Understanding Poor Vaccine Responses to Hepatitis B Vaccination

NCT04674462 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 20-01782
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Vaccine Reaction

Outcome Measures

Primary Outcomes (1)

• 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)

  Month 1 Post-Final Dose

Study Arms (2)

CpG-adjuvanted HBV Vaccine

EXPERIMENTAL

Biological: CpG-adjuvanted HBV Vaccine

Traditional HBV Vaccine

ACTIVE COMPARATOR

Biological: Traditional HBV Vaccine

Interventions

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.

CpG-adjuvanted HBV Vaccine

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.

Traditional HBV Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

• Ramin Herati, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: July 7, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to ramin.herati@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)