Hepatitis B Vaccination
Conditions
Keywords
Hepatitis B vaccination, Immunogenicity, Randomized controlled trial, Drug abuse
Brief summary
Uptake, adherence, and completion of vaccination among drug users were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect drug users from HBV infection. This is a randomized, open-label, blank-controlled trial, conducted among drug users with drug rehabilitation. This study will compare the immunogenicity and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug users
Detailed description
Comparison of 2 vaccination strategy against Hepatitis B in Drug Users Intervention: Arm 1 : Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6; Arm 2 : Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6; Arm 3 : Receive no vaccination during the study period.
Interventions
BIOLOGICAL60 µg dose hepatitis B vaccine
three-dose, 60 µg per dose
BIOLOGICAL20 µg dose hepatitis B vaccine
three-dose, 20 µg per dose
Sponsors
Centers for Disease Control and Prevention, China
Shanxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18 and 70 years at the enrolment * current illicit drug users before drug rehabilitation * negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment * having spent acute physiological detoxification phase
Exclusion criteria
* any intolerance or allergy to any component of the vaccine * ongoing opportunistic infection * liver disease * hemopathy * cancer * unexplained fever in the last week before the recruiting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 | Month 7 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）. The accepted protective serum anti-HBs level was ≥10 mIU/ml. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-HBs Concentration at Month 7 | Month 7 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）. |
| Anti-HBs Concentration at Month 12 | Month 12 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）. |
| Number and Rate of Participants With Anti-HBs Seroconversion at Month 12 | Month 12 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）. The accepted protective serum anti-HBs level was ≥10 mIU/ml. |
| Occurrence of Adverse Events After Vaccination | Within 7 days after the vaccination, at Month 0, 1, and 6 | Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B |
| Serious Adverse Events (SAE) Occurred During Month 12 | Month 0-12 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number and Rate of Participants With Anti-HBs High-level Response at Month 12 | Month 12 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response. |
| Anti-HBs Concentration at Month 6 Before the Third Injection | Month 6 before the third injection | Anti-HBs concentration at month 6 before the third injection by CMIA |
| Number and Rate of Participants With Anti-HBs Seroconversion at Month 6 Before the Third Injection | Month 6 before the third injection | The measurements of anti-HBs antibodies were determined quantitatively by CMIA. The accepted protective serum anti-HBs level was ≥10 mIU/ml. |
| Number and Rate of Participants With Anti-HBs High-level Response at Month 6 Before the Third Injection | Month 6 before the third injection | The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response. |
| Number and Rate of Participants With Anti-HBs High-level Response at Month 7 | Month 7 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IM20 Group Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | 160 |
| IM60 Group Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | 160 |
| Blank Control Group Participants received no intervention. | 160 |
| Total | 480 |
Baseline characteristics
| Characteristic | IM20 Group | IM60 Group | Blank Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 37.0 years STANDARD_DEVIATION 8.7 | 36.4 years STANDARD_DEVIATION 8.6 | 36.7 years STANDARD_DEVIATION 8.3 | 36.7 years STANDARD_DEVIATION 8.5 |
| Race/Ethnicity, Customized Han ethnicity | 158 Participants | 158 Participants | 158 Participants | 474 Participants |
| Race/Ethnicity, Customized minority ethnicity | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Region of Enrollment China Rural | 93 Participants | 98 Participants | 91 Participants | 282 Participants |
| Region of Enrollment China Urban | 67 Participants | 62 Participants | 69 Participants | 198 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 160 Participants | 160 Participants | 160 Participants | 480 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 158 | 0 / 156 |
| other Total, other adverse events | 12 / 158 | 11 / 156 |
| serious Total, serious adverse events | 0 / 158 | 0 / 156 |
Outcome results
Primary
Number and Rate of Participants With Anti-HBs Seroconversion at Month 7
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）. The accepted protective serum anti-HBs level was ≥10 mIU/ml.
Time frame: Month 7
Population: Exclusion of participants who did not received/competed vaccine or left the centers.150, 149 and 151 patients in the IM20, IM60 and blank control groups completed the followed-up at months 7 .
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IM20 Group | Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 | 142 Participants |
| IM60 Group | Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 | 138 Participants |
| Blank Control Group | Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 | 0 Participants |
Secondary
Anti-HBs Concentration at Month 12
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）.
Time frame: Month 12
Population: 133, 133 and 124 patients in the IM20, IM60 and blank control groups completed the followed-up at months 12 .
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IM20 Group | Anti-HBs Concentration at Month 12 | 470.5 mIU/mL |
| IM60 Group | Anti-HBs Concentration at Month 12 | 676.7 mIU/mL |
| Blank Control Group | Anti-HBs Concentration at Month 12 | 0.3 mIU/mL |
Secondary
Anti-HBs Concentration at Month 7
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）.
Time frame: Month 7
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IM20 Group | Anti-HBs Concentration at Month 7 | 909.6 mIU/mL |
| IM60 Group | Anti-HBs Concentration at Month 7 | 2022.5 mIU/mL |
| Blank Control Group | Anti-HBs Concentration at Month 7 | 0.3 mIU/mL |
Secondary
Number and Rate of Participants With Anti-HBs Seroconversion at Month 12
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）. The accepted protective serum anti-HBs level was ≥10 mIU/ml.
Time frame: Month 12
Population: 133, 133 and 124 patients in the IM20, IM60 and blank control groups completed the followed-up at months 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IM20 Group | Number and Rate of Participants With Anti-HBs Seroconversion at Month 12 | 119 Participants |
| IM60 Group | Number and Rate of Participants With Anti-HBs Seroconversion at Month 12 | 122 Participants |
| Blank Control Group | Number and Rate of Participants With Anti-HBs Seroconversion at Month 12 | 0 Participants |
Secondary
Occurrence of Adverse Events After Vaccination
Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B
Time frame: Within 7 days after the vaccination, at Month 0, 1, and 6
Population: 158 participants in the IM20 group and 156 in the IM60 group received the first injection. The blank control group was not vaccinated with hepatitis B vaccine, so adverse reactions of hepatitis B vaccine were not collected and analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IM20 Group | Occurrence of Adverse Events After Vaccination | 14 Participants |
| IM60 Group | Occurrence of Adverse Events After Vaccination | 13 Participants |
Secondary
Occurrence of Adverse Events After Vaccination
Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B
Time frame: Within 28 days after the vaccination, at Month 0, 1, and 6
Population: The blank control group was not vaccinated with hepatitis B vaccine, so adverse reactions of hepatitis B vaccine were not collected and analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IM20 Group | Occurrence of Adverse Events After Vaccination | 2 Participants |
| IM60 Group | Occurrence of Adverse Events After Vaccination | 2 Participants |
Secondary
Serious Adverse Events (SAE) Occurred During Month 12
Time frame: Month 0-12
Population: The blank control group was not vaccinated with hepatitis B vaccine, so adverse reactions of hepatitis B vaccine were not collected and analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IM20 Group | Serious Adverse Events (SAE) Occurred During Month 12 | 0 Participants |
| IM60 Group | Serious Adverse Events (SAE) Occurred During Month 12 | 0 Participants |
Other Pre-specified
Anti-HBs Concentration at Month 6 Before the Third Injection
Anti-HBs concentration at month 6 before the third injection by CMIA
Time frame: Month 6 before the third injection
Population: 155 and 150 patients in the IM20 and IM60 groups completed the followed-up at months 6 before the third injection.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IM20 Group | Anti-HBs Concentration at Month 6 Before the Third Injection | 126.3 mIU/mL |
| IM60 Group | Anti-HBs Concentration at Month 6 Before the Third Injection | 524.5 mIU/mL |
| Blank Control Group | Anti-HBs Concentration at Month 6 Before the Third Injection | 0.3 mIU/mL |
Other Pre-specified
Number and Rate of Participants With Anti-HBs High-level Response at Month 12
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.
Time frame: Month 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IM20 Group | Number and Rate of Participants With Anti-HBs High-level Response at Month 12 | 73 Participants |
| IM60 Group | Number and Rate of Participants With Anti-HBs High-level Response at Month 12 | 91 Participants |
| Blank Control Group | Number and Rate of Participants With Anti-HBs High-level Response at Month 12 | 0 Participants |
Other Pre-specified
Number and Rate of Participants With Anti-HBs High-level Response at Month 6 Before the Third Injection
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.
Time frame: Month 6 before the third injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IM20 Group | Number and Rate of Participants With Anti-HBs High-level Response at Month 6 Before the Third Injection | 27 Participants |
| IM60 Group | Number and Rate of Participants With Anti-HBs High-level Response at Month 6 Before the Third Injection | 44 Participants |
| Blank Control Group | Number and Rate of Participants With Anti-HBs High-level Response at Month 6 Before the Third Injection | 0 Participants |
Other Pre-specified
Number and Rate of Participants With Anti-HBs High-level Response at Month 7
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.
Time frame: Month 7
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IM20 Group | Number and Rate of Participants With Anti-HBs High-level Response at Month 7 | 111 Participants |
| IM60 Group | Number and Rate of Participants With Anti-HBs High-level Response at Month 7 | 116 Participants |
| Blank Control Group | Number and Rate of Participants With Anti-HBs High-level Response at Month 7 | 0 Participants |
Other Pre-specified
Number and Rate of Participants With Anti-HBs Seroconversion at Month 6 Before the Third Injection
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. The accepted protective serum anti-HBs level was ≥10 mIU/ml.
Time frame: Month 6 before the third injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IM20 Group | Number and Rate of Participants With Anti-HBs Seroconversion at Month 6 Before the Third Injection | 98 Participants |
| IM60 Group | Number and Rate of Participants With Anti-HBs Seroconversion at Month 6 Before the Third Injection | 109 Participants |
| Blank Control Group | Number and Rate of Participants With Anti-HBs Seroconversion at Month 6 Before the Third Injection | 0 Participants |