Status:
ACTIVE_NOT_RECRUITING
Understanding Poor Vaccine Responses to Hepatitis B Vaccination
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Vaccine Reaction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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....
Eligibility Criteria
Inclusion
- At least 18 years of age
- Must be able to understand and sign the Informed Consent Form (ICF)
Exclusion
- Known chronic HBV infection
- Pregnancy
- Known clinically significant anemia or contraindication to phlebotomy; i.e., anti-coagulation therapy or clinically significant thrombocytopenia
- Any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study
- 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.
Key Trial Info
Start Date :
July 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04674462
Start Date
July 7 2022
End Date
July 1 2026
Last Update
December 15 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016