Trial Outcomes & Findings for HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders (NCT NCT04456504)
NCT ID: NCT04456504
Last Updated: 2024-07-16
Results Overview
Response is defined as AntiHBs \>10 mIU/ml following two doses of hepB-CpG
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
49 participants
Primary outcome timeframe
one month after dose 2 (up to 84 days on study)
Results posted on
2024-07-16
Participant Flow
Participants were enrolled from September 2020 to September 2023.
Participant milestones
| Measure |
Healthcare Worker
Healthcare worker who has previously received at least 5 doses of hepatitis B vaccine with aluminum adjuvant (Recombivax B or Engerix B) and has an antibody to the hepatitis B surface antigen (antiHBs) that is less than 10 mIU/ml.
Recombinant hepatitis B vaccine with CpG adjuvant: Each participant will receive two doses of hepB-CpG separated by one month and blood draw to measure antibody to the hepatitis B surface antigen prior to dose 2 and one month after dose 2.
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|---|---|
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Overall Study
STARTED
|
49
|
|
Overall Study
Number of Participants Who Received First Dose
|
49
|
|
Overall Study
Number of Participants Who Had Blood Draw After First Dose
|
49
|
|
Overall Study
Number of Participants Who Received Second Dose
|
48
|
|
Overall Study
Number of Participants Who Had Blood Draw After Second Dose
|
47
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Healthcare Worker
Healthcare worker who has previously received at least 5 doses of hepatitis B vaccine with aluminum adjuvant (Recombivax B or Engerix B) and has an antibody to the hepatitis B surface antigen (antiHBs) that is less than 10 mIU/ml.
Recombinant hepatitis B vaccine with CpG adjuvant: Each participant will receive two doses of hepB-CpG separated by one month and blood draw to measure antibody to the hepatitis B surface antigen prior to dose 2 and one month after dose 2.
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|---|---|
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Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders
Baseline characteristics by cohort
| Measure |
Healthcare Worker
n=49 Participants
Healthcare worker who has previously received at least 5 doses of hepatitis B vaccine with aluminum adjuvant (Recombivax B or Engerix B) and has an antibody to the hepatitis B surface antigen (antiHBs) that is less than 10 mIU/ml.
Recombinant hepatitis B vaccine with CpG adjuvant: Each participant will receive two doses of hepB-CpG separated by one month and blood draw to measure antibody to the hepatitis B surface antigen prior to dose 2 and one month after dose 2.
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|---|---|
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Age, Customized
18-39 years old
|
28 Participants
n=5 Participants
|
|
Age, Customized
40-59 years old
|
16 Participants
n=5 Participants
|
|
Age, Customized
equal to or greater than 60 years old
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic / Latinx
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black / African American
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian / Alaska Native
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
|
Number of Prior Vaccine Doses
5
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2 Participants
n=5 Participants
|
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Number of Prior Vaccine Doses
6
|
44 Participants
n=5 Participants
|
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Number of Prior Vaccine Doses
9
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3 Participants
n=5 Participants
|
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Smoking Status
Current Smoker
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3 Participants
n=5 Participants
|
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Smoking Status
Non-Smoker
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39 Participants
n=5 Participants
|
|
Smoking Status
Former Smoker
|
7 Participants
n=5 Participants
|
|
Immunocompromised
Yes
|
6 Participants
n=5 Participants
|
|
Immunocompromised
No
|
42 Participants
n=5 Participants
|
|
Immunocompromised
Missing Data
|
1 Participants
n=5 Participants
|
|
Diabetes
Yes
|
4 Participants
n=5 Participants
|
|
Diabetes
No
|
45 Participants
n=5 Participants
|
|
Any Risk Factor
Yes
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31 Participants
n=5 Participants
|
|
Any Risk Factor
No
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18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one month after dose 2 (up to 84 days on study)Population: 1 participant dropped out of the study prior to the second dose, and 1 participant dropped out of the study prior to data collection post-second dose
Response is defined as AntiHBs \>10 mIU/ml following two doses of hepB-CpG
Outcome measures
| Measure |
Healthcare Worker
n=47 Participants
Healthcare worker who has previously received at least 5 doses of hepatitis B vaccine with aluminum adjuvant (Recombivax B or Engerix B) and has an antibody to the hepatitis B surface antigen (antiHBs) that is less than 10 mIU/ml.
Recombinant hepatitis B vaccine with CpG adjuvant: Each participant will receive two doses of hepB-CpG separated by one month and blood draw to measure antibody to the hepatitis B surface antigen prior to dose 2 and one month after dose 2.
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|---|---|
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Number of Participants Who Failed to Respond to 5 or More Doses of Hepatitis B Vaccine With Aluminum Adjuvant Who Respond to Hepatitis B Vaccine With CpG Adjuvant Series
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43 Participants
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SECONDARY outcome
Timeframe: one month after dose 1 (up to 42 days on study)Response is defined as AntiHBs \>10 mIU/ml following a single dose of hepB-CpG
Outcome measures
| Measure |
Healthcare Worker
n=49 Participants
Healthcare worker who has previously received at least 5 doses of hepatitis B vaccine with aluminum adjuvant (Recombivax B or Engerix B) and has an antibody to the hepatitis B surface antigen (antiHBs) that is less than 10 mIU/ml.
Recombinant hepatitis B vaccine with CpG adjuvant: Each participant will receive two doses of hepB-CpG separated by one month and blood draw to measure antibody to the hepatitis B surface antigen prior to dose 2 and one month after dose 2.
|
|---|---|
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Number of Participants Who Respond to a Single Dose of hepB-CpG
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41 Participants
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SECONDARY outcome
Timeframe: one month after dose 2 (up to 84 days on study)Population: Number of non-responders
A multivariate model will be developed by measuring the proportion of participants who are nonresponders with each risk factor. Potential risk factors include including age, smoking status, sex, diabetes, immunosuppression.
Outcome measures
| Measure |
Healthcare Worker
n=4 Participants
Healthcare worker who has previously received at least 5 doses of hepatitis B vaccine with aluminum adjuvant (Recombivax B or Engerix B) and has an antibody to the hepatitis B surface antigen (antiHBs) that is less than 10 mIU/ml.
Recombinant hepatitis B vaccine with CpG adjuvant: Each participant will receive two doses of hepB-CpG separated by one month and blood draw to measure antibody to the hepatitis B surface antigen prior to dose 2 and one month after dose 2.
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|---|---|
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Proportion of Participants Who Are Nonresponders With Each Risk Factor
Male
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0 Participants
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Proportion of Participants Who Are Nonresponders With Each Risk Factor
Equal to or greater than 60 years old
|
3 Participants
|
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Proportion of Participants Who Are Nonresponders With Each Risk Factor
Current Smoker
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0 Participants
|
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Proportion of Participants Who Are Nonresponders With Each Risk Factor
Immunocomprised
|
1 Participants
|
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Proportion of Participants Who Are Nonresponders With Each Risk Factor
Diabetes
|
0 Participants
|
Adverse Events
Healthcare Worker - Dose 1
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Healthcare Worker - Dose 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
| Measure |
Healthcare Worker - Dose 1
n=49 participants at risk
Healthcare worker who has previously received at least 5 doses of hepatitis B vaccine with aluminum adjuvant (Recombivax B or Engerix B) and has an antibody to the hepatitis B surface antigen (antiHBs) that is less than 10 mIU/ml.
Recombinant hepatitis B vaccine with CpG adjuvant: Each participant will receive two doses of hepB-CpG separated by one month and blood draw to measure antibody to the hepatitis B surface antigen prior to dose 2 and one month after dose 2.
|
Healthcare Worker - Dose 2
n=47 participants at risk
Healthcare worker who has previously received at least 5 doses of hepatitis B vaccine with aluminum adjuvant (Recombivax B or Engerix B) and has an antibody to the hepatitis B surface antigen (antiHBs) that is less than 10 mIU/ml.
Recombinant hepatitis B vaccine with CpG adjuvant: Each participant will receive two doses of hepB-CpG separated by one month and blood draw to measure antibody to the hepatitis B surface antigen prior to dose 2 and one month after dose 2.
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|---|---|---|
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Injury, poisoning and procedural complications
Injection site soreness
|
36.7%
18/49 • Adverse events data collected while participants are on study, up to 12 weeks
Adverse Events are reported per dose, 49 participants for the first dose, and 47 of the 49 for the second dose as 2 participants were lost to follow up.
|
10.6%
5/47 • Adverse events data collected while participants are on study, up to 12 weeks
Adverse Events are reported per dose, 49 participants for the first dose, and 47 of the 49 for the second dose as 2 participants were lost to follow up.
|
|
General disorders
Chills
|
2.0%
1/49 • Adverse events data collected while participants are on study, up to 12 weeks
Adverse Events are reported per dose, 49 participants for the first dose, and 47 of the 49 for the second dose as 2 participants were lost to follow up.
|
0.00%
0/47 • Adverse events data collected while participants are on study, up to 12 weeks
Adverse Events are reported per dose, 49 participants for the first dose, and 47 of the 49 for the second dose as 2 participants were lost to follow up.
|
|
General disorders
Headache
|
2.0%
1/49 • Adverse events data collected while participants are on study, up to 12 weeks
Adverse Events are reported per dose, 49 participants for the first dose, and 47 of the 49 for the second dose as 2 participants were lost to follow up.
|
0.00%
0/47 • Adverse events data collected while participants are on study, up to 12 weeks
Adverse Events are reported per dose, 49 participants for the first dose, and 47 of the 49 for the second dose as 2 participants were lost to follow up.
|
|
General disorders
Fatigue
|
2.0%
1/49 • Adverse events data collected while participants are on study, up to 12 weeks
Adverse Events are reported per dose, 49 participants for the first dose, and 47 of the 49 for the second dose as 2 participants were lost to follow up.
|
0.00%
0/47 • Adverse events data collected while participants are on study, up to 12 weeks
Adverse Events are reported per dose, 49 participants for the first dose, and 47 of the 49 for the second dose as 2 participants were lost to follow up.
|
Additional Information
Mary Hayney, PharmD, MPH, FCCP, BCPS
University of Wisconsin School of Pharmacy
Phone: 608-265-4666
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place