Understanding Poor Vaccine Responses to Hepatitis B Vaccination

Phase 4Active Not RecruitingNCT04674462

NYU Langone Health101 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

101

Conditions

Vaccine Reaction

Interventions

Subjects receiving CpG-adjuvanted HBV vaccine will require two doses at 0 and 1 month after initiation. The second dose will be considered the same as the one month time point following the first dose.

Traditional HBV VaccineBIOLOGICAL

Subjects receiving traditional HBV vaccine series will require three doses at 0, 1, and 6 months after initiation. The second dose will be considered the same as the one month time point following the first dose.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

Proportion of Participants with Weak Vaccine Response

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)

Time frame: Month 1 Post-Final Dose

Data from ClinicalTrials.gov

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