Understanding Poor Vaccine Responses to Hepatitis B Vaccination

Phase 4

Recruiting

• Conditions: Vaccine Reaction
• Interventions: Biological: CpG-adjuvanted HBV Vaccine; Biological: Traditional HBV Vaccine

• Registration Number: NCT04674462
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-19
• Study Start: 2022-07-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CpG-adjuvanted HBV Vaccine	CpG-adjuvanted HBV Vaccine	-
Traditional HBV Vaccine	Traditional HBV Vaccine	-

Primary Outcome Measures

Name	Time	Method
Proportion of Participants with Weak Vaccine Response	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)

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States