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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
Must not have
Chronic HCV infection
HBV seropositivity (e.g. HBsAb, HBcAb or HBeAb)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.
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.
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 below
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I have never had hepatitis B nor been vaccinated against it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have chronic hepatitis C.
Select...
I have tested positive for hepatitis B antibodies.
Select...
I am HIV positive.
Select...
I have a diagnosed bleeding disorder that needs special care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The Effects of HBV Vaccine on Memory B Cells
Secondary study objectives
B Cell Response to the HBV Vaccination

Side effects data

From 2007 Phase 3 trial • 1718 Patients • NCT00414050
28%
Injection-site erythema
26%
Irritability
20%
Injection-site swelling
17%
Injection-site pain
13%
Pyrexia
11%
Rhinitis
9%
Crying
6%
Diarrhoea
6%
Upper respiratory tract infection
4%
Injection-site induration
4%
Cough
3%
Conjunctivitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
RECOMBIVAX™ Hepatitis B Vaccine
Modified Process Hepatitis B Vaccine 5 µg (Micrograms)
Modified Process Hepatitis B Vaccine 10 µg
ENGERIX-B®

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

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
160 Previous Clinical Trials
16,514 Total Patients Enrolled
2 Trials studying Hepatitis B
47 Patients Enrolled for Hepatitis B
Weill Medical College of Cornell UniversityOTHER
1,087 Previous Clinical Trials
1,148,735 Total Patients Enrolled
2 Trials studying Hepatitis B
1,456 Patients Enrolled for Hepatitis B
Gabriel D. Victora, PhDPrincipal InvestigatorThe Rockefeller University

Media Library

Hepatitis B Vaccine (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05272735 — Phase 4
Hepatitis B Research Study Groups: Hepatitis B Vaccine (Recombinant)
Hepatitis B Clinical Trial 2023: Hepatitis B Vaccine Highlights & Side Effects. Trial Name: NCT05272735 — Phase 4
Hepatitis B Vaccine (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05272735 — Phase 4
~0 spots leftby Dec 2024
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