Recombinant hepatitis B vaccine with CpG adjuvant for Healthcare Worker Hepatitis B Vaccine Nonresponder

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Healthcare Worker Hepatitis B Vaccine NonresponderRecombinant hepatitis B vaccine with CpG adjuvant - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

3 of 3
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

3 of 3
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: Biological

Trial 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

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Who else is applying?

What state do they live in?
Wisconsin100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Wisconsin100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%