Your session is about to expire
← Back to Search
Vaccine
Hepatitis B Vaccine for Hepatitis B
Phase 4
Recruiting
Led By Gabriel D. Victora, PhD
Research Sponsored by Rockefeller University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No prior history of HBV infection or vaccination.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will look at how well the hepatitis B vaccine works in boosting immunity.
Who is the study for?
Healthy individuals aged 18-50, with no history of Hepatitis B infection or vaccination, can join this trial. They shouldn't have had severe reactions to vaccines before, any chronic infections like HCV, allergies to HBV vaccine components, immune disorders, or be on certain medications. Pregnant or breastfeeding individuals are excluded.Check my eligibility
What is being tested?
The study is testing the response of germinal centers in lymphoid organs to the Hepatitis B vaccine (Recombinant). It aims to understand how memory B cells react and adapt when boosted by vaccines—a key factor for improving vaccinations against mutating viruses.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of hepatitis B vaccination may include soreness at injection site, mild fever and fatigue. Severe allergic reactions are rare but possible.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never had hepatitis B nor been vaccinated against it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Effects of HBV Vaccine on Memory B Cells
Secondary outcome measures
B Cell Response to the HBV Vaccination
Side effects data
From 2007 Phase 3 trial • 1718 Patients • NCT0041405030%
Injection-site erythema
27%
Irritability
18%
Injection-site swelling
18%
Injection-site pain
14%
Pyrexia
12%
Rhinitis
10%
Crying
7%
Diarrhoea
7%
Upper respiratory tract infection
6%
Injection-site induration
5%
Cough
2%
Conjunctivitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Modified Process Hepatitis B Vaccine 5 µg (Micrograms)
RECOMBIVAX™ Hepatitis B Vaccine
Modified Process Hepatitis B Vaccine 10 µg
ENGERIX-B®
Trial Design
1Treatment groups
Experimental Treatment
Group I: Hepatitis B Vaccine (Recombinant)Experimental Treatment1 Intervention
Hepatitis B Vaccine (Recombinant) 20 mcg intramuscular injection at 0-1-6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hepatitis B Vaccine (Recombinant)
2006
Completed Phase 3
~1770
Find a Location
Who is running the clinical trial?
Rockefeller UniversityLead Sponsor
158 Previous Clinical Trials
16,345 Total Patients Enrolled
2 Trials studying Hepatitis B
47 Patients Enrolled for Hepatitis B
Weill Medical College of Cornell UniversityOTHER
1,055 Previous Clinical Trials
1,316,282 Total Patients Enrolled
2 Trials studying Hepatitis B
1,456 Patients Enrolled for Hepatitis B
Gabriel D. Victora, PhDPrincipal InvestigatorThe Rockefeller University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have chronic hepatitis C.I have tested positive for hepatitis B antibodies.I am between 18 and 50 years old.I have never had hepatitis B nor been vaccinated against it.I am either male or female.I am HIV positive.You have had serious reactions to vaccines in the past, such as difficulty breathing, severe allergic reactions, or severe skin problems at the injection site.I have a diagnosed bleeding disorder that needs special care.I haven't had any vaccines in the last 30 days and don't plan to get any in the next 30 days.I haven't used significant medications or had major health issues in the past 6 months.I do not have any health conditions that are getting worse or would make me unsuitable for the study.You have had an allergic reaction in the past to any parts of the HBV vaccine.
Research Study Groups:
This trial has the following groups:- Group 1: Hepatitis B Vaccine (Recombinant)
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.
Is the Recombinant Hepatitis B Vaccine innocuous for those taking it?
"The safety rating of the Recombinant Hepatitis b Vaccine is a 3, as there are multiple clinical studies that support its approval."
Answered by AI
Is the eligibility for this research restricted to people aged 85 and younger?
"According to the requirements of this medical trial, only individuals aged between 18 and 50 can be considered for enrollment. For those younger than 18 or older than 65 years old there are other options with a total of 158 clinical trials available for them specifically."
Answered by AI
What qualifications are necessary for individuals to be eligible for this clinical research?
"This trial seeks a cohort of 12 individuals between 18 and 50 years old suffering from hepatitis b. Notably, applicants must be male or female aged 18-50; those who are younger than 20 should have received the vaccine according to labels in the packaging insert. Moreover, people with prior history of HBV infection or vaccination cannot take part in this investigation."
Answered by AI
Are there any current openings to participate in this trial?
"The clinicaltrials.gov records show that, as of September 13th 2022, this research project is no longer recruiting participants. Having first been posted on December 1st 2022, the current status indicates a lack of enrolment opportunities; however there are still 177 other trials actively recruiting patients right now."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
The Rockefeller University
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Email
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger