Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
Study Details
Study Description
Brief Summary
This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in methadone maintenance treatment patients.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
Comparison of 2 vaccination strategy against Hepatitis B in patients with Methadone Maintenance Treatment
Intervention:
Arm 1 : 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6;
Arm 2 : 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6.
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 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 Outcome Measures
- 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 vaccine
- Occurrence of Adverse Events After Vaccination [Within 28 days after the vaccination, at Month 0, 1, and 6]
Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine
- Anti-HBs Concentration at Month 18 [Month 18]
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 18 [Month 18]
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 30 [Month 30]
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 30 [Month 30]
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 42 [Month 42]
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 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
Other Outcome Measures
- 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.
- 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.
- Number and Rate of Participants With Anti-HBs High-level Response at Month 18 [Month 18]
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 30 [Month 30]
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 42 [Month 42]
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged between 18 and 70 years at the enrolment
-
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
-
Intolerance or allergy to any component of the vaccine
-
Any vaccination during the month preceding enrollment
-
Ongoing opportunistic infection
-
Liver disease
-
Hematological disorder
-
Cancer
-
Unexplained fever the week before enrollment
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shanxi Medical University
- 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.- 2012ZX10002001003004003
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Period Title: Overall Study | ||
STARTED | 98 | 98 |
COMPLETED | 60 | 61 |
NOT COMPLETED | 38 | 37 |
Baseline Characteristics
Arm/Group Title | IM 20μg Group | IM 60μg Group | Total |
---|---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Total of all reporting groups |
Overall Participants | 98 | 98 | 196 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
42.5
(7.5)
|
44.0
(7.5)
|
43.2
(7.5)
|
Sex: Female, Male (Count of Participants) | |||
Female |
23
23.5%
|
18
18.4%
|
41
20.9%
|
Male |
75
76.5%
|
80
81.6%
|
155
79.1%
|
Race/Ethnicity, Customized (Count of Participants) | |||
Han ethnicity |
76
77.6%
|
83
84.7%
|
159
81.1%
|
minority ethnicity |
22
22.4%
|
15
15.3%
|
37
18.9%
|
Region of Enrollment (Count of Participants) | |||
Urban |
76
77.6%
|
81
82.7%
|
157
80.1%
|
Rural |
22
22.4%
|
17
17.3%
|
39
19.9%
|
Outcome Measures
Title | Number and Rate 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 |
---|
73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7. |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Measure Participants | 73 | 71 |
Count of Participants [Participants] |
59
60.2%
|
62
63.3%
|
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 |
---|
73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7 . |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Measure Participants | 73 | 71 |
Mean (95% Confidence Interval) [mIU/mL] |
630.4
|
742.9
|
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 |
---|
60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12. |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Measure Participants | 60 | 61 |
Mean (95% Confidence Interval) [mIU/mL] |
125.9
|
182.2
|
Title | Number and Rate 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 |
---|
60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12. |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Measure Participants | 60 | 61 |
Count of Participants [Participants] |
41
41.8%
|
43
43.9%
|
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, at Month 0, 1, and 6 |
Outcome Measure Data
Analysis Population Description |
---|
196 patients were enrolled and randomized,195 patients received the first dose, 1 patients declined in IM60 group. |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Measure Participants | 98 | 97 |
Count of Participants [Participants] |
7
7.1%
|
8
8.2%
|
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 the vaccination, at Month 0, 1, and 6 |
Outcome Measure Data
Analysis Population Description |
---|
196 patients were enrolled and randomized,195 patients received the first dose, 1 patients declined in IM60 group. |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Measure Participants | 98 | 97 |
Count of Participants [Participants] |
2
2%
|
3
3.1%
|
Title | Number and Rate 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 |
---|
73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7. |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Measure Participants | 73 | 71 |
Count of Participants [Participants] |
31
31.6%
|
40
40.8%
|
Title | Number and Rate 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 |
---|
60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12. |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Measure Participants | 60 | 61 |
Count of Participants [Participants] |
13
13.3%
|
20
20.4%
|
Title | Anti-HBs Concentration at Month 18 |
---|---|
Description | The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay ) |
Time Frame | Month 18 |
Outcome Measure Data
Analysis Population Description |
---|
47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 12. |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Measure Participants | 47 | 43 |
Mean (95% Confidence Interval) [mIU/mL] |
382.2
|
490.5
|
Title | Number and Rate of Participants With Anti-HBs Seroconversion at Month 18 |
---|---|
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 18 |
Outcome Measure Data
Analysis Population Description |
---|
47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 12. |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Measure Participants | 47 | 43 |
Count of Participants [Participants] |
29
29.6%
|
29
29.6%
|
Title | Number and Rate of Participants With Anti-HBs High-level Response at Month 18 |
---|---|
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 18 |
Outcome Measure Data
Analysis Population Description |
---|
47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 12. |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Measure Participants | 47 | 43 |
Count of Participants [Participants] |
9
9.2%
|
14
14.3%
|
Title | Anti-HBs Concentration at Month 30 |
---|---|
Description | The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay ) |
Time Frame | Month 30 |
Outcome Measure Data
Analysis Population Description |
---|
46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 12. |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Measure Participants | 46 | 42 |
Mean (95% Confidence Interval) [mIU/mL] |
239.9
|
306.4
|
Title | Number and Rate of Participants With Anti-HBs Seroconversion at Month 30 |
---|---|
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 30 |
Outcome Measure Data
Analysis Population Description |
---|
46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 12. |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Measure Participants | 46 | 42 |
Count of Participants [Participants] |
20
20.4%
|
25
25.5%
|
Title | Anti-HBs Concentration at Month 42 |
---|---|
Description | The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay ) |
Time Frame | Month 42 |
Outcome Measure Data
Analysis Population Description |
---|
45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 12. |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Measure Participants | 45 | 40 |
Mean (95% Confidence Interval) [mIU/mL] |
88.6
|
97.7
|
Title | Number and Rate 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 |
---|
45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 12. |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Measure Participants | 45 | 40 |
Count of Participants [Participants] |
14
14.3%
|
20
20.4%
|
Title | Number and Rate of Participants With Anti-HBs High-level Response at Month 30 |
---|---|
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 30 |
Outcome Measure Data
Analysis Population Description |
---|
46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 12. |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Measure Participants | 46 | 42 |
Count of Participants [Participants] |
6
6.1%
|
11
11.2%
|
Title | Number and Rate of Participants With Anti-HBs High-level Response at Month 42 |
---|---|
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 42 |
Outcome Measure Data
Analysis Population Description |
---|
45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 12. |
Arm/Group Title | IM 20μg Group | IM 60μg Group |
---|---|---|
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
Measure Participants | 45 | 40 |
Count of Participants [Participants] |
4
4.1%
|
8
8.2%
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | IM 20μg Group | IM 60μg Group | ||
Arm/Group Description | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | ||
All Cause Mortality |
||||
IM 20μg Group | IM 60μg Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/98 (0%) | 0/97 (0%) | ||
Serious Adverse Events |
||||
IM 20μg Group | IM 60μg Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/98 (0%) | 0/97 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
IM 20μg Group | IM 60μg Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 7/98 (7.1%) | 8/97 (8.2%) | ||
Musculoskeletal and connective tissue disorders | ||||
pain | 4/98 (4.1%) | 5/97 (5.2%) | ||
Skin and subcutaneous tissue disorders | ||||
Erythema | 5/98 (5.1%) | 5/97 (5.2%) | ||
Edema | 3/98 (3.1%) | 4/97 (4.1%) |
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 |
- 2012ZX10002001003004003