NCT04674462Active, not recruitingPhase 4
Understanding Poor Vaccine Responses to Hepatitis B Vaccination
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 101 (actual)
- First submitted
- 14 Dec 2020
- Start date
- 7 Jul 2022
- Primary completion date
- 9 Jun 2026
- Lead sponsor
- NYU Langone Health
- Diseases
- Hepatitis B
- NCT number
- NCT04674462
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 101
- From 7 Jul 2022 to the primary completion date, 9 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known clinically significant anemia or contraindication to phlebotomy; i.e., anti-coagulation therapy or clinically significant thrombocytopenia
- 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.
Other illness
- Known chronic HBV infection
- Any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study
Other
- Pregnancy
Who the study is looking for
- At least 18 years of age
- Must be able to understand and sign the Informed Consent Form (ICF)
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.