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Cancer Vaccine

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

Phase 4
Waitlist Available
Led By Mary S Hayney, PharmD, MPH
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month after dose 1 (up to 42 days on study)
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month after dose 2 (up to 84 days on study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and one month after dose 2 (up to 84 days on study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Number of participants who respond to a single dose of hepB-CpG
Proportion of participants who are nonresponders with each risk factor

Trial Design

1Treatment groups
Experimental Treatment
Group I: Healthcare workerExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Recombinant hepatitis B vaccine with CpG adjuvant
2020
Completed Phase 4
~50

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,176 Previous Clinical Trials
3,011,959 Total Patients Enrolled
Mary S Hayney, PharmD, MPHPrincipal InvestigatorUniversity of Wisconsin, Madison

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being accepted for this trial?

"Clinicaltrials.gov indicates that this trial is currently recruiting participants, the posting having initially been made on September 15th 2020 with a last update occurring on September 12th 2022."

Answered by AI

What is the maximum capacity for enrollees in this medical research?

"Affirmative. According to clinicaltrials.gov, this medical study is currently seeking participants; first posted September 15th 2020 and was last revised on September 12th 2022. 130 individuals need to be enrolled from a single trial site."

Answered by AI

Has the recombinant hepatitis B vaccine with CpG adjuvant earned FDA approval?

"The recombinant hepatitis b vaccine combined with CpG adjuvant has data indicating safety and efficacy, earning it a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
How old are they?
18 - 65
What site did they apply to?
University of Wisconsin
What portion of applicants met pre-screening criteria?
Did not meet criteria
~10 spots leftby Mar 2025