Vaccine ReactionNCT04439435
Evaluation of Immunoprotection Provided by Hepatitis B Vaccine After Birth in Healthy Children
An observational study of Vaccine 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
- Vaccine Reaction
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2020to Oct 2021
- 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: Healthy Children Aged 1-15 in Chongqing
Who may be able to join
- Children who are 1-15 years old in Chongqing
- After birth, three injections of Hep B were inoculated in time according to the procedure of 0, 1 and 6 months(The vaccination certificate record)
- No HBV booster vaccine given since primary HBV immunization
- Children or guardian knew and agreed to accept the study
- Follow - up study and blood collection after vaccination can be accepted
Who cannot join
- Unwilling or impossible to participate in this research project;
- Have a history of allergy or have had a serious vaccine reaction
- Have immune impairment diseases and appear immune impairment;
- Immunosuppressive treatment, receive any injection or oral administration of cortisone or cancer chemotherapy;
- Any kind of vaccine or any kind of observation drug has been vaccinated in the past four weeks;
- Any acute disease or other infection requiring antibiotic or antiviral treatment in the past four weeks;
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- Fever symptoms occurred in the past week ( axillary temperature ≥ 38 °C)
- Blood transfusion experience;
- Has a history of more serious infectious diseases ( five types of hepatitis, AIDS, syphilis, gonorrhea, etc. );
- Hepatitis B infection or carriers(lineal relationship);
- Abnormal physical examination
Trial locations and contacts
1 site in 1 country.
China1 site
Chongqing Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
YAO ZHAO, postdoctor, 86-23-6360-3083, Zhaoy@cqmu.edu.cn
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 evaluate the existence of immune protection in healthy children with negative hepatitis B surface antibody and find a method to evaluate the immune protection induced by hepatitis B vaccine.
Read the detailed description
One method to determine the long-term protection provided by hepatitis B vaccine against HBV infection is to estimate the cumulative incidence of chronic carrier status and breakthrough infection of previously vaccinated individuals in different periods. Up to now, no international standard suggests that hepatitis B vaccine should be used as a routine immunization program. However, it is an important issue to discuss the immune protection of healthy children with negative hepatitis B surface antibody and the duration of this protection in the future. Therefore, this study aims to evaluate the existence of immune protection of healthy children with negative hepatitis B surface antibody, find a method to evaluate the immune protection induced by hepatitis B vaccine.
The main content of the study: To recruit healthy children. Children lacking HBsAb were selected for immune memory test and receive a Hep B booster. The results of Antibody positive group and antibody negative group were compared and analyzed. To find out the most suitable method for evaluating immune protection.
- Conditions
- Vaccine Reaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Cellular Immunity in Children with Negative Hepatitis B Antibody
Measured: 1-month
Changes of humoral and cellular immune response after hepatitis B vaccine boosters
Measured: 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study startJul 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionOct 2021 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 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
- NCT04439435
- Sponsor's protocol ID
- 2020-06
- Status last verified
- Jun 2020
- First submitted
- 17 Jun 2020
- Last updated
- 19 Jun 2020
- 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 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunoprotection Provided by Hepatitis B Vaccine After Birth in Healthy Children
- ClinicalTrials.gov ID
- NCT04439435
- Acronym / sponsor ID
- 2020-06
- Conditions
- Vaccine Reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 19 Jun 2020 (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 evaluate the existence of immune protection in healthy children with negative hepatitis B surface antibody and find a method to evaluate the immune protection induced by hepatitis B vaccine.
Detailed description
One method to determine the long-term protection provided by hepatitis B vaccine against HBV infection is to estimate the cumulative incidence of chronic carrier status and breakthrough infection of previously vaccinated individuals in different periods. Up to now, no international standard suggests that hepatitis B vaccine should be used as a routine immunization program. However, it is an important issue to discuss the immune protection of healthy children with negative hepatitis B surface antibody and the duration of this protection in the future. Therefore, this study aims to evaluate the existence of immune protection of healthy children with negative hepatitis B surface antibody, find a method to evaluate the immune protection induced by hepatitis B vaccine.
The main content of the study: To recruit healthy children. Children lacking HBsAb were selected for immune memory test and receive a Hep B booster. The results of Antibody positive group and antibody negative group were compared and analyzed. To find out the most suitable method for evaluating immune protection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy Children Aged 1-15 in Chongqing
Key inclusion criteria (5 listed)
- Children who are 1-15 years old in Chongqing
- After birth, three injections of Hep B were inoculated in time according to the procedure of 0, 1 and 6 months(The vaccination certificate record)
- No HBV booster vaccine given since primary HBV immunization
- Children or guardian knew and agreed to accept the study
- Follow - up study and blood collection after vaccination can be accepted
Key exclusion criteria (11 listed)
- Unwilling or impossible to participate in this research project;
- Have a history of allergy or have had a serious vaccine reaction
- Have immune impairment diseases and appear immune impairment;
- Immunosuppressive treatment, receive any injection or oral administration of cortisone or cancer chemotherapy;
- Any kind of vaccine or any kind of observation drug has been vaccinated in the past four weeks;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Cellular Immunity in Children with Negative Hepatitis B Antibody
Time frame: 1-month
Changes of humoral and cellular immune response after hepatitis B vaccine boosters
Time frame: 1-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
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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 Vaccine 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?
The sponsor lists 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 19 Jun 2020. 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?
Proportion of Cellular Immunity in Children with Negative Hepatitis B Antibody (time frame: 1-month). 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?
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 19 Jun 2020.