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 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Vaccine Reaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CpG-adjuvanted HBV Vaccine

Biological

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 Vaccine

Biological

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.

Primary outcomes

Proportion of Participants with Weak Vaccine Response

Time frame: Month 1 Post-Final Dose

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)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2026
First posted: Dec 19, 2020
Registry last updated: Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting