Recombinant hepatitis B vaccine with CpG adjuvant for Healthcare Worker Hepatitis B Vaccine Nonresponder
Phase-Based Progress Estimates
Effectiveness
Safety
Healthcare Worker Hepatitis B Vaccine NonresponderRecombinant hepatitis B vaccine with CpG adjuvant - Biological
Study Summary
This trial is testing a new hepatitis B vaccine to see if it works better than the current one for people who didn't respond to the current one.
Eligible Conditions
- Healthcare Worker Hepatitis B Vaccine Nonresponder
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: one month after dose 2 (up to 84 days on study)
Day 42
Number of participants who respond to a single dose of hepB-CpG
Day 84
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
Proportion of participants who are nonresponders with each risk factor
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
1 Treatment Group
Healthcare worker
1 of 1
Experimental Treatment
130 Total Participants · 1 Treatment Group
Primary Treatment: Recombinant hepatitis B vaccine with CpG adjuvant · No Placebo Group · Phase 4
Healthcare worker
Biological
Experimental Group · 1 Intervention: Recombinant hepatitis B vaccine with CpG adjuvant · Intervention Types: BiologicalTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one month after dose 2 (up to 84 days on study)
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,070 Previous Clinical Trials
2,576,511 Total Patients Enrolled
Mary S Hayney, PharmD, MPHPrincipal InvestigatorUniversity of Wisconsin, Madison
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Wisconsin | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| University of Wisconsin | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
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Conditions
Cancer Related
Treatments