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Vaccine

Adjuvanted vs Traditional Vaccines for Hepatitis B

Phase 4
Recruiting
Led By Ramin Herati, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age
Be older than 18 years old
Must not have
Known clinically significant anemia or contraindication to phlebotomy; i.e., anti-coagulation therapy or clinically significant thrombocytopenia
Known chronic HBV infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 1 post-final dose
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the traditional hepatitis B vaccine, which can cause nonresponses in some patients, to the CpG-adjuvanted HBV vaccine, which has far fewer rates of nonresponses.

Who is the study for?
This trial is for adults who can consent to participate and are generally healthy. It's not for those with chronic Hepatitis B, pregnant individuals, people with significant anemia or blood clotting issues, anyone on immune-suppressing drugs recently, or if the investigator thinks it's unsafe for them.
What is being tested?
The study compares two types of hepatitis B vaccines: the traditional one and a new CpG-adjuvanted vaccine designed to improve immune response. The goal is to understand why some people don't respond well to the current vaccine.
What are the potential side effects?
While specific side effects aren't listed here, typical reactions may include soreness at injection site, mild fever, fatigue or allergic responses. The adjuvant in the new vaccine could potentially cause different or more pronounced reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a serious form of anemia or a condition that makes drawing blood unsafe.
Select...
I have a long-term hepatitis B infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1 post-final dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 1 post-final dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Participants with Weak Vaccine Response

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CpG-adjuvanted HBV VaccineExperimental Treatment1 Intervention
Group II: Traditional HBV VaccineActive Control1 Intervention

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,415 Previous Clinical Trials
855,877 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,336 Previous Clinical Trials
5,392,634 Total Patients Enrolled
1 Trials studying Vaccine Reaction
10 Patients Enrolled for Vaccine Reaction
Ramin Herati, MDPrincipal InvestigatorNYU Langone Health

Media Library

CpG-adjuvanted HBV Vaccine (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04674462 — Phase 4
Vaccine Reaction Research Study Groups: CpG-adjuvanted HBV Vaccine, Traditional HBV Vaccine
Vaccine Reaction Clinical Trial 2023: CpG-adjuvanted HBV Vaccine Highlights & Side Effects. Trial Name: NCT04674462 — Phase 4
CpG-adjuvanted HBV Vaccine (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04674462 — Phase 4
~77 spots leftby Jul 2026
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