Trial Outcomes & Findings for Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults (NCT NCT03316807)
NCT ID: NCT03316807
Last Updated: 2022-03-11
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
182 participants
Primary outcome timeframe
Month 7
Results posted on
2022-03-11
Participant Flow
Participant milestones
| Measure |
20 µg Dose Hepatitis B Vaccine
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
|
60 µg Dose Hepatitis B Vaccine
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
|
|---|---|---|
|
Overall Study
STARTED
|
91
|
91
|
|
Overall Study
COMPLETED
|
65
|
60
|
|
Overall Study
NOT COMPLETED
|
26
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults
Baseline characteristics by cohort
| Measure |
60 µg Dose Hepatitis B Vaccine
n=91 Participants
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 Dose Hepatitis B Vaccine
n=91 Participants
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
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
38.2 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
39.3 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Han ethnicity
|
32 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Zhuang ethnicity
|
49 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
others
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 7Population: 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.
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
| Measure |
60 µg Dose Hepatitis B Vaccine
n=83 Participants
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 Dose Hepatitis B Vaccine
n=82 Participants
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
|
|---|---|---|
|
Number and Percentage of Participants With Anti-HBs Seroconversion at Month 7
|
75 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: Month 7The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay ).
Outcome measures
| Measure |
60 µg Dose Hepatitis B Vaccine
n=83 Participants
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 Dose Hepatitis B Vaccine
n=82 Participants
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
|
|---|---|---|
|
Anti-HBs Concentration at Month 7
|
623.3 mIU/mL
Interval 427.7 to 836.9
|
469.4 mIU/mL
Interval 326.8 to 611.9
|
SECONDARY outcome
Timeframe: Month 12The 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
| Measure |
60 µg Dose Hepatitis B Vaccine
n=74 Participants
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 Dose Hepatitis B Vaccine
n=68 Participants
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
|
|---|---|---|
|
Number and Percentage of Participants With Anti-HBs Seroconversion at Month 12
|
55 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Month 12The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）.
Outcome measures
| Measure |
60 µg Dose Hepatitis B Vaccine
n=74 Participants
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 Dose Hepatitis B Vaccine
n=68 Participants
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
|
|---|---|---|
|
Anti-HBs Concentration at Month 12
|
290.4 mIU/ml
Interval 132.6 to 448.1
|
264.4 mIU/ml
Interval 95.3 to 433.4
|
SECONDARY outcome
Timeframe: Within 7 days after the vaccinationOccurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine
Outcome measures
| Measure |
60 µg Dose Hepatitis B Vaccine
n=88 Participants
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 Dose Hepatitis B Vaccine
n=88 Participants
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
|
|---|---|---|
|
Occurrence of Adverse Events After Vaccination
pain
|
5 Participants
|
5 Participants
|
|
Occurrence of Adverse Events After Vaccination
erythema
|
6 Participants
|
5 Participants
|
|
Occurrence of Adverse Events After Vaccination
edema
|
5 Participants
|
4 Participants
|
|
Occurrence of Adverse Events After Vaccination
induration
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Within 28 days after vaccinationPopulation: Safety analysis was performed on all included participants.
Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine
Outcome measures
| Measure |
60 µg Dose Hepatitis B Vaccine
n=88 Participants
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 Dose Hepatitis B Vaccine
n=88 Participants
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
|
|---|---|---|
|
Occurrence of Adverse Events After Vaccination
fever
|
1 participants
|
1 participants
|
|
Occurrence of Adverse Events After Vaccination
headache
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Month 0-42Occurrence of Serious adverse events (SAE) within 42 month after vaccination with the hepatitis B
Outcome measures
| Measure |
60 µg Dose Hepatitis B Vaccine
n=88 Participants
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 Dose Hepatitis B Vaccine
n=88 Participants
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
|
|---|---|---|
|
Serious Adverse Events (SAE) Occurred During 42 Month
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 7The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.
Outcome measures
| Measure |
60 µg Dose Hepatitis B Vaccine
n=83 Participants
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 Dose Hepatitis B Vaccine
n=82 Participants
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
|
|---|---|---|
|
Number and Percentage of Participants With Anti-HBs High-level Response at Month 7
|
62 Participants
|
54 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.
Outcome measures
| Measure |
60 µg Dose Hepatitis B Vaccine
n=74 Participants
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 Dose Hepatitis B Vaccine
n=68 Participants
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
|
|---|---|---|
|
Number and Percentage of Participants With Anti-HBs High-level Response at Month 12
|
34 Participants
|
26 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6 before the third injectionPopulation: 83 and 70 patients in the IM60 and IM20 groups completed the followed-up at 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.
Outcome measures
| Measure |
60 µg Dose Hepatitis B Vaccine
n=83 Participants
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 Dose Hepatitis B Vaccine
n=80 Participants
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
|
|---|---|---|
|
Number and Percentage of Participants With Anti-HBs Antibodies at Month 6 Before the Third Injection
|
65 Participants
|
61 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6 before the third injectionAnti-HBs concentration at month 6 before the third injection as measured by CMIA（Chemiluminescent Microparticle Immunoassay）.
Outcome measures
| Measure |
60 µg Dose Hepatitis B Vaccine
n=83 Participants
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 Dose Hepatitis B Vaccine
n=80 Participants
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
|
|---|---|---|
|
Anti-HBs Concentration at Month 6 Before the Third Injection
|
148.9 mIU/ml
Interval 78.1 to 219.7
|
130.6 mIU/ml
Interval 72.5 to 188.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6 before the third injectionThe measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.
Outcome measures
| Measure |
60 µg Dose Hepatitis B Vaccine
n=83 Participants
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 Dose Hepatitis B Vaccine
n=80 Participants
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
|
|---|---|---|
|
Number and Percentage of Participants With Anti-HBs High-level Response at Month 6 Before the Third Injection
|
29 Participants
|
27 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 42The 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
| Measure |
60 µg Dose Hepatitis B Vaccine
n=60 Participants
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 Dose Hepatitis B Vaccine
n=65 Participants
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
|
|---|---|---|
|
Number and Percentage of Participants With Anti-HBs Seroconversion at Month 42
|
31 Participants
|
29 Participants
|
Adverse Events
60 µg Dose Hepatitis B Vaccine
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
20 µg Dose Hepatitis B Vaccine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
60 µg Dose Hepatitis B Vaccine
n=88 participants at risk
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 Dose Hepatitis B Vaccine
n=88 participants at risk
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
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain
|
5.7%
5/88
|
5.7%
5/88
|
|
Skin and subcutaneous tissue disorders
erythema
|
6.8%
6/88
|
5.7%
5/88
|
|
Skin and subcutaneous tissue disorders
edema
|
5.7%
5/88
|
4.5%
4/88
|
|
Skin and subcutaneous tissue disorders
induration
|
4.5%
4/88
|
4.5%
4/88
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place