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Understanding Poor Vaccine Responses to Hepatitis B Vaccination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04674462
Recruitment Status : Recruiting
First Posted : December 19, 2020
Last Update Posted : July 12, 2022
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Vaccine Reaction Biological: CpG-adjuvanted HBV Vaccine Biological: Traditional HBV Vaccine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Understanding Poor Vaccine Responses to Hepatitis B Vaccination
Actual Study Start Date : July 7, 2022
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CpG-adjuvanted HBV Vaccine 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.

Active Comparator: Traditional HBV Vaccine 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.




Primary Outcome Measures :
  1. Proportion of Participants with Weak Vaccine Response [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04674462


Contacts
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Contact: Ramin Herati, MD 646-477-9086 Ramin.Herati@nyulangone.org
Contact: Vanessa Raabe, MD, MSc Vanessa.raabe@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Ramin Herati, MD       Ramin.Herati@nyulangone.org   
Contact: Vanessa Raabe, MD, MSc       Vanessa.Raab@nyulangone.org   
Principal Investigator: Ramin Herati, MD         
Sub-Investigator: Mark Mulligan, MD, FIDSA         
Sub-Investigator: Vanessa Raabe, MD, MSc         
Sponsors and Collaborators
NYU Langone Health
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Ramin Herati, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04674462    
Other Study ID Numbers: 20-01782
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: July 12, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Vaccines
Immunologic Factors
Physiological Effects of Drugs