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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 1 post-final dose
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants with Weak Vaccine Response

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
1,368 Previous Clinical Trials
839,526 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,269 Previous Clinical Trials
5,481,269 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

Frequently Asked Questions

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

Are we still enrolling individuals for this research project?

"Correct, according to the most recent information on clinicaltrials.gov, this trial is still looking for participants. The listing was first created on July 7th, 2022 and edited slightly the next day."

Answered by AI

What is the regulatory status of CpG-adjuvanted HBV Vaccine?

"CpG-adjuvanted HBV Vaccine is approved and, thus, safe."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~111 spots leftby Jul 2026