Vaccine ReactionPhase 4NCT04674462
Understanding Poor Vaccine Responses to Hepatitis B Vaccination
A Phase 4 study testing CpG-adjuvanted HBV Vaccine and Traditional HBV Vaccine in people with Vaccine Reaction, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Reaction
- What is being tested?
- CpG-adjuvanted HBV Vaccine and Traditional HBV Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2022to Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Must be able to understand and sign the Informed Consent Form (ICF)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- CpG-adjuvanted HBV Vaccine, Traditional HBV Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CpG-adjuvanted HBV VaccineBiological
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 VaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| CpG-adjuvanted HBV Vaccine | Experimental | Not described Receives: Biological: CpG-adjuvanted HBV Vaccine |
| Traditional HBV Vaccine | Active comparator | Not described Receives: Biological: Traditional HBV Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Month 1 Post-Final Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start7 Jul 2022
- Primary completion9 Jun 2026
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ReactionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramin Herati, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674462
- Sponsor's protocol ID
- 20-01782
- Status last verified
- Oct 2026
- First submitted
- 14 Dec 2020
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Poor Vaccine Responses to Hepatitis B Vaccination
- ClinicalTrials.gov ID
- NCT04674462
- Acronym / sponsor ID
- 20-01782
- Conditions
- Vaccine Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 101 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 9 Jun 2026 (actual)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CpG-adjuvanted HBV Vaccine | Experimental | Biological: CpG-adjuvanted HBV Vaccine |
| Traditional HBV Vaccine | Active comparator | Biological: Traditional HBV Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age
- Must be able to understand and sign the Informed Consent Form (ICF)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CpG-adjuvanted HBV VaccineSubjects 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 | CpG-adjuvanted HBV Vaccine |
| Traditional HBV VaccineSubjects 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. | Biological | Traditional HBV Vaccine |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Related trials for Vaccine Reaction
RecruitingEarly Phase 1
Intradermal Influenza Vaccination
Vaccine Reaction
RecruitingPhase 1
Phase 1b Ascending Dose Study of PanChol in Healthy Volunteers
Cholera Vaccination Reaction
Not yet recruitingPhase 4
R21/MM Dosing, Presentations, and Preservatives
Plasmodium Falciparum Malaria, Malaria
RecruitingObservational study
Reduced Vaccine Response to HZ/su in SLE
Vaccine Reaction, Zoster
Active, not recruitingPhase 1
Study of an RSV-hMPV-PIV3 Trivalent Vaccine Candidate VXB-251 in Older Adults
Lower Respiratory Tract Disease, Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramin Herati, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CpG-adjuvanted HBV Vaccine and Traditional HBV Vaccine in people with Vaccine Reaction, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Weak Vaccine Response (time frame: Month 1 Post-Final Dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.