Hepatitis B Vaccine for Hepatitis B

Overseen By Recruitment Specialist

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Rockefeller University

Must not be taking: Systemic corticosteroids, Immunosuppressive, Anticancer, others

Disqualifiers: HIV, Chronic HCV, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 months

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the hepatitis B vaccine's effects by studying specific immune cells called B cells, focusing on their response to booster doses. Researchers seek to determine if these memory B cells can adapt to new virus strains, potentially improving vaccines for other viruses like influenza and HIV. Participants will receive the hepatitis B vaccine and provide samples for analysis. Suitable candidates have never had hepatitis B, have not been vaccinated against it, and do not have major health issues or allergies to the vaccine. As a Phase 4 trial, the hepatitis B vaccine is already FDA-approved and proven effective, and this research helps understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have used certain medications like systemic corticosteroids, immunosuppressive, anticancer, or antituberculosis drugs in the past 6 months. It's best to discuss your specific medications with the trial team.

What is the safety track record for the Hepatitis B Vaccine?

Research has shown that the hepatitis B vaccine is generally safe and easy to handle. Common side effects are mild and may include pain, soreness, or redness at the injection site, as well as headache and tiredness. These effects typically last only a day or two. Past studies reported no serious reactions linked to the vaccine. This indicates that while some mild discomfort is normal, serious issues are rare. Overall, the vaccine is considered safe for most people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard hepatitis B vaccines, which often use inactivated virus particles or plasma-derived components, the Hepatitis B Vaccine (Recombinant) is engineered using recombinant DNA technology. This method allows for the production of a vaccine that is highly purified and consistent, potentially improving its safety and reducing side effects compared to traditional options. Researchers are excited about this treatment because it could offer a more stable and reliable immune response, making it a promising candidate for more effective prevention of hepatitis B infection.

What is the effectiveness track record for the Hepatitis B vaccine?

Research has shown that the hepatitis B vaccine, which participants in this trial will receive, effectively prevents the virus. Studies have found that it generates a strong immune response in most people, with over 90% developing protective antibodies after completing the vaccine series. This vaccine has been used for many years and is part of the regular vaccination schedule in many countries due to its effectiveness. Additionally, the vaccine is generally safe, with few side effects reported. Its success in preventing hepatitis B has made it a model for developing vaccines for other challenging viruses. ^{3 6 7 8 9}

Who Is on the Research Team?

Gabriel D. Victora, PhD

Principal Investigator

The Rockefeller University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am either male or female.

Exclusion Criteria

I have chronic hepatitis C.

I have tested positive for hepatitis B antibodies.

I am HIV positive.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Hepatitis B Vaccine (Recombinant) 20 mcg intramuscular injection at 0-1-6 months

6 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the third dose of the HBV vaccine

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hepatitis B Vaccine

Trial Overview 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.

How Is the Trial Designed?

Group I: Hepatitis B Vaccine (Recombinant) Experimental Treatment 1 Intervention

Hepatitis B Vaccine (Recombinant) 20 mcg intramuscular injection at 0-1-6 months

Hepatitis B Vaccine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Engerix-B for:

• Prevention of infection caused by all known subtypes of hepatitis B virus

Approved in United States as Heplisav-B for:

• Prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older

Approved in United States as Recombivax HB for:

• Prevention of infection caused by all known subtypes of hepatitis B virus

Approved in United States as Twinrix for:

• Prevention of infection caused by hepatitis A and hepatitis B viruses

Approved in European Union as Engerix-B for:

• Prevention of infection caused by all known subtypes of hepatitis B virus

Approved in European Union as Heplisav-B for:

• Prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older

Approved in European Union as Prehevbrio for:

• Prevention of infection caused by all known subtypes of hepatitis B virus

Approved in Canada as Engerix-B for:

• Prevention of infection caused by all known subtypes of hepatitis B virus

Who Is Running the Clinical Trial?

Rockefeller University

Lead Sponsor

Trials

162

Recruited

16,700+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

Both the Euvax-B and Engerix-B hepatitis B vaccines were found to be well tolerated and highly effective, with seroprotection rates exceeding 90% in all groups of 300 newborns studied.

Euvax-B was shown to be clinically identical to Engerix-B, meaning it can be safely used interchangeably in a vaccination schedule, allowing flexibility in immunizing infants against hepatitis B.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of two recombinant hepatitis B vaccines and their interchangeability in Argentine infants. Tregnaghi, M., Ussher, J., Baudagna, AM., et al.[2019]

In a study of 64 people with HIV who received the Heplisav-B vaccine, the seroprotection rate (SPR) was 81%, indicating that the vaccine is effective in providing protection against hepatitis B in this population.

The SPR was particularly high (86%) in individuals without significant non-HIV immunosuppression, suggesting that Heplisav-B could be a viable option for HBV vaccination in people with HIV, especially those with better immune function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: Heplisav-B Seroprotection in People With HIV: A Single-Center Experience. Schnittman, SR., Zepf, R., Cocohoba, J., et al.[2022]

A clinical trial involving 400 healthy adults demonstrated that four hepatitis B vaccines, including Heberbiovac-HB, Euvax-B, Hepavax-Gene, and Engerix-B, were safe and highly immunogenic, achieving similar seroprotection rates of around 96-100% after the second and third doses.

Heberbiovac-HB showed significantly higher antibody levels and responder rates compared to the other vaccines, indicating it may provide a stronger immune response, although all vaccines were well tolerated with no serious adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of four recombinant hepatitis B vaccines applied on an accelerated schedule in healthy adults. Hernández-Bernal, F., Aguilar-Betancourt, A., Aljovin, V., et al.[2011]

HEPLISAV-B, a new hepatitis B vaccine, demonstrated a superior seroprotection rate of 90-100% in 7,056 subjects compared to 71-90% for the traditional Engerix-B vaccine, particularly benefiting populations with poor vaccine responses like older adults and diabetics.

The safety profile of HEPLISAV-B was comparable to Engerix-B across 9,871 subjects, making it a promising option due to its higher efficacy, shorter two-dose regimen, and earlier seroprotection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CpG-Adjuvanted Hepatitis B Vaccine (HEPLISAV-B®) Update. Lee, GH., Lim, SG.[2022]

HEPLISAV™ provides higher and earlier seroprotection rates (89-96%) compared to Engerix-B (62-81%) with fewer doses required, making it a more efficient vaccination option for preventing hepatitis B infection in various populations.

The cost-effectiveness analysis showed that HEPLISAV is economically favorable, with incremental cost-effectiveness ratios under $25,000 for all studied groups, and it was even cost-saving for patients with chronic or end-stage kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of hepatitis B vaccination using HEPLISAV™ in selected adult populations compared to Engerix-B® vaccine. Kuan, RK., Janssen, R., Heyward, W., et al.[2022]

Engerix-B is a safe and well-tolerated recombinant DNA vaccine that effectively immunizes against all known subtypes of the hepatitis B virus.

The vaccine produces anti-HBs antibody responses that are comparable to those generated by traditional plasma-derived hepatitis B vaccines, indicating its efficacy in providing immunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engerix-B hepatitis B vaccine (recombinant)/Smith, Kline & French. Swartz, ML.[2007]

The new recombinant hepatitis B vaccine (Bio-Hep-B) at a reduced dose of 2.5 micrograms was found to be as safe as the standard 10 microgram dose of the licensed vaccine (Engerix-B) in a study involving 217 children aged 4-9 years.

While Bio-Hep-B showed a trend towards better immunogenicity at early time points, both vaccines produced similar antibody responses, indicating that the lower dose of Bio-Hep-B is effective for immunization against hepatitis B.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a novel mammalian cell-derived recombinant hepatitis B vaccine containing Pre-S1 and Pre-S2 antigens in children. Raz, R., Dagan, R., Gallil, A., et al.[2019]

In a study involving 105 healthy infants, both the new recombinant hepatitis B vaccine (Hepavax-Gene) and the standard Engerix-B vaccine demonstrated over 94% effectiveness in providing seroprotection against hepatitis B within 360 days.

The safety profiles of both vaccines were comparable, with no serious adverse events reported, and very few subjects remained HBsAg positive after 2 years, indicating strong long-term protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy, safety and immunogenicity of Hepavax-Gene and Engerix-B, recombinant hepatitis B vaccines, in infants born to HBsAg and HBeAg positive mothers in Vietnam: an assessment at 2 years. Hieu, NT., Kim, KH., Janowicz, Z., et al.[2019]

In a study involving healthcare workers who did not respond to the Engerix B® vaccine, the Fendrix® adjuvanted vaccine demonstrated a 92.3% success rate in developing humoral immunity against Hepatitis B after a specific vaccination schedule.

The Fendrix® vaccine showed a significant increase in antibody levels after the initial doses, suggesting it could be a viable alternative for immunizing healthcare workers against HBV who are nonresponsive to traditional vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fendrix® Vaccine Effectiveness in Healthcare Workers Who Are Non-Responsive to Engerix B® Vaccination. Tejada-Pérez, JJ., Vázquez-Vicente, JJ., Herrera-Burgos, MR., et al.[2021]

Citations

1. immunize.org immunize.org/ask-experts/topic/hepb/vaccine-recommendations-hepb/

Ask the Experts: Hepatitis B: Vaccine Recommendations Read answers by medical experts to healthcare provider questions on vaccines and Hepatitis B | Vaccine Recommendations.

2. cdc.gov cdc.gov/vaccine-safety/vaccines/hepatitis-b.html

Hepatitis B Vaccine Safety Many people who get a hepatitis B vaccine have no side effects at all. The most common side effects include injection site pain, soreness, or redness, headache ...

3. mayoclinic.org mayoclinic.org/drugs-supplements/hepatitis-a-and-hepatitis-b-vaccine-intramuscular-route/description/drg-20061965

Hepatitis a and hepatitis b vaccine (intramuscular route) Hepatitis A and hepatitis B combination vaccine is used to prevent infection caused by all known subtypes of the hepatitis A and hepatitis B virus.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11053833/

Hepatitis B Vaccine: Four Decades on - PMC - PubMed Central A safe and effective vaccine has been available since 1980, yet prevalence of chronic HBV infection has not declined substantially. Universal vaccination ...

5. hepb.org hepb.org/prevention-and-diagnosis/vaccination/guidelines-2/

Hepatitis B Vaccine Schedules Data released by Dynavax has increased response rates to Heplisav-B compared to traditional three-dose vaccine brands (Engerix-B, Recombivax HB, and Twinrix) in ...

6. merckvaccines.com merckvaccines.com/recombivax-hb/

RECOMBIVAX HB ® [Hepatitis B Vaccine (Recombinant)] The following adverse reactions were reported (≥1% of injections) injection site reactions, fatigue/weakness, headache, fever, malaise, nausea, diarrhea, ...

7. webmd.com webmd.com/drugs/2/drug-148035/hepatitis-b-virus-vaccine-recomb-pf-intramuscular/details

Hepatitis B Vaccine (Engerix-B, Heplisav-B, Recombivax HB) Common side effects include pain and soreness near the injection site, fever, headache, tiredness, weakness, irritability, diarrhea, loss of ...

8. fda.gov fda.gov/files/vaccines%2C%20blood%20&%20biologics/published/package-insert-recombivax-hb.pdf

Package Insert - Recombivax HB No serious vaccine-related adverse events were reported, and no impairment of immune response to these individually tested vaccine antigens was demonstrated.

9. mayoclinic.org mayoclinic.org/drugs-supplements/hepatitis-b-vaccine-intramuscular-route/description/drg-20068700

Hepatitis b vaccine (intramuscular route) - Side effects & uses Bleeding problems (e.g., hemophilia)—Use with caution. May have an increased risk of bleeding at the injection site. Multiple sclerosis—Use with ...