hepatitis B virus (HBV) infection is a major cause of acute hepatitis, and chronic infection with HBV often leads to chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma. So far, the most effective way to prevent HBV infection in susceptible population is to inject hepatitis B vaccine. Read more about this study
- Who is it for?
- Ages 1 year to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B Vaccine Adverse Reaction
- What is being tested?
- hepatitis B vaccine(HepB)
- Type of treatment
- Vaccines
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2021to 31 Dec 2025
- Phase
- Observational
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 1. History of allergy or adverse reaction of vaccine; 2. History of immunosuppressive treatment or immunodeficiency; 3. Any kind of vaccination in the past four weeks; 4. Any acute disease or anti-infective therapy in the past four weeks; 5. Fever history in the past one week (axillary temperature ≥ 38 ℃); 6. Blood transfusion history; 7. History of infectious diseases (hepatitis, AIDS, syphilis, gonorrhea, etc.); 8. The family history of HBV in three generations of lineal relatives; 9. Abnormal physical examination.
- Born after Jan. 1st, 2005 in Chongqing, China;
- Completion of the full primary immunization of HepB after birth;
- No HBV booster vaccine history.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
Yao Zhao, postdoctor
About this study
Worldwide, hepatitis B virus (HBV) infection is a major cause of acute hepatitis, and chronic infection with HBV often leads to chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma. So far, the most effective way to prevent HBV infection in susceptible population is to inject hepatitis B vaccine. However, long-term protection against hepatitis B virus (HBV) after vaccination remains widely debated. This study aims to carry out a comprehensive study to evaluate the efficacy of hepatitis B vaccine booster from the aspect of humoral and cellular immunity in neonatally vaccinated children in Chongqing.
Read the detailed description
Hepatitis B virus (HBV) infection is a major public health problem around the world. More than 2 billion people have been infected with HBV. Although the World Health Organization (WHO) has incorporated hepatitis B vaccination into routine immunization programs for infants and adolescents since 1986 to reduce the incidence of chronic liver diseases, liver cirrhosis and hepatocellular carcinoma associated with hepatitis B virus, there are still more than 400 million chronic carriers. Although it is currently recognized that the most effective way to prevent HBV infection in susceptible population is to inject hepatitis B vaccine, the protective effect of the neonatally vaccinated children weakened as time goes on, which involves the question of the need of boosters. However, there are still some problems concerning hepatitis B vaccine boosters for healthy children. In China, there has not been a standardized directory to guide hepatitis B vaccine booster. Scholars have great controversy on the necessity, age, dosage and other aspects of hepatitis B vaccine booster. Researchers conducted an investigation on the Anti-HBs level of 93,326 Chinese children aged 1 - 16 who completed basic immunization. The results showed that the proportion of HBsAb positive in children aged 1 - 8 years old decreased dramatically, with 8 - year - old children having the lowest proportion of protective antibody. Therefore, this study is intended to explore the protective effect of hepatitis B vaccine on the body and the effect of multiple vaccines. This study will recruit some healthy children with anti-HBs at a low level (titer <10mIU/mL and [10,100) mIU/mL) in Chongqing and conduct selective re-vaccination according to the results of the first detection of hepatitis B surface markers in healthy children. According to the changes of immune status after booster, the efficacy of hepatitis B vaccine boosters was comprehensively evaluated.
- Conditions
- Hepatitis B Vaccine Adverse Reaction
- Being tested
- hepatitis B vaccine(HepB)
- Keywords
- Hepatitis B Vaccine, booster, Immune response
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatitis B vaccine(HepB)Biological
Children with anti-HBs at a low level (<10mIU/mL and [10,100) mIU/mL) were received a dose of hepatitis B vaccine booster after informed consent.
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis B vaccine booster | Children with anti-HBs at a level of<10mIU/mL or [10,100) mIU/mL before booster. Receives: Biological: hepatitis B vaccine(HepB) | |
| Observation | Children with anti-HBs at a level of >100mIU/mL or [10,100) mIU/mL before booster. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAb positive rate
The proportion of HBsAb in children with and without hepatitis B vaccine boosters
Measured: 3-year
HBsAg-specific T cell response
The proportion of HBsAg-specific IFN-γ-producing T cells in children with and without hepatitis B vaccine boosters
Measured: 3-year
HBsAb protective efficacy
Evaluate the changes in the protective efficacy of HBsAb after hepatitis B vaccine booster
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start9 Jul 2021
- Primary completion9 Sep 2021
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B Vaccine Adverse 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiu Li, Children's Hospital of Chongqing Medical University
- Investigators
- Yao Zhao, postdoctor, Study director, Chongqing Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867643
- Sponsor's protocol ID
- 2019-09
- Status last verified
- Mar 2022
- First submitted
- 5 Mar 2019
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hepatitis B Vaccine Boosters Among Neonatally Vaccinated Children in Chongqing
- ClinicalTrials.gov ID
- NCT03867643
- Acronym / sponsor ID
- 2019-09
- Conditions
- Hepatitis B Vaccine Adverse Reaction
- Keywords
- Hepatitis B Vaccine, booster, Immune response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Mar 2019 (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.
Worldwide, hepatitis B virus (HBV) infection is a major cause of acute hepatitis, and chronic infection with HBV often leads to chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma. So far, the most effective way to prevent HBV infection in susceptible population is to inject hepatitis B vaccine. However, long-term protection against hepatitis B virus (HBV) after vaccination remains widely debated. This study aims to carry out a comprehensive study to evaluate the efficacy of hepatitis B vaccine booster from the aspect of humoral and cellular immunity in neonatally vaccinated children in Chongqing.
Detailed description
Hepatitis B virus (HBV) infection is a major public health problem around the world. More than 2 billion people have been infected with HBV. Although the World Health Organization (WHO) has incorporated hepatitis B vaccination into routine immunization programs for infants and adolescents since 1986 to reduce the incidence of chronic liver diseases, liver cirrhosis and hepatocellular carcinoma associated with hepatitis B virus, there are still more than 400 million chronic carriers. Although it is currently recognized that the most effective way to prevent HBV infection in susceptible population is to inject hepatitis B vaccine, the protective effect of the neonatally vaccinated children weakened as time goes on, which involves the question of the need of boosters. However, there are still some problems concerning hepatitis B vaccine boosters for healthy children. In China, there has not been a standardized directory to guide hepatitis B vaccine booster. Scholars have great controversy on the necessity, age, dosage and other aspects of hepatitis B vaccine booster. Researchers conducted an investigation on the Anti-HBs level of 93,326 Chinese children aged 1 - 16 who completed basic immunization. The results showed that the proportion of HBsAb positive in children aged 1 - 8 years old decreased dramatically, with 8 - year - old children having the lowest proportion of protective antibody. Therefore, this study is intended to explore the protective effect of hepatitis B vaccine on the body and the effect of multiple vaccines. This study will recruit some healthy children with anti-HBs at a low level (titer <10mIU/mL and [10,100) mIU/mL) in Chongqing and conduct selective re-vaccination according to the results of the first detection of hepatitis B surface markers in healthy children. According to the changes of immune status after booster, the efficacy of hepatitis B vaccine boosters was comprehensively evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatitis B vaccine booster | – | Biological: hepatitis B vaccine(HepB)Children with anti-HBs at a level of<10mIU/mL or [10,100) mIU/mL before booster. |
| Observation | – | –Children with anti-HBs at a level of >100mIU/mL or [10,100) mIU/mL before booster. |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 1. History of allergy or adverse reaction of vaccine; 2. History of immunosuppressive treatment or immunodeficiency; 3. Any kind of vaccination in the past four weeks; 4. Any acute disease or anti-infective therapy in the past four weeks; 5. Fever history in the past one week (axillary temperature ≥ 38 ℃); 6. Blood transfusion history; 7. History of infectious diseases (hepatitis, AIDS, syphilis, gonorrhea, etc.); 8. The family history of HBV in three generations of lineal relatives; 9. Abnormal physical examination.
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 vaccine(HepB)Children with anti-HBs at a low level (<10mIU/mL and [10,100) mIU/mL) were received a dose of hepatitis B vaccine booster after informed consent. | Biological | Hepatitis B vaccine booster |
Primary outcome
HBsAb positive rate
Time frame: 3-year
The proportion of HBsAb in children with and without hepatitis B vaccine boosters
HBsAg-specific T cell response
Time frame: 3-year
The proportion of HBsAg-specific IFN-γ-producing T cells in children with and without hepatitis B vaccine boosters
HBsAb protective efficacy
Time frame: 3-year
Evaluate the changes in the protective efficacy of HBsAb after hepatitis B vaccine booster
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
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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.
Yao Zhao, postdoctor study director
Chongqing Children's Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B Vaccine Adverse Reaction, run by Children's Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yao Zhao, postdoctor (86-23-6360-3083, Zhaoy@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBsAb positive rate (time frame: 3-year). The study lists 3 primary outcomes in all. 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 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.