Understanding Poor Vaccine Responses to Hepatitis B Vaccination

Study Overview
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Brief Summary
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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.

Official Title
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Understanding Poor Vaccine Responses to Hepatitis B Vaccination

Conditions
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Vaccine Reaction

Intervention / Treatment
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* Biological: CpG-adjuvanted HBV Vaccine
* Biological: Traditional HBV Vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CpG-adjuvanted HBV Vaccine<br> | Biological: CpG-adjuvanted HBV Vaccine<br>* 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.<br>|
| Active Comparator: Traditional HBV Vaccine<br> | Biological: Traditional HBV Vaccine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |