NCT04674462

Understanding Poor Vaccine Responses to Hepatitis B Vaccination

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	CpG-adjuvanted HBV Vaccine	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.
BIOLOGICAL	Traditional HBV Vaccine	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.

Timeline

• Start date: 2022-07-07
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2020-12-19
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study