Understanding why some people don't respond well to the Hepatitis B vaccine
Understanding Poor Vaccine Responses to Hepatitis B Vaccination
This study is testing a new version of the Hepatitis B vaccine to see if it helps adults who don’t respond well to the standard vaccine.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04674462 on ClinicalTrials.gov |
What this trial studies
This study investigates the immune responses to the Hepatitis B vaccine by comparing a traditional vaccine with a CpG-adjuvanted version that has shown better efficacy in preventing nonresponses. Researchers aim to understand the immunological mechanisms behind poor vaccine responses, which could lead to improved vaccine designs. The study will involve adult participants who meet specific eligibility criteria and will assess their immune responses to both vaccine types. The findings could provide valuable insights into vaccine development for various infectious diseases.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are willing to participate and do not have chronic HBV infection or other significant health issues.
Not a fit: Patients with known chronic HBV infection or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective vaccines that provide better protection against Hepatitis B and potentially other infections.
How similar studies have performed: Previous studies have indicated that CpG-adjuvanted vaccines may improve immune responses, suggesting a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. At least 18 years of age 2. Must be able to understand and sign the Informed Consent Form (ICF) Exclusion Criteria: 1. Known chronic HBV infection 2. Pregnancy 3. Known clinically significant anemia or contraindication to phlebotomy; i.e., anti-coagulation therapy or clinically significant thrombocytopenia 4. Any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study 5. Use of immune-suppressing medications in the 30 days prior to enrollment HIV/AIDS patients will be included in the study as these patients often have poor responses to HBV vaccine.
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ramin Herati, MD — NYU Langone Health
- Study coordinator: Ramin Herati, MD
- Email: Ramin.Herati@nyulangone.org
- Phone: 646-477-9086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.