HepB mAb19 for Chronic Hepatitis B
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Rockefeller University
Must be taking: Nucleos(t)ide analogs
Must not be taking: Systemic corticosteroids, Immunosuppressive
Disqualifiers: Advanced fibrosis, HIV, HCV, others
Trial Summary
What is the purpose of this trial?This is a first-in-human, placebo-controlled, single dose, dose-escalation phase 1 study to evaluate the safety, pharmacokinetics and antiviral activity of a highly potent neutralizing anti-HBV monoclonal antibody (mAb), HepB mAb19, which targets the S-protein in individuals with chronic hepatitis B (CHB) on nucleos(t)ide analog therapy (NRTI).
Do I need to stop my current medications for the trial?
The trial requires participants to continue their current HBV-active nucleos(t)ide therapy without changes for at least 3 months before joining. The protocol does not specify if other medications need to be stopped.
What safety data exists for HepB mAb19 or similar treatments?
The safety of hepatitis B vaccines, which may be similar to HepB mAb19, has been generally accepted, though some adverse reactions like injection site reactions and allergic reactions have been reported. Serious events are rare and not clearly linked to the vaccine, and the benefits are considered to outweigh the risks.
12345Eligibility Criteria
Adults aged 18-70 with chronic Hepatitis B on nucleos(t)ide therapy for at least 6 months can join. They must not be pregnant, agree to use contraception, and have a stable viral load. Excluded are those with severe allergies, heart disease, recent acute infections, advanced liver fibrosis or cancerous liver lesions.Inclusion Criteria
I have been on stable hepatitis B treatment for at least 6 months.
I am between 18 and 70 years old.
Negative serum or urine pregnancy test at screening and on day 0 for participants who can become pregnant
+9 more
Exclusion Criteria
HIV-1, HCV or hepatitis delta virus infection within 12 months from entry or done at screen
I haven't taken steroids, immunosuppressants, or certain cancer drugs in the last 6 months.
Confirmed significant allergic reactions against any drug, monoclonal antibody or vaccine, or multiple drug allergies
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a single intravenous infusion of HepB mAb19 or placebo at one of four increasing dose levels
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety, pharmacokinetics, and antiviral activity for 48 weeks after infusion
48 weeks
Participant Groups
The trial is testing HepB mAb19, an experimental antibody targeting the hepatitis B virus in patients already on standard treatment. It's compared against a placebo (sterile saline). The study will look at safety and how well it works to control the virus.
9Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 5: Maximum tolerated dose, IVExperimental Treatment1 Intervention
Single intravenous infusion of HepB mAb19, dosed at the MTD
Group II: Group 4a: HepB mAb19 30 mg/kg, IVExperimental Treatment1 Intervention
Single intravenous infusion of HepB mAb19, dosed at 30 mg/kg.
Group III: Group 3a: HepB mAb19 10 mg/kg, IVExperimental Treatment1 Intervention
Single intravenous infusion of HepB mAb19, dosed at 10 mg/kg.
Group IV: Group 2a: HepB mAb19 3 mg/kg, IVExperimental Treatment1 Intervention
Single intravenous infusion of HepB mAb19, dosed at 3 mg/kg.
Group V: Group 1a: HepB mAb19 1 mg/kg, IVExperimental Treatment1 Intervention
Single intravenous infusion of HepB mAb19, dosed at 1 mg/kg.
Group VI: Group 2b: Placebo 3 mg/kg, IVPlacebo Group1 Intervention
Single intravenous infusion of placebo - normal saline, dosed at 3 mg/kg.
Group VII: Group 1b: Placebo 1 mg/kg, IVPlacebo Group1 Intervention
Single intravenous infusion of placebo - normal saline, dosed at 1 mg/kg.
Group VIII: Group 4b: Placebo 30 mg/kg, IVPlacebo Group1 Intervention
Single intravenous infusion of placebo - normal saline, dosed at 30 mg/kg.
Group IX: Group 3b: Placebo 10 mg/kg, IVPlacebo Group1 Intervention
Single intravenous infusion of placebo - normal saline, dosed at 10 mg/kg.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Rockefeller UniversityNew York, NY
NYU Langone HealthNew York, NY
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Who Is Running the Clinical Trial?
Rockefeller UniversityLead Sponsor
NYU Langone HealthCollaborator
References
Frequency of adverse reactions to hepatitis B vaccine in 43,618 persons. [2019]To determine the incidence of adverse reactions to hepatitis B plasma-derived vaccine.
Adverse events after hepatitis A B combination vaccine. [2006]In May 2001, the U.S. Food and Drug Administration (FDA) approved Hepatitis A Inactivated and Hepatitis B Recombinant Vaccine (HEPAB) for immunization of adults. From May 2001 to September 2003, the Vaccine Adverse Event Reporting System (VAERS) received 305 reports of adverse events after HEPAB. Many events were similar to those reported after the monovalent hepatitis A and B vaccines. Non-serious events included constitutional symptoms and local reactions. Serious events included neurologic, hepatobiliary, and dermatologic conditions, and detailed medical and epidemiological review did not suggest a clear pattern of evidence supporting a causal relationship with the vaccine, except for injection site reactions and some allergic reactions.
Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005-2015. [2018]Currently four recombinant hepatitis B (HepB) vaccines are in use in the United States. HepB vaccines are recommended for infants, children and adults. We assessed adverse events (AEs) following HepB vaccines reported to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system.
A review of hepatitis B vaccination. [2019]Hepatitis B is one of the most important infectious causes of acute and chronic liver disease both in the US and worldwide. In order to combat the life-threatening effects of hepatitis B infection, recombinant hepatitis B vaccines have been developed. The medical and scientific communities have generally accepted that recombinant hepatitis B vaccine - a highly purified, genetically engineered, single antigen vaccine - is a safe vaccine. Information is presented showing that hepatitis B vaccine contains yeast, aluminium, thimerosal and hepatitis B surface antigen epitopes, which may result in hepatitis B vaccine being associated with autoimmune diseases among susceptible adult vaccine recipients. There is little doubt that the benefits of this vaccine overall far outweigh its risks. Physicians and patients should evaluate the risks and benefits of hepatitis B vaccination and, together, make an informed consent decision as to whether to undergo vaccination. Individuals who experience an adverse reaction to hepatitis B vaccination should report it to the Vaccine Adverse Event Reporting System database and be advised that they may be eligible for compensation from the no-fault National Vaccine Injury Compensation Program, administered by the US Court of Claims. The authors strongly urge that additional research be conducted into the molecular basis of adverse events following hepatitis B vaccine administration, so that further recommendations may be made on how to improve their safety profiles.
Neonatal deaths after hepatitis B vaccine: the vaccine adverse event reporting system, 1991-1998. [2019]To evaluate reports of neonatal deaths (aged 0-28 days) after hepatitis B (HepB) immunization reported to the national Vaccine Adverse Event Reporting System (VAERS).