Trial Outcomes & Findings for Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients (NCT NCT02991599)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

196 participants

Primary outcome timeframe

Month 7

Results posted on

2021-12-23

Participant Flow

Participant milestones

Participant milestones
Measure	IM 20μg Group Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Overall Study STARTED	98	98
Overall Study COMPLETED	60	61
Overall Study NOT COMPLETED	38	37

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IM 20μg Group n=98 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=98 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	Total n=196 Participants Total of all reporting groups
Age, Continuous	42.5 years STANDARD_DEVIATION 7.5 • n=93 Participants	44.0 years STANDARD_DEVIATION 7.5 • n=4 Participants	43.2 years STANDARD_DEVIATION 7.5 • n=27 Participants
Sex: Female, Male Female	23 Participants n=93 Participants	18 Participants n=4 Participants	41 Participants n=27 Participants
Sex: Female, Male Male	75 Participants n=93 Participants	80 Participants n=4 Participants	155 Participants n=27 Participants
Race/Ethnicity, Customized Han ethnicity	76 Participants n=93 Participants	83 Participants n=4 Participants	159 Participants n=27 Participants
Race/Ethnicity, Customized minority ethnicity	22 Participants n=93 Participants	15 Participants n=4 Participants	37 Participants n=27 Participants
Region of Enrollment China · Urban	76 Participants n=93 Participants	81 Participants n=4 Participants	157 Participants n=27 Participants
Region of Enrollment China · Rural	22 Participants n=93 Participants	17 Participants n=4 Participants	39 Participants n=27 Participants

PRIMARY outcome

Timeframe: Month 7

Population: 73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 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.

Outcome measures

Outcome measures
Measure	IM 20μg Group n=73 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=71 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Number and Rate of Participants With Anti-HBs Seroconversion at Month 7	59 Participants	62 Participants

SECONDARY outcome

Timeframe: Month 7

Population: 73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7 .

The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）

Outcome measures

Outcome measures
Measure	IM 20μg Group n=73 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=71 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Anti-HBs Concentration at Month 7	630.4 mIU/mL Interval 157.7 to 1103.0	742.9 mIU/mL Interval 187.0 to 1298.9

SECONDARY outcome

Timeframe: Month 12

Population: 60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12.

The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）

Outcome measures

Outcome measures
Measure	IM 20μg Group n=60 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=61 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Anti-HBs Concentration at Month 12	125.9 mIU/mL Interval 49.9 to 202.0	182.2 mIU/mL Interval 97.7 to 266.6

SECONDARY outcome

Timeframe: Month 12

Population: 60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 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

Outcome measures

Outcome measures
Measure	IM 20μg Group n=60 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=61 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Number and Rate of Participants With Anti-HBs Seroconversion at Month 12	41 Participants	43 Participants

SECONDARY outcome

Timeframe: Within 7 days after the vaccination, at Month 0, 1, and 6

Population: 196 patients were enrolled and randomized,195 patients received the first dose, 1 patients declined in IM60 group.

Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine

Outcome measures

Outcome measures
Measure	IM 20μg Group n=98 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=97 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Occurrence of Adverse Events After Vaccination	7 Participants	8 Participants

SECONDARY outcome

Timeframe: Within 28 days after the vaccination, at Month 0, 1, and 6

Population: 196 patients were enrolled and randomized,195 patients received the first dose, 1 patients declined in IM60 group.

Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine

Outcome measures

Outcome measures
Measure	IM 20μg Group n=98 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=97 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Occurrence of Adverse Events After Vaccination	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Month 18

Population: 47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 12.

The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）

Outcome measures

Outcome measures
Measure	IM 20μg Group n=47 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=43 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Anti-HBs Concentration at Month 18	382.2 mIU/mL Interval 196.3 to 960.7	490.5 mIU/mL Interval 72.4 to 1053.4

SECONDARY outcome

Timeframe: Month 18

Population: 47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 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

Outcome measures

Outcome measures
Measure	IM 20μg Group n=47 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=43 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Number and Rate of Participants With Anti-HBs Seroconversion at Month 18	29 Participants	29 Participants

SECONDARY outcome

Timeframe: Month 30

Population: 46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 12.

The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）

Outcome measures

Outcome measures
Measure	IM 20μg Group n=46 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=42 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Anti-HBs Concentration at Month 30	239.9 mIU/mL Interval 119.3 to 599.1	306.4 mIU/mL Interval 60.2 to 579.3

SECONDARY outcome

Timeframe: Month 30

Population: 46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 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

Outcome measures

Outcome measures
Measure	IM 20μg Group n=46 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=42 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Number and Rate of Participants With Anti-HBs Seroconversion at Month 30	20 Participants	25 Participants

SECONDARY outcome

Timeframe: Month 42

Population: 45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 12.

The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）

Outcome measures

Outcome measures
Measure	IM 20μg Group n=45 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=40 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Anti-HBs Concentration at Month 42	88.6 mIU/mL Interval 12.4 to 170.0	97.7 mIU/mL Interval 17.5 to 186.6

SECONDARY outcome

Timeframe: Month 42

Population: 45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 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

Outcome measures

Outcome measures
Measure	IM 20μg Group n=45 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=40 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Number and Rate of Participants With Anti-HBs Seroconversion at Month 42	14 Participants	20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 7

Population: 73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7.

The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.

Outcome measures

Outcome measures
Measure	IM 20μg Group n=73 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=71 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Number and Rate of Participants With Anti-HBs High-level Response at Month 7	31 Participants	40 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 12

Population: 60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12.

The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.

Outcome measures

Outcome measures
Measure	IM 20μg Group n=60 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=61 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Number and Rate of Participants With Anti-HBs High-level Response at Month 12	13 Participants	20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 18

Population: 47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 12.

The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.

Outcome measures

Outcome measures
Measure	IM 20μg Group n=47 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=43 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Number and Rate of Participants With Anti-HBs High-level Response at Month 18	9 Participants	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 30

Population: 46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 12.

The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.

Outcome measures

Outcome measures
Measure	IM 20μg Group n=46 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=42 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Number and Rate of Participants With Anti-HBs High-level Response at Month 30	6 Participants	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 42

Population: 45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 12.

The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.

Outcome measures

Outcome measures
Measure	IM 20μg Group n=45 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=40 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Number and Rate of Participants With Anti-HBs High-level Response at Month 42	4 Participants	8 Participants

Adverse Events

IM 20μg Group

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

IM 60μg Group

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IM 20μg Group n=98 participants at risk Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=97 participants at risk Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Musculoskeletal and connective tissue disorders pain	4.1% 4/98	5.2% 5/97
Skin and subcutaneous tissue disorders Erythema	5.1% 5/98	5.2% 5/97
Skin and subcutaneous tissue disorders Edema	3.1% 3/98	4.1% 4/97

Additional Information

Suping Wang, PhD

Shanxi Medical University

Phone: #86-351-4135103

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place