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NCT04674462 · ClinicalTrials.gov registry record · Phase 4
Understanding Poor Vaccine Responses to Hepatitis B Vaccination
A Phase 4 study of Vaccine Reaction, sponsored by NYU Langone Health.
- Active
- Registry status
- Phase 4
- Development phase
- 101
- Enrollment target
- 1
- Study location
NCT04674462: Active Phase 4 study of Vaccine Reaction, sponsored by NYU Langone Health.
NCT04674462 is a Phase 4 study of Vaccine Reaction that is active but no longer recruiting, run by NYU Langone Health. The registered enrollment target is 101 participants, below the 118-participant average among 4 other Vaccine Reaction trials with a reported enrollment target (14% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04674462, a Phase 4 study of Vaccine Reaction, is active but no longer recruiting, sponsored by NYU Langone Health.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 101 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Weak vaccine response is defined as Hepatitis B surface antigen antibodies \<= 10 mIU/mL (i.e. plasma anti-Hepatitis B surface antibody titer that is undetectable or below the cuff)
Conditions Studied
Interventions
- BIOLOGICAL CpG-adjuvanted HBV Vaccine
- BIOLOGICAL Traditional HBV Vaccine
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2022-07-07 |
| Est. Completion | 2026-07 |
| Phase | Phase 4 |
What the registry record for NCT04674462 still lists
NCT04674462 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 118-participant average among 4 other Vaccine Reaction trials with a reported enrollment target (14% lower).
The record links to 1 condition, with Vaccine Reaction appearing as the primary indexed condition, and to 2 interventions - of which CpG-adjuvanted HBV Vaccine is the first listed.
NCT04674462 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04674462 about?
NCT04674462 is a clinical study titled "Understanding Poor Vaccine Responses to Hepatitis B Vaccination". 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 ...
What is the current status of trial NCT04674462?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 101 participants. The study started on 2022-07-07. Estimated completion is 2026-07.
What conditions does trial NCT04674462 study?
This clinical trial studies the following conditions: Vaccine Reaction.
What interventions are being tested in trial NCT04674462?
The interventions under investigation include: CpG-adjuvanted HBV Vaccine (BIOLOGICAL), Traditional HBV Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04674462?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04674462 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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