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Virus Therapy
HEPLISAV-B Vaccine for HIV-Associated Hepatitis B (BEe-HIVe Trial)
Phase 3
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
On current HIV-1 antiretroviral therapy (ART)
HIV-1 infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4, 8, 12, 24, 28, 32, 48, 52 and 72
Awards & highlights
BEe-HIVe Trial Summary
This trial will test a new hepatitis B vaccine in people living with HIV who haven't responded to other vaccines or who haven't been vaccinated before.
Who is the study for?
This trial is for people living with HIV who either have never had the HBV vaccine or got it but didn't respond. They must be on HIV treatment, have a CD4+ T-cell count of at least 100 cells/mm^3, and show no active Hepatitis B infection.Check my eligibility
What is being tested?
The study tests the response to HEPLISAV-B vaccine in two groups: those previously vaccinated for HBV without success (non-responders) and those not yet vaccinated against HBV. It aims to see how well they respond and monitor safety.See study design
What are the potential side effects?
Potential side effects are not detailed here, but generally, vaccines like HEPLISAV-B may cause reactions at the injection site, muscle pain, fatigue, headache or mild fever.
BEe-HIVe Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently on HIV-1 antiretroviral therapy.
Select...
I am infected with HIV-1.
BEe-HIVe Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 4, 8, 12, 24, 28, 32, 48, 52 and 72
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8, 12, 24, 28, 32, 48, 52 and 72
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurrence of Adverse events (AEs)
Seroprotection response defined as hepatitis B virus surface antibody (HBsAb) ≥10 mIU/mL
Secondary outcome measures
HBsAb titer
Occurrence of Grade ≥2 AEs within 4 weeks after each injection
Seroprotection response defined as HBsAb ≥10 mIU/mL
Side effects data
From 2012 Phase 3 trial • 521 Patients • NCT009854266%
Fatigue
6%
Oedema peripheral
6%
Arthralgia
5%
Nasopharyngitis
5%
Urinary tract infection
4%
Renal failure chronic
4%
Hypokalaemia
4%
Upper respiratory tract infection
4%
Hyperkalaemia
4%
Anaemia
4%
Constipation
4%
Diarrhoea
4%
Nausea
4%
Bronchitis
4%
Headache
4%
Cough
3%
Cardiac failure congestive
3%
Gout
3%
Pain in extremity
3%
Gastroenteritis
3%
Sinusitis
3%
Cataract
3%
Blood creatine phosphokinase increased
3%
Dyspnoea
3%
Hypertension
2%
Hyperphosphataemia
2%
Renal failure acute
2%
Hypoglycaemia
2%
Vomiting
2%
Musculoskeletal pain
2%
Metabolic acidosis
2%
Muscle spasms
2%
Dizziness
2%
Insomnia
2%
Pneumonia
2%
Oropharyngeal pain
2%
Hypotension
1%
Staphylococcal sepsis
1%
Non-cardiac chest pain
1%
Acute myocardial infarction
1%
Angina unstable
1%
Myocardial infarction
1%
Myalgia
1%
Clostridium difficile colitis
1%
Diabetic foot
1%
Pulmonary oedema
1%
Back pain
1%
Hypertensive crisis
1%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
HEPLISAV-B
Engerix-B
BEe-HIVe Trial Design
4Treatment groups
Experimental Treatment
Group I: Group B: HEPLISAV-B (three injections)Experimental Treatment1 Intervention
Participants will receive 0.5 mL of HEPLISAV-B by IM injection at Weeks 0, 4, and 24.
Group II: Group A, Arm 3: ENGERIX-B (three injections)Experimental Treatment1 Intervention
Participants will receive 1 mL of ENGERIX-B by IM injection at Weeks 0, 4, and 24.
Group III: Group A, Arm 2: HEPLISAV-B (three injections)Experimental Treatment1 Intervention
Participants will receive 0.5 mL of HEPLISAV-B by IM injection at Weeks 0, 4, and 24.
Group IV: Group A, Arm 1: HEPLISAV-B (two injections)Experimental Treatment1 Intervention
Participants will receive 0.5 mL of HEPLISAV-B by intramuscular (IM) injection at Weeks 0 and 4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HEPLISAV-B
2018
Completed Phase 3
~600
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,480,492 Total Patients Enrolled
Dynavax Technologies CorporationIndustry Sponsor
28 Previous Clinical Trials
16,740 Total Patients Enrolled
Kenneth E. Sherman, MD, PhDStudy ChairCincinnati CRS
3 Previous Clinical Trials
373 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have gotten the hepatitis B vaccine at least 168 days before starting the study.Requirements to be included in Group A and B.You can only be part of Group A for this study.This criterion only applies to participants in Group B who meet the requirements.I am currently on HIV-1 antiretroviral therapy.You have a minimum of 100 CD4+ T-cells per cubic millimeter of blood.You tested negative for Hepatitis B antibodies in the 45 days before the study.Your blood test shows that you do not have enough hepatitis B antibodies or you tested negative or the results were unclear.You have a low level of HIV-1 virus in your blood (less than 1000 copies/mL).I am infected with HIV-1.
Research Study Groups:
This trial has the following groups:- Group 1: Group B: HEPLISAV-B (three injections)
- Group 2: Group A, Arm 1: HEPLISAV-B (two injections)
- Group 3: Group A, Arm 3: ENGERIX-B (three injections)
- Group 4: Group A, Arm 2: HEPLISAV-B (three injections)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
HIV/AIDS Patient Testimony for trial: Trial Name: NCT04193189 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment include any test subjects who are over 55 years old?
"According to the rules set for this clinical trial, anyone aged 18-70 is eligible to participate."
Answered by AI
Are there any other investigational studies currently underway examining HEPLISAV-B?
"The first study for HEPLISAV-B was conducted in 2012 at Tel Aviv Sourasky Medical Center Dialysis Unit. A total of 243 have been completed to date with 30 more presently active. The majority of these are located in Pittsburgh, Pennsylvania."
Answered by AI
Are we enrolling patients for this treatment study at this time?
"Yes, this trial is recruiting patients as of September 29th, 2022. The listing was first created on December 14th, 2020."
Answered by AI
Is this clinical trial being run in numerous hospitals throughout the state?
"The University of Pittsburgh CRS, Vanderbilt Therapeutics (VT) CRS, and Cincinnati Clinical Research Site are the primary locations for this trial. However, there are an additional 30 sites also participating in this study."
Answered by AI
What is the probability of a patient developing complications from HEPLISAV-B?
"HEPLISAV-B's safety is upheld by multiple rounds of data, as is common for Phase 3 trials. Consequently, our team rates the safety a 3."
Answered by AI
To qualify for this research, what criteria must a person meet?
"This trial is looking for 634 individuals that have hepatitis b and are between 18-70 years old. Furthermore, the participants must meet the following requirements: 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"
Answered by AI
Who else is applying?
What state do they live in?
Other
Texas
Illinois
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
What site did they apply to?
Alabama CRS
Columbia P&S CRS
Why did patients apply to this trial?
I'm interested in talking study.
PatientReceived no prior treatments
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