Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults
Study Details
Study Description
Brief Summary
Uptake, adherence, and completion of vaccination among HIV-infected adults 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 HIV-infected adults from HBV infection. And the persistence of immunity induced by hepatitis B vaccination remains a challenge.
This is a randomized, open-label trial, conducted among HIV-infected adults with drug rehabilitation. This study will compare the immunogenicity, immune persistence, and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among HIV-infected adults.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
Participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis B vaccine group or 60µg recombinant hepatitis B vaccine group. The 20 µg group will receive three intramuscular injections of the 20 µg recombinant hepatitis B vaccine, while the 60 µg group will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6, respectively. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 60 µg dose hepatitis B vaccine 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 |
Biological: 60 µg dose hepatitis B vaccine
three-dose, 60 µg per dose
|
Experimental: 20 µg dose hepatitis B vaccine 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 |
Biological: 20 µg dose hepatitis B vaccine
three-dose, 20 µg per dose
|
Outcome Measures
Primary Outcome Measures
- Number and Percentage 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 Outcome Measures
- Anti-HBs Concentration at Month 7 [Month 7]
The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay ).
- Number and Percentage 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.
- Anti-HBs Concentration at Month 12 [Month 12]
The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay).
- Occurrence of Adverse Events After Vaccination [Within 7 days after the vaccination]
Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine
- Occurrence of Adverse Events After Vaccination [Within 28 days after vaccination]
Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine
- Serious Adverse Events (SAE) Occurred During 42 Month [Month 0-42]
Occurrence of Serious adverse events (SAE) within 42 month after vaccination with the hepatitis B
Other Outcome Measures
- Number and Percentage 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.
- Number and Percentage 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.
- Number and Percentage of Participants With Anti-HBs Antibodies 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.
- 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 as measured by CMIA(Chemiluminescent Microparticle Immunoassay).
- Number and Percentage 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 Percentage of Participants With Anti-HBs Seroconversion at Month 42 [Month 42]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
HIV-infected
-
Aged between 18 and 70 years
-
Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
-
Willing to adhere to the study protocol
Exclusion Criteria:
-
Being pregnant
-
Acute cytolysis in the last three months before enrollment
-
Any vaccination before or during the month preceding enrollment
-
Any Intolerance or allergy to any component of the vaccine
-
Ongoing opportunistic infection
-
Hematological disorder
-
Cancer
-
Unexplained fever the week before enrollment
-
Immunosuppressive or immunomodulating treatment in the last six months
-
Liver disease
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Suping Wang
- Centers for Disease Control and Prevention, China
Investigators
- Principal Investigator: Suping Wang, Shanxi Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2012ZX10002001003004004
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | 60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine |
---|---|---|
Arm/Group Description | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose |
Period Title: Overall Study | ||
STARTED | 91 | 91 |
COMPLETED | 60 | 65 |
NOT COMPLETED | 31 | 26 |
Baseline Characteristics
Arm/Group Title | 60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine | Total |
---|---|---|---|
Arm/Group Description | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose | Total of all reporting groups |
Overall Participants | 91 | 91 | 182 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
40.5
(11.4)
|
38.2
(10.6)
|
39.3
(11.1)
|
Sex: Female, Male (Count of Participants) | |||
Female |
42
46.2%
|
33
36.3%
|
75
41.2%
|
Male |
49
53.8%
|
58
63.7%
|
107
58.8%
|
Race/Ethnicity, Customized (Count of Participants) | |||
Han ethnicity |
32
35.2%
|
24
26.4%
|
56
30.8%
|
Zhuang ethnicity |
49
53.8%
|
62
68.1%
|
111
61%
|
others |
10
11%
|
5
5.5%
|
15
8.2%
|
Outcome Measures
Title | Number and Percentage of Participants With Anti-HBs Seroconversion at Month 7 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
83 and 82 patients in the IM60(60μg recombinant hepatitis B vaccine) and IM20(20μg recombinant hepatitis B vaccine) groups completed the followed-up at months 7. |
Arm/Group Title | 60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine |
---|---|---|
Arm/Group Description | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose |
Measure Participants | 83 | 82 |
Count of Participants [Participants] |
75
82.4%
|
69
75.8%
|
Title | Anti-HBs Concentration at Month 7 |
---|---|
Description | The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay ). |
Time Frame | Month 7 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | 60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine |
---|---|---|
Arm/Group Description | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose |
Measure Participants | 83 | 82 |
Mean (95% Confidence Interval) [mIU/mL] |
623.3
|
469.4
|
Title | Number and Percentage of Participants With Anti-HBs Seroconversion at Month 12 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | 60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine |
---|---|---|
Arm/Group Description | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose |
Measure Participants | 74 | 68 |
Count of Participants [Participants] |
55
60.4%
|
50
54.9%
|
Title | Anti-HBs Concentration at Month 12 |
---|---|
Description | The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay). |
Time Frame | Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | 60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine |
---|---|---|
Arm/Group Description | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose |
Measure Participants | 74 | 68 |
Mean (95% Confidence Interval) [mIU/ml] |
290.4
|
264.4
|
Title | Occurrence of Adverse Events After Vaccination |
---|---|
Description | Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine |
Time Frame | Within 7 days after the vaccination |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | 60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine |
---|---|---|
Arm/Group Description | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose |
Measure Participants | 88 | 88 |
pain |
5
5.5%
|
5
5.5%
|
erythema |
6
6.6%
|
5
5.5%
|
edema |
5
5.5%
|
4
4.4%
|
induration |
4
4.4%
|
4
4.4%
|
Title | Occurrence of Adverse Events After Vaccination |
---|---|
Description | Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine |
Time Frame | Within 28 days after vaccination |
Outcome Measure Data
Analysis Population Description |
---|
Safety analysis was performed on all included participants. |
Arm/Group Title | 60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine |
---|---|---|
Arm/Group Description | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose |
Measure Participants | 88 | 88 |
fever |
1
1.1%
|
1
1.1%
|
headache |
2
2.2%
|
1
1.1%
|
Title | Serious Adverse Events (SAE) Occurred During 42 Month |
---|---|
Description | Occurrence of Serious adverse events (SAE) within 42 month after vaccination with the hepatitis B |
Time Frame | Month 0-42 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | 60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine |
---|---|---|
Arm/Group Description | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose |
Measure Participants | 88 | 88 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
Title | Number and Percentage of Participants With Anti-HBs High-level Response at Month 7 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | 60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine |
---|---|---|
Arm/Group Description | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose |
Measure Participants | 83 | 82 |
Count of Participants [Participants] |
62
68.1%
|
54
59.3%
|
Title | Number and Percentage of Participants With Anti-HBs High-level Response at Month 12 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | 60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine |
---|---|---|
Arm/Group Description | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose |
Measure Participants | 74 | 68 |
Count of Participants [Participants] |
34
37.4%
|
26
28.6%
|
Title | Number and Percentage of Participants With Anti-HBs Antibodies at Month 6 Before the Third Injection |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
83 and 70 patients in the IM60 and IM20 groups completed the followed-up at month 6 before the third injection. |
Arm/Group Title | 60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine |
---|---|---|
Arm/Group Description | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose |
Measure Participants | 83 | 80 |
Count of Participants [Participants] |
65
71.4%
|
61
67%
|
Title | Anti-HBs Concentration at Month 6 Before the Third Injection |
---|---|
Description | Anti-HBs concentration at month 6 before the third injection as measured by CMIA(Chemiluminescent Microparticle Immunoassay). |
Time Frame | Month 6 before the third injection |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | 60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine |
---|---|---|
Arm/Group Description | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose |
Measure Participants | 83 | 80 |
Mean (95% Confidence Interval) [mIU/ml] |
148.9
|
130.6
|
Title | Number and Percentage of Participants With Anti-HBs High-level Response at Month 6 Before the Third Injection |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | 60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine |
---|---|---|
Arm/Group Description | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose |
Measure Participants | 83 | 80 |
Count of Participants [Participants] |
29
31.9%
|
27
29.7%
|
Title | Number and Percentage of Participants With Anti-HBs Seroconversion at Month 42 |
---|---|
Description | 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 42 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | 60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine |
---|---|---|
Arm/Group Description | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose |
Measure Participants | 60 | 65 |
Count of Participants [Participants] |
31
34.1%
|
29
31.9%
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | 60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine | ||
Arm/Group Description | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose | ||
All Cause Mortality |
||||
60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/88 (0%) | 0/88 (0%) | ||
Serious Adverse Events |
||||
60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/88 (0%) | 0/88 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
60 µg Dose Hepatitis B Vaccine | 20 µg Dose Hepatitis B Vaccine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 8/88 (9.1%) | 6/88 (6.8%) | ||
Musculoskeletal and connective tissue disorders | ||||
Pain | 5/88 (5.7%) | 5/88 (5.7%) | ||
Skin and subcutaneous tissue disorders | ||||
erythema | 6/88 (6.8%) | 5/88 (5.7%) | ||
edema | 5/88 (5.7%) | 4/88 (4.5%) | ||
induration | 4/88 (4.5%) | 4/88 (4.5%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Suping Wang, PhD |
---|---|
Organization | Shanxi Medical University |
Phone | #86-351-4135103 |
spwang88@163.com |
- 2012ZX10002001003004004