Hepatitis B
Conditions
Keywords
youth, hepatitis B, vaccination, booster, immunity response
Brief summary
At the time of the present study, the necessity for booster vaccinations for the prevention of hepatitis B(HB) 15 years post-vaccination in the group of young adults who have become seronegative for HB markers after complete neonatal HB vaccination was in question. A booster vaccination strategy may lead to a significant economic impact on national health care resources, and the costs/benefits must therefore be carefully evaluated. Unfortunately, the data to support such analyses are lacking. Because an increased risk of HB infection is anticipated when adolescents enter into young adulthood through becoming sexual active, breakthrough infections such as fulminant HB might be the main concern instead of the risk of chronic HB carriage. To address this issue, this study aimed to measure the booster responses after HB vaccination in seronegative young adults who had completed neonatal HB vaccines in Taiwan before.
Detailed description
This cohort study was conducted between October 2007 and Jan 2009. The target population was subjects aged 18-23 years who were born after 1984 when the Taiwanese national HB vaccination program was launched. Their vaccination records must have shown a completed neonatal HB vaccination, and they were seronegative for all three HB viral markers including HBsAg(Hepatitis B surface antigen), anti-HBc(core antibody against Hepatitis B), and anti-HBs(Surface antibody against Hepatitis B) within 2 years of entry into the study and at study entry. They were recruited through a Student's Health Center Clinic referral, Bulletin Board System posts, and Web-broadcast invitation. The neonatal HB vaccination records were verified through linkage to the Taiwan Center for Disease Control databank. Signed informed consent was obtained from all the participants and their parents or guardians. Pregnant females, persons with a previous history of allergy to HB vaccines, or allergy to yeast were excluded. First 3 months are screen phase to recruit college students for assay of hepatitis B viral markers. Seronegative subjects were approached for enrollment into receiving hepatitis B vaccine booster afterwards. All participants were tested for HB markers at enrollment, even if they had been tested in the previous months, to confirm their status. A questionnaire was completed at enrolment to record sociodemographic factors including age, gender, self reported family history of hepatitis B carriers, self reported blood type, and so on. The participants then received three intramuscular doses of HB vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20 microgram/ml/vial, GlaxoSmithKline, Belgium) at baseline and at the 1st and 6th month follow-up visits. Their anti-HBs status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of HB vaccine. Adverse effects associated with the vaccine were also reported within one week after each Engerix-B injection.
Interventions
BIOLOGICALhepatitis B vaccine
Recombinant HBsAg, 20mcg/ml/vial (GSK) one vial IM at Day 0, Month 1, month 6 during follow-up, respectively.
Sponsors
National Science and Technology Council, Taiwan
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 23 Years
Healthy volunteers
Yes
Inclusion criteria
1. aged 18-23 years 2. the youth born after July 1984 who have received a hepatitis B virus markers checkup within 2 years including HBsAg, core antibody against hepatitis B(anti-HBc), and surface antibody against hepatitis B (anti-HBs) and the results are all negative for these 3 viral markers. 3. Participants should agree to sign inform consent. For younger than 20 years old subjects, one of their parents also help the participate review and sign the inform consent. 4. Participants are willing to receive 3 doses of Hepatitis B vaccines without payment. 5. General condition is in good health judged by the doctor
Exclusion criteria
1. Allergy to Hepatitis B vaccines or yeast 2. pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL) | 7 months | The anti-HBs(Surface antibody against Hepatitis B) status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of hepatitis B vaccine. And then the seroprotective rate for anti-HBs(numbers of those who had anti-HBs titer higher than 10 mIU/mL/all participants numbers) was calculated respectively. |
Countries
Taiwan
Participant flow
Recruitment details
This cohort study was conducted between October 2007 and Jan 2009. The participants were recruited through a Student's Health Center Clinic referral, Bulletin Board System posts, and Web-broadcast invitation. They received intervention and blood exam in the hospital.
Pre-assignment details
Initially, 150 seronegative subjects for the three hepatitis B viral markers (HBsAg, anti-HBs, and anti-HBc) were invited to participate in the study. Among them, five subjects were excluded because of seropositive results upon recheck or drop-out. History of complete neonatal HB vaccination could not be confirmed in 18 cases.
Participants by arm
| Arm | Count |
|---|---|
| Hepatitis B Booster They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine. | 127 |
| Total | 127 |
Baseline characteristics
| Characteristic | Hepatitis B Booster |
|---|---|
| Age, Customized < 20 years old | 54 participants |
| Age, Customized >= 20 years old | 73 participants |
| Blood type A | 28 participants |
| Blood type AB | 8 participants |
| Blood type B | 31 participants |
| Blood type O | 53 participants |
| Blood type unknown | 7 participants |
| Body Mass Index(BMI) category 18.5<= BMI < 24 | 94 participants |
| Body Mass Index(BMI) category BMI< 18.5 | 21 participants |
| Body Mass Index(BMI) category BMI >= 24 | 12 participants |
| Family history of hepatitis B carrier NO | 71 participants |
| Family history of hepatitis B carrier Unknown | 38 participants |
| Family history of hepatitis B carrier Yes | 18 participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 127 |
| serious Total, serious adverse events | 0 / 127 |
Outcome results
Primary
Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL)
The anti-HBs(Surface antibody against Hepatitis B) status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of hepatitis B vaccine. And then the seroprotective rate for anti-HBs(numbers of those who had anti-HBs titer higher than 10 mIU/mL/all participants numbers) was calculated respectively.
Time frame: 7 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hepatitis B Booster | Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL) | seroprotective rate of HB vaccine at 7-10 days | 26 participants |
| Hepatitis B Booster | Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL) | seroprotective rate of HB vaccine at one month | 96 participants |
| Hepatitis B Booster | Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL) | seroprotective rate of HB vaccine at 6 months | 120 participants |
| Hepatitis B Booster | Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL) | seroprotective rate of HB vaccine at 7 months | 126 participants |
Comparison: Chi-square analysis and Fischer's exact test were used for comparing group proportions between seropositive and seronegative participants. GMT and their 95% confidence intervals were also calculated using the software developed by Kirkman, T.W. (18) An ANOVA test was performed to compare the difference of the three groups at one, six and seven months categorized by the anti-HBs titers at 7-10 days after the booster.p-value: <0.0595% CI: [0.05, 0.15]t-test, 2 sided