Adjuvanted vs Traditional Vaccines for Hepatitis B
Recruiting in Palo Alto (17 mi)
Overseen byRamin Herati, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: NYU Langone Health
Must not be taking: Immune-suppressing medications
Disqualifiers: Chronic HBV, Pregnancy, Anemia, others
Stay on Your Current Meds
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?Vaccines have prevented countless infections but poor vaccine responses remain a major challenge in many scenarios. Hepatitis B vaccine nonresponses are common but immunologically not well-understood.
This study aims to study the immunology of hepatitis B vaccine responses by comparing traditional HBV vaccine, which is associated with nonresponses in some patients, to CpG-adjuvanted HBV vaccine, which is associated with far fewer rates of nonresponses. This research will build upon prior studies of the human immune response to infection to gain a deeper understanding of the complexity of these responses. This information will be broadly useful as many vaccine candidates fail due to lack of immunogenicity, potentially enabling improved vaccine design and better protection.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used immune-suppressing medications in the 30 days before joining.
What data supports the effectiveness of the treatment Heplisav-B for Hepatitis B?
Heplisav-B, a hepatitis B vaccine with a novel adjuvant, has shown superior effectiveness compared to traditional vaccines like Engerix-B. In studies, 90-100% of people who received Heplisav-B developed protective antibodies, compared to 71-90% with Engerix-B, especially benefiting those who typically respond poorly to vaccines, such as older adults and people with chronic conditions.
12345Is the CpG-adjuvanted Hepatitis B vaccine safe for humans?
The CpG-adjuvanted Hepatitis B vaccine, known as HEPLISAV-B, has been shown to have a similar safety profile to traditional vaccines like Engerix-B in studies involving thousands of participants. It has been evaluated for safety in both clinical trials and post-marketing studies, with no significant increase in adverse events compared to traditional vaccines.
12356How does the CpG-adjuvanted HBV vaccine differ from traditional hepatitis B vaccines?
The CpG-adjuvanted HBV vaccine (Heplisav-B) is unique because it uses a novel adjuvant that stimulates the immune system more effectively, requires only two doses over one month, and provides higher protection rates, especially in people who typically respond poorly to vaccines, compared to traditional three-dose vaccines like Engerix-B.
12345Eligibility Criteria
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.Inclusion Criteria
Must be able to understand and sign the Informed Consent Form (ICF)
I am 18 years old or older.
Exclusion Criteria
Pregnancy
I haven't taken immune-suppressing drugs in the last 30 days.
Any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either the traditional HBV vaccine or the CpG-adjuvanted HBV vaccine
4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (in-person) at Month 1 post-final dose
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: CpG-adjuvanted HBV VaccineExperimental Treatment1 Intervention
Group II: Traditional HBV VaccineActive Control1 Intervention
CpG-adjuvanted HBV Vaccine is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as HEPLISAV-B for:
- Prevention of hepatitis B infection in adults 18 years of age and older
🇪🇺 Approved in European Union as CpG-adjuvanted Hepatitis B Vaccine for:
- Prevention of hepatitis B infection in adults
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NYU Langone HealthNew York, NY
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)Collaborator
References
Post-licensure safety study of new-onset immune-mediated diseases, herpes zoster, and anaphylaxis in adult recipients of HepB-CpG vaccine versus HepB-alum vaccine. [2023]HepB-CpG (Heplisav-B) is a licensed hepatitis B vaccine with a novel adjuvant that requires 2 doses (0, 1 month) compared to HepB-alum (Engerix-B) which requires 3 doses (0, 1, 6 months). Monitoring safety outcomes following receipt of vaccines with novel adjuvants outside trial settings is important. Hence, as part of a post-marketing commitment, we compared the incidence of new-onset immune-mediated diseases, herpes zoster (HZ), and anaphylaxis among recipients of HepB-CpG versus HepB-alum.
Observational Study Evaluating the Seroprotection of HepB-alum Vaccine and HepB-CpG Vaccine in People With HIV. [2023]Hepatitis B virus (HBV) vaccine seroprotection rates with conventional aluminum adjuvanted recombinant HBV vaccines, Engerix-B (HepB-alum) vaccine, among people with HIV (PWH) are varied. Heplisav-B (HepB-CpG) vaccine, a novel adjuvanted recombinant HBV vaccine, has shown higher seroprotection rates in immunocompetent patients but is not well studied in PWH. There are no published studies comparing seroprotection rates between HepB-alum and HepB-CpG in PWH. This study aims to evaluate and compare the seroprotection incidence of HepB-alum vs HepB-CpG in PWH at least 18 years of age.
CpG-Adjuvanted Hepatitis B Vaccine (HEPLISAV-B®) Update. [2022]Introduction: HEPLISAV-B is a hepatitis B vaccine composed of rHBsAg mixed with a synthetic oligonucleotide containing CpG motifs that stimulate innate immunity through TLR9. This vaccine was recently approved by FDA in view of its superior efficacy.Areas covered: Published literature on HEPLISAV-B was critically reviewed. Four randomized controlled trials among 7,056 subjects receiving 2 doses of HEPLISAV-B and 3,214 subjects receiving 3 doses of Engerix-B showed superior seroprotection rate (SPR) (anti-HBs ≥10 mIU/mL) of 90-100%, compared with 71-90% in those receiving Engerix-B. Furthermore, the seroprotection rate was also significantly higher in HEPLISAV-B compared with Engerix-B recipients in persons with traditionally poor vaccine responses such as older adults, diabetics, and those with chronic kidney disease. The safety profiles among 9,871 subjects were similar between HEPLISAV-B and Engerix-B .Expert opinion: HEPLISAV-B, a CpG adjuvant mixed with HBsAg, is more efficacious and produced earlier seroprotection compared to existing vaccines, with a favorable safety profile. The shorter, two-dose regimen, earlier seroprotection, higher adherence, and a higher seroprotection rate, especially in populations with traditionally poor vaccine response, makes this an important therapeutic option in hepatitis B vaccination.
Association Between 2-Dose vs 3-Dose Hepatitis B Vaccine and Acute Myocardial Infarction. [2022]The 2-dose hepatitis B vaccine with a cytosine phosphoguanine adjuvant (HepB-CpG vaccine; Heplisav-B) generated higher seroprotection in prelicensure trials than did a 3-dose hepatitis B vaccine with an aluminum hydroxide adjuvant (HepB-alum vaccine; Engerix-B). However, in 1 trial, a higher number of acute myocardial infarction (MI) events were observed among those who received the HepB-CpG vaccine than among those who received the HepB-alum vaccine, an outcome requiring further study.
Recommendations of the Advisory Committee on Immunization Practices for Use of a Hepatitis B Vaccine with a Novel Adjuvant. [2019]Hepatitis B (HepB) vaccination is the primary means of preventing infections and complications caused by hepatitis B virus (HBV). On February 21, 2018, the Advisory Committee on Immunization Practices (ACIP) recommended Heplisav-B (HepB-CpG), a yeast-derived vaccine prepared with a novel adjuvant, administered as a 2-dose series (0, 1 month) for use in persons aged ≥18 years. The ACIP Hepatitis Vaccines Work Group conducted a systematic review of the evidence, including data from four randomized controlled trials assessing prevention of HBV infection and six randomized controlled trials assessing adverse events in adults. Seroprotective antibody to hepatitis B surface antigen (anti-HBs) levels were achieved in 90.0%-100.0% of subjects receiving HepB-CpG (Dynavax Technologies Corporation), compared with 70.5%-90.2% of subjects receiving Engerix-B (GlaxoSmithKline Biologicals). The benefits of protection with 2 doses administered over 1 month make HepB-CpG an important option for prevention of HBV.
Heplisav-B: A Hepatitis B Vaccine With a Novel Adjuvant. [2021]To review the immunogenicity and safety of a hepatitis B vaccine containing the cytosine phosphoguanosine (CpG) 1018 adjuvant (HepB-CpG).