Trial Outcomes & Findings for Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients (NCT NCT02963714)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

352 participants

Primary outcome timeframe

Month 7

Results posted on

2022-02-14

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	176	176
Overall Study COMPLETED	126	126
Overall Study NOT COMPLETED	50	50

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IM 20μg Group n=176 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=176 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	Total n=352 Participants Total of all reporting groups
Age, Continuous	43.5 years STANDARD_DEVIATION 12.2 • n=5 Participants	45.5 years STANDARD_DEVIATION 12.0 • n=7 Participants	44.5 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	88 Participants n=7 Participants	164 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants	88 Participants n=7 Participants	188 Participants n=5 Participants
Race/Ethnicity, Customized Han ethnicity	176 Participants n=5 Participants	175 Participants n=7 Participants	351 Participants n=5 Participants
Race/Ethnicity, Customized Hui ethnicity	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment China · Urban	89 Participants n=5 Participants	101 Participants n=7 Participants	190 Participants n=5 Participants
Region of Enrollment China · Rural	87 Participants n=5 Participants	75 Participants n=7 Participants	162 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 7

Outcome measures

Outcome measures
Measure	IM 20μg Group n=141 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=143 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Anti-HBs Seroconversion Rate at Month 7	118 Participants	132 Participants

SECONDARY outcome

Timeframe: Month 42

Outcome measures

Outcome measures
Measure	IM 20μg Group n=109 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=102 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Anti-HBs Seroconversion Rate at Month 42	33 Participants	40 Participants

SECONDARY outcome

Timeframe: Month 36

Outcome measures

Outcome measures
Measure	IM 20μg Group n=115 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=106 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Anti-HBs Seroconversion Rate at Month 36	41 Participants	51 Participants

SECONDARY outcome

Timeframe: Month 30

Outcome measures

Outcome measures
Measure	IM 20μg Group n=118 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=108 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Anti-HBs Seroconversion Rate at Month 30	48 Participants	62 Participants

SECONDARY outcome

Timeframe: Month 24

Outcome measures

Outcome measures
Measure	IM 20μg Group n=120 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=118 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Anti-HBs Seroconversion Rate at Month 24	54 Participants	78 Participants

SECONDARY outcome

Timeframe: Month 7

Anti-HBs concentration at month 7 as measured by CMIA

Outcome measures

Outcome measures
Measure	IM 20μg Group n=141 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=143 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	1488.5 mIU/mL Interval 1053.7 to 1923.4	1916.6 mIU/mL Interval 1413.7 to 2419.4

SECONDARY outcome

Timeframe: Month 12

Anti-HBs concentration at month 12 as measured by CMIA

Outcome measures

Outcome measures
Measure	IM 20μg Group n=126 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=126 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	407.8 mIU/mL Interval 227.0 to 588.7	476.2 mIU/mL Interval 290.3 to 662.1

SECONDARY outcome

Timeframe: Month 12

Outcome measures

Outcome measures
Measure	IM 20μg Group n=126 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=126 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Anti-HBs Seroconversion Rate at Month 12	109 Participants	114 Participants

SECONDARY outcome

Timeframe: Within 7 days after the vaccination

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

Outcome measures

Outcome measures
Measure	IM 20μg Group n=174 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=175 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	14 Participants	14 Participants

SECONDARY outcome

Timeframe: Within 28 days after the vaccination

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

Outcome measures

Outcome measures
Measure	IM 20μg Group n=174 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=175 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: Month 18

Outcome measures

Outcome measures
Measure	IM 20μg Group n=127 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=126 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Anti-HBs Seroconversion Rate at Month 18	77 Participants	96 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 7

Outcome measures

Outcome measures
Measure	IM 20μg Group n=141 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=143 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
High-level Response Rate at Month 7	88 Participants	107 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 12

Outcome measures

Outcome measures
Measure	IM 20μg Group n=126 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=126 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
High-level Response Rate at Month 12	67 Participants	82 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 18

Outcome measures

Outcome measures
Measure	IM 20μg Group n=127 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=126 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
High-level Response Rate at Month 18	30 Participants	38 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 30

Outcome measures

Outcome measures
Measure	IM 20μg Group n=118 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=108 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
High-level Response Rate at Month 30	15 Participants	19 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 36

Outcome measures

Outcome measures
Measure	IM 20μg Group n=115 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=106 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
High-level Response Rate at Month 36	14 Participants	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 42

Outcome measures

Outcome measures
Measure	IM 20μg Group n=109 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=102 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
High-level Response Rate at Month 42	8 Participants	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 24

Outcome measures

Outcome measures
Measure	IM 20μg Group n=120 Participants Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.	IM 60μg Group n=118 Participants Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
High-level Response Rate at Month 24	19 Participants	23 Participants

Adverse Events

IM 20μg Group

Serious events: 0 serious events

Other events: 8 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=174 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=175 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	4.6% 8/174	4.6% 8/175

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