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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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)
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
|Contact: Ramin Herati, MD||646-477-9086||Ramin.Herati@nyulangone.org|
|Contact: Vanessa Raabe, MD, MSc||Vanessa.firstname.lastname@example.org|
|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|
|Principal Investigator:||Ramin Herati, MD||NYU Langone Health|