Understanding Poor Vaccine Responses to Hepatitis B Vaccination

Last updated: January 28, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

4

Condition

Hepatitis B

Treatment

Traditional HBV Vaccine

CpG-adjuvanted HBV Vaccine

Clinical Study ID

NCT04674462
20-01782
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. At least 18 years of age

  2. Must be able to understand and sign the Informed Consent Form (ICF)

Exclusion

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 studyparticipation unsafe or would interfere with the objectives of the study

  5. Use of immune-suppressing medications in the 30 days prior to enrollment HIV/AIDSpatients will be included in the study as these patients often have poor responsesto HBV vaccine.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Traditional HBV Vaccine
Phase: 4
Study Start date:
July 07, 2022
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

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