B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B (BEe-HIVe)
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| ClinicalTrials.gov Identifier: NCT04193189 |
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Recruitment Status :
Active, not recruiting
First Posted : December 10, 2019
Last Update Posted : March 8, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infection Hepatitis B | Biological: HEPLISAV-B Biological: ENGERIX-B | Phase 3 |
This phase III/IV study will evaluate the response to and safety of the HBV vaccine HEPLISAV-B in two study populations living with HIV: prior HBV vaccine recipients who are deemed non-responders (Group A) and individuals who are naïve to HBV vaccination (Group B).
Group A (HBV vaccine non-responders)
The study is designed as an open-label three-arm study to evaluate whether:
- HEPLISAV-B vaccination given as a two-dose series achieves non-inferior seroprotection response (SPR) compared to standard dose ENGERIX-B.
- HEPLISAV-B vaccination given as a three-dose series achieves superior SPR proportion compared to standard dose ENGERIX-B.
Participants are randomized in 1:1:1 ratio to the following study arms, stratified by sex at birth (male vs. female) and diabetes diagnosis status (yes vs. no):
- Arm 1: Two doses of HEPLISAV-B at weeks 0 and 4.
- Arm 2: Three doses of HEPLISAV-B at weeks 0, 4, and 24.
- Arm 3: Three doses of ENGERIX-B at weeks 0, 4, and 24.
The target sample size in Group A is 561 participants, 187 participants in each arm.
Group B (Naïve to HBV vaccination)
Group B study is a single arm evaluation of vaccine response and safety of three doses of HEPLISAV-B. The target sample size is 73 participants.
All participants will remain on their non-study-provided antiretroviral therapy (ART) throughout the study. Participants in both groups will attend several study visits through Week 72. Visits may include physical examinations and blood collection. For 7 days after each vaccination, participants will record temperature and any reactions they have to the vaccine.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 640 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B |
| Actual Study Start Date : | December 14, 2020 |
| Estimated Primary Completion Date : | June 1, 2024 |
| Estimated Study Completion Date : | June 1, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group A, Arm 1: HEPLISAV-B (two injections)
Participants will receive 0.5 mL of HEPLISAV-B by intramuscular (IM) injection at Weeks 0 and 4.
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Biological: HEPLISAV-B
Administered by IM injection |
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Experimental: Group A, Arm 2: HEPLISAV-B (three injections)
Participants will receive 0.5 mL of HEPLISAV-B by IM injection at Weeks 0, 4, and 24.
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Biological: HEPLISAV-B
Administered by IM injection |
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Experimental: Group A, Arm 3: ENGERIX-B (three injections)
Participants will receive 1 mL of ENGERIX-B by IM injection at Weeks 0, 4, and 24.
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Biological: ENGERIX-B
Administered by IM injection |
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Experimental: Group B: HEPLISAV-B (three injections)
Participants will receive 0.5 mL of HEPLISAV-B by IM injection at Weeks 0, 4, and 24.
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Biological: HEPLISAV-B
Administered by IM injection |
- Seroprotection response defined as hepatitis B virus surface antibody (HBsAb) ≥10 mIU/mL [ Time Frame: Week 12 in Group A, Arm 1, Week 28 in Group A, Arms 2 and 3 and in Group B ]
- Occurrence of Adverse events (AEs) [ Time Frame: From vaccination initiation to study discontinuation (Week 72 or premature discontinuation) ]DAIDS AE Grading Table (Version 2.1) will be used.
- Seroprotection response defined as HBsAb ≥10 mIU/mL [ Time Frame: Weeks 4, 8, 12, 24, 28, 32, 48, 52 and 72 ]
- HBsAb titer [ Time Frame: Weeks 4, 8, 12, 24, 28, 32, 48, 52 and 72 ]
- Occurrence of Grade ≥2 AEs within 4 weeks after each injection [ Time Frame: From vaccination initiation to Week 28 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria, Groups A and B
- HIV-1 infection
- On current HIV-1 antiretroviral therapy (ART)
- CD4+ T-cell count ≥100 cells/mm^3
- HIV-1 RNA <1000 copies/mL
Inclusion Criteria, Group A only
- Serum Hepatitis B antibody <10 mlU/mL, non-reactive (negative), or indeterminate
- Documentation of HBV vaccination >168 days prior to study entry
Inclusion Criterion, Group B only
- Serum Hepatitis B antibody non-reactive (negative) within 45 days prior to study entry
Exclusion Criteria, Groups A and B
- Infection or prior exposure to HBV
- Serum HBsAb level ≥10 mlU/mL or positive at screening or any other time prior to screening
- Presence of any active or acute AIDS-defining opportunistic infections
- Solid organ transplantation
- History of ascites, encephalopathy, or variceal hemorrhage
- Diagnosis of chronic kidney disease (CKD) stage G4
- Cancer diagnosis within 5 years
- Currently receiving chemotherapy
- Chronic use and/or receipt of systemically administered immunosuppressive
- Known allergy/sensitivity or any hypersensitivity to any HBV vaccine or yeast
- Active, serious infection other than HIV-1
- Receipt of any inactivated virus vaccine within 14 days
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Receipt of any of the following within 45 days prior to study entry:
- Live virus vaccine
- Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)
- Any other investigational medicinal agent
- Receipt of immunoglobulin or blood products within 90 days prior to study entry
- Receipt of an injection of DNA plasmids or oligonucleotides within 60 days prior to study entry
Exclusion Criteria, Group A only
- Hepatitis B virus vaccination ≤168 days prior to study entry
- Receipt of HEPLISAV-B vaccine at any time prior to study entry
Exclusion Criterion, Group B only
- Known HBV vaccination prior to study entry
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): NCT04193189
Show 47 study locations
| Study Chair: | Kenneth E. Sherman, MD, PhD | Cincinnati CRS | |
| Study Chair: | Kristen Marks, MD | Weill Cornell Chelsea CRS |
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT04193189 |
| Other Study ID Numbers: |
ACTG A5379 38569 ( Registry Identifier: DAIDS-ES Registry Number ) |
| First Posted: | December 10, 2019 Key Record Dates |
| Last Update Posted: | March 8, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Individual participant data that underlie results in the publication, after deidentification. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH. |
| Access Criteria: |
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| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Hepatitis B Hepatitis Hepatitis, Viral, Human Liver Diseases Digestive System Diseases Blood-Borne Infections |
Communicable Diseases Infections Virus Diseases Hepadnaviridae Infections DNA Virus Infections |