CClinicalTrials.gg
Sign In
CompletedNCT02963714Updated Feb 14, 2022Results posted

Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients

A Phase 4 interventional study of 60 µg dose hepatitis B vaccine and 20 µg dose hepatitis B vaccine in Hepatitis B Vaccine, sponsored by Suping Wang. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-02-14.

Sponsored by Suping Wang · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
352
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates are inadequate and persistence of immunity remains a challenge.

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 hemodialysis patients.

Read the 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.

02

Conditions studied

  • Hepatitis B Vaccine

Keywords

  • Hepatitis B, Vaccine
  • Randomized Controlled Trial
  • Hemodialysis
  • Immunogenicity
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 352 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Suping Wang is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Having end-stage renal disease (ESRD) on maintenance hemodialysis
  • Aged between 18 and 70 years at enrollment
  • 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

Exclusion Criteria:

  • Being pregnant
  • Acute cytolysis in the last three months before enrollment
  • Any vaccination during the month preceding enrollment
  • Intolerance or allergy to any component of the vaccine
  • Ongoing opportunistic infection
  • Hepatitis C virus infection
  • Hematological disorder
  • Cancer
  • Unexplained fever the week before enrollment
  • Immunosuppressive or immunomodulating treatment in the last six months
  • Renal transplantation or upcoming renal transplantation
  • Liver disease
  • Other immunocompromised condition not related to ESRD
  • An expected survival of \< 6 months
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
352 participants (actual)

Study arms

  • 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

  • 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

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

06

What researchers measure

Primary outcomes

  1. Anti-HBs Seroconversion Rate at Month 7

    Time frame: Month 7

Secondary outcomes

  1. Anti-HBs Seroconversion Rate at Month 42

    Time frame: Month 42

  2. Anti-HBs Seroconversion Rate at Month 36

    Time frame: Month 36

  3. Anti-HBs Seroconversion Rate at Month 30

    Time frame: Month 30

  4. Anti-HBs Seroconversion Rate at Month 24

    Time frame: Month 24

  5. Anti-HBs Concentration at Month 7

    Anti-HBs concentration at month 7 as measured by CMIA

    Time frame: Month 7

  6. Anti-HBs Concentration at Month 12

    Anti-HBs concentration at month 12 as measured by CMIA

    Time frame: Month 12

  7. Anti-HBs Seroconversion Rate at Month 12

    Time frame: Month 12

  8. Occurrence of Adverse Events After Vaccination

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

    Time frame: Within 7 days after the vaccination

  9. Occurrence of Adverse Events After Vaccination

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

    Time frame: Within 28 days after the vaccination

  10. Anti-HBs Seroconversion Rate at Month 18

    Time frame: Month 18

Other outcomes

  1. High-level Response Rate at Month 7

    Time frame: Month 7

  2. High-level Response Rate at Month 12

    Time frame: Month 12

  3. High-level Response Rate at Month 18

    Time frame: Month 18

  4. High-level Response Rate at Month 30

    Time frame: Month 30

  5. High-level Response Rate at Month 36

    Time frame: Month 36

  6. High-level Response Rate at Month 42

    Time frame: Month 42

  7. High-level Response Rate at Month 24

    Time frame: Month 24

07

Results

Posted Feb 14, 2022

Participant flow

Participant flow — Overall Study
MilestoneIM 20μg GroupIM 60μg Group
Started176176
Completed126126
Not completed5050

Outcome measures

PrimaryAnti-HBs Seroconversion Rate at Month 7
Time frame:
Month 7
Reported as:
Count of participants · Participants
Anti-HBs Seroconversion Rate at Month 7
ParticipantsIM 20μg GroupIM 60μg Group
Anti-HBs Seroconversion Rate at Month 7118132
SecondaryAnti-HBs Seroconversion Rate at Month 42
Time frame:
Month 42
Reported as:
Count of participants · Participants
Anti-HBs Seroconversion Rate at Month 42
ParticipantsIM 20μg GroupIM 60μg Group
Anti-HBs Seroconversion Rate at Month 423340
SecondaryAnti-HBs Seroconversion Rate at Month 36
Time frame:
Month 36
Reported as:
Count of participants · Participants
Anti-HBs Seroconversion Rate at Month 36
ParticipantsIM 20μg GroupIM 60μg Group
Anti-HBs Seroconversion Rate at Month 364151
SecondaryAnti-HBs Seroconversion Rate at Month 30
Time frame:
Month 30
Reported as:
Count of participants · Participants
Anti-HBs Seroconversion Rate at Month 30
ParticipantsIM 20μg GroupIM 60μg Group
Anti-HBs Seroconversion Rate at Month 304862
SecondaryAnti-HBs Seroconversion Rate at Month 24
Time frame:
Month 24
Reported as:
Count of participants · Participants
Anti-HBs Seroconversion Rate at Month 24
ParticipantsIM 20μg GroupIM 60μg Group
Anti-HBs Seroconversion Rate at Month 245478
SecondaryAnti-HBs Concentration at Month 7

Anti-HBs concentration at month 7 as measured by CMIA

Time frame:
Month 7
Reported as:
Mean · mIU/mL
Anti-HBs Concentration at Month 7
mIU/mLIM 20μg GroupIM 60μg Group
Anti-HBs Concentration at Month 71488.5 (1053.7 to 1923.4)1916.6 (1413.7 to 2419.4)
SecondaryAnti-HBs Concentration at Month 12

Anti-HBs concentration at month 12 as measured by CMIA

Time frame:
Month 12
Reported as:
Mean · mIU/mL
Anti-HBs Concentration at Month 12
mIU/mLIM 20μg GroupIM 60μg Group
Anti-HBs Concentration at Month 12407.8 (227.0 to 588.7)476.2 (290.3 to 662.1)
SecondaryAnti-HBs Seroconversion Rate at Month 12
Time frame:
Month 12
Reported as:
Count of participants · Participants
Anti-HBs Seroconversion Rate at Month 12
ParticipantsIM 20μg GroupIM 60μg Group
Anti-HBs Seroconversion Rate at Month 12109114
SecondaryOccurrence of Adverse Events After Vaccination

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

Time frame:
Within 7 days after the vaccination
Reported as:
Count of participants · Participants
Occurrence of Adverse Events After Vaccination
ParticipantsIM 20μg GroupIM 60μg Group
Occurrence of Adverse Events After Vaccination1414
SecondaryOccurrence of Adverse Events After Vaccination

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

Time frame:
Within 28 days after the vaccination
Reported as:
Count of participants · Participants
Occurrence of Adverse Events After Vaccination
ParticipantsIM 20μg GroupIM 60μg Group
Occurrence of Adverse Events After Vaccination78
SecondaryAnti-HBs Seroconversion Rate at Month 18
Time frame:
Month 18
Reported as:
Count of participants · Participants
Anti-HBs Seroconversion Rate at Month 18
ParticipantsIM 20μg GroupIM 60μg Group
Anti-HBs Seroconversion Rate at Month 187796
Other pre-specifiedHigh-level Response Rate at Month 7
Time frame:
Month 7
Reported as:
Count of participants · Participants
High-level Response Rate at Month 7
ParticipantsIM 20μg GroupIM 60μg Group
High-level Response Rate at Month 788107
Other pre-specifiedHigh-level Response Rate at Month 12
Time frame:
Month 12
Reported as:
Count of participants · Participants
High-level Response Rate at Month 12
ParticipantsIM 20μg GroupIM 60μg Group
High-level Response Rate at Month 126782
Other pre-specifiedHigh-level Response Rate at Month 18
Time frame:
Month 18
Reported as:
Count of participants · Participants
High-level Response Rate at Month 18
ParticipantsIM 20μg GroupIM 60μg Group
High-level Response Rate at Month 183038
Other pre-specifiedHigh-level Response Rate at Month 30
Time frame:
Month 30
Reported as:
Count of participants · Participants
High-level Response Rate at Month 30
ParticipantsIM 20μg GroupIM 60μg Group
High-level Response Rate at Month 301519
Other pre-specifiedHigh-level Response Rate at Month 36
Time frame:
Month 36
Reported as:
Count of participants · Participants
High-level Response Rate at Month 36
ParticipantsIM 20μg GroupIM 60μg Group
High-level Response Rate at Month 361414
Other pre-specifiedHigh-level Response Rate at Month 42
Time frame:
Month 42
Reported as:
Count of participants · Participants
High-level Response Rate at Month 42
ParticipantsIM 20μg GroupIM 60μg Group
High-level Response Rate at Month 42810
Other pre-specifiedHigh-level Response Rate at Month 24
Time frame:
Month 24
Reported as:
Count of participants · Participants
High-level Response Rate at Month 24
ParticipantsIM 20μg GroupIM 60μg Group
High-level Response Rate at Month 241923

Adverse events

Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
IM 20μg Group0/174 (0%)0/174 (0%)8/174 (4.6%)
IM 60μg Group0/175 (0%)0/175 (0%)8/175 (4.6%)
Most frequent other events
Most frequent other events
EventIM 20μg GroupIM 60μg Group
painMusculoskeletal and connective tissue disorders8/1748/175

Baseline characteristics

Age, Continuous
Age, Continuous(years)IM 20μg GroupIM 60μg GroupTotal
Mean43.5 ± 12.245.5 ± 12.044.5 ± 12.1
Sex: Female, Male
Sex: Female, Male(Participants)IM 20μg GroupIM 60μg GroupTotal
Female7688164
Male10088188
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)IM 20μg GroupIM 60μg GroupTotal
Han ethnicity176175351
Hui ethnicity011
Region of Enrollment
Region of Enrollment(Participants)IM 20μg GroupIM 60μg GroupTotal
China — Urban89101190
China — Rural8775162
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Feng Y, Shi X, Shi J, Gao L, Liu G, Cheng Y, Pan M, Li C, Wang J, Guo X, Zhang Y, Liang X, Wang S. Immunogenicity, antibody persistence, and safety of the 60 mug hepatitis B vaccine in hemodialysis patients: a multicenter, randomized, double-blind, parallel-controlled trial. Expert Rev Vaccines. 2017 Oct;16(10):1045-1052. doi: 10.1080/14760584.2017.1367667. Epub 2017 Aug 21. PubMed 28803502 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02963714
Lead sponsor
Suping Wang
Collaborators
Centers for Disease Control and Prevention, China
Responsible party
Suping Wang (Professor, Shanxi Medical University) — Sponsor-investigator
First posted
Nov 15, 2016
Start date
Dec 2014
Primary completion
Jul 2015
Completion
Jul 2018
Results posted
Feb 14, 2022
Last update
Feb 14, 2022

Study contacts

Suping Wang
principal investigator · Shanxi Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hepatitis A→

Other studies from this sponsor

Suping Wang

Start the discussion