Understanding Poor Vaccine Responses to Hepatitis B Vaccination

Vaccine Reaction Clinical Trial

Official title:

Understanding Poor Vaccine Responses to Hepatitis B Vaccination

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04674462
• Other study ID #: 20-01782
• Status: Recruiting
• Phase: Phase 4
• Start date: July 7, 2022
• Est. completion date: July 2026

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Ramin Herati, MD
• Phone: 646-477-9086
• Email: Ramin.Herati[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis B
• Vaccine Reaction

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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