Understanding Poor Vaccine Responses to Hepatitis B Vaccination

NYU Langone Health

Status and phase

Active, not recruiting

Phase 4

Conditions

Vaccine Reaction

Treatments

Biological: CpG-adjuvanted HBV Vaccine

Biological: Traditional HBV Vaccine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04674462

20-01782

Details and patient eligibility

About

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.

Enrollment

101 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

At least 18 years of age
Must be able to understand and sign the Informed Consent Form (ICF)

Exclusion criteria

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.