Trial Outcomes & Findings for A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults (NCT NCT02203357)

Results Overview

The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and \< 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but \< 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs antibody will be compared among the three vaccine groups.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

353 participants

Primary outcome timeframe

one month after a series vaccination of the regimen

Results posted on

2019-10-18

Participant Flow

Participant milestones

Participant milestones
Measure	20μg, 0-1-6 117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.	60μg, 0-1 111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.	60μg, 0-2 125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
Overall Study STARTED	117	111	125
Overall Study mon7/2/3	114	110	124
Overall Study mon12	113	101	122
Overall Study mon24	59	45	55
Overall Study COMPLETED	59	45	55
Overall Study NOT COMPLETED	58	66	70

Reasons for withdrawal

Reasons for withdrawal
Measure	20μg, 0-1-6 117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.	60μg, 0-1 111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.	60μg, 0-2 125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
Overall Study Lost to Follow-up	58	66	70

Baseline Characteristics

A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	20μg, 0-1-6 n=117 Participants 117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.	60μg, 0-1 n=111 Participants 111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.	60μg, 0-2 n=125 Participants 125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.	Total n=353 Participants Total of all reporting groups
Age, Continuous	20.32 years STANDARD_DEVIATION 1.13 • n=5 Participants	20.11 years STANDARD_DEVIATION 0.94 • n=7 Participants	20.18 years STANDARD_DEVIATION 1.07 • n=5 Participants	20.20 years STANDARD_DEVIATION 1.05 • n=4 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	32 Participants n=7 Participants	42 Participants n=5 Participants	114 Participants n=4 Participants
Sex: Female, Male Male	77 Participants n=5 Participants	79 Participants n=7 Participants	83 Participants n=5 Participants	239 Participants n=4 Participants
Region of Enrollment China	117 participants n=5 Participants	111 participants n=7 Participants	125 participants n=5 Participants	353 participants n=4 Participants

PRIMARY outcome

Timeframe: one month after a series vaccination of the regimen

The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and \< 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but \< 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs antibody will be compared among the three vaccine groups.

Outcome measures

Outcome measures
Measure	20μg, 0-1-6 n=117 Participants 117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.	60μg, 0-1 n=111 Participants 111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.	60μg, 0-2 n=125 Participants 125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults	1847.99 mIU/ml Interval 1417.75 to 2408.8	839.27 mIU/ml Interval 507.34 to 1388.35	1244.8 mIU/ml Interval 889.61 to 1742.21

SECONDARY outcome

Timeframe: 1-year after the first dose of the regimens

The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and \< 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but \< 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs will be compared among the three vaccine groups.

Outcome measures

Outcome measures
Measure	20μg, 0-1-6 n=113 Participants 117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.	60μg, 0-1 n=101 Participants 111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.	60μg, 0-2 n=122 Participants 125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults	1456.63 mIU/ml Interval 1102.78 to 1924.0	256.30 mIU/ml Interval 175.7 to 373.85	235.15 mIU/ml Interval 172.81 to 319.96

SECONDARY outcome

Timeframe: 2-year after the first dose of the regimens

The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and \< 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but \< 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs antibody will be compared among the three vaccine groups. The dynamic changes of seroprotection rates and GMCs of anti-HBs antibody will also be analyzed over the 2 years.

Outcome measures

Outcome measures
Measure	20μg, 0-1-6 n=59 Participants 117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.	60μg, 0-1 n=45 Participants 111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.	60μg, 0-2 n=55 Participants 125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults	427.46 mIU/ml Interval 274.92 to 664.51	89.74 mIU/ml Interval 50.43 to 159.7	89.80 mIU/ml Interval 56.96 to 141.58

OTHER_PRE_SPECIFIED outcome

Timeframe: 0-3 day after the first dose of immunization

Participants were monitored for any adverse events occurring within 30 min after each injection for immediate reactions and instructed to measure axillary temperature and record selected injection-site reactions (pain, erythema, induration, swelling, pruritus, cutaneous rash) and systemic reactions (headache, vomiting, asthenia, allergic reaction, fatigue, diarrhea, myalgia, general malaise, etc.) on the day of vaccination and the subsequent 3 days. Adverse reactions were graded or categorized according to the standard guideline for adverse reactions grading in vaccine clinical trials as Grade 1-3.

Outcome measures

Outcome measures
Measure	20μg, 0-1-6 n=117 Participants 117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.	60μg, 0-1 n=111 Participants 111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.	60μg, 0-2 n=125 Participants 125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
Safety of HBV Vaccine Determined by Number of Participants With Adverse Events	2 number of participants	2 number of participants	5 number of participants

Adverse Events

20μg, 0-1-6

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

60μg, 0-1

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

60μg, 0-2

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	20μg, 0-1-6 n=117 participants at risk 117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.	60μg, 0-1 n=111 participants at risk 111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.	60μg, 0-2 n=125 participants at risk 125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
Skin and subcutaneous tissue disorders injection site pain	1.7% 2/117 • Number of events 2	1.8% 2/111 • Number of events 2	4.0% 5/125 • Number of events 5

Additional Information

Dr. Hui Zhuang

Peking University Health Science Center

Phone: 86-10-82801617

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place