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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 belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 1 post-final dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1 post-final dose
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken immune-suppressing drugs in the last 30 days.I have a serious form of anemia or a condition that makes drawing blood unsafe.I have a long-term hepatitis B infection.I am 18 years old or older.I am HIV positive and have had a poor response to the HBV vaccine.
Research Study Groups:
This trial has the following groups:- Group 1: CpG-adjuvanted HBV Vaccine
- Group 2: Traditional HBV Vaccine
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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