37 Participants Needed

HepB mAb19 for Chronic Hepatitis B

Recruiting at 1 trial location
RS
MC
Overseen ByMarina Caskey, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Rockefeller University
Must be taking: Nucleos(t)ide analogs

What You Need to Know Before You Apply

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.12345

Who Is on the Research Team?

MC

Marina Caskey, MD

Principal Investigator

The Rockefeller University

Are You a Good Fit for This Trial?

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.
Negative serum or urine pregnancy test at screening and on day 0 for participants who can become pregnant
My partner is sterile, confirmed by tests, and is my only partner.
See 8 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
See 13 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • HepB mAb19
Trial Overview 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.
How Is the Trial Designed?
9Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 5: Maximum tolerated dose, IVExperimental Treatment1 Intervention
Group II: Group 4a: HepB mAb19 30 mg/kg, IVExperimental Treatment1 Intervention
Group III: Group 3a: HepB mAb19 10 mg/kg, IVExperimental Treatment1 Intervention
Group IV: Group 2a: HepB mAb19 3 mg/kg, IVExperimental Treatment1 Intervention
Group V: Group 1a: HepB mAb19 1 mg/kg, IVExperimental Treatment1 Intervention
Group VI: Group 2b: Placebo 3 mg/kg, IVPlacebo Group1 Intervention
Group VII: Group 1b: Placebo 1 mg/kg, IVPlacebo Group1 Intervention
Group VIII: Group 4b: Placebo 30 mg/kg, IVPlacebo Group1 Intervention
Group IX: Group 3b: Placebo 10 mg/kg, IVPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rockefeller University

Lead Sponsor

Trials
162
Recruited
16,700+

NYU Langone Health

Collaborator

Trials
1,431
Recruited
838,000+

Published Research Related to This Trial

In a study involving 43,618 Alaska natives who received 101,360 doses of the hepatitis B vaccine, only 39 individuals reported possible adverse reactions, indicating a low incidence of serious side effects.
The most common adverse reactions were mild and included prolonged myalgia/arthralgia, skin rashes, and dizziness, with no increased risk of Guillain-Barrรฉ syndrome found among vaccine recipients, supporting the vaccine's overall safety.
Frequency of adverse reactions to hepatitis B vaccine in 43,618 persons.McMahon, BJ., Helminiak, C., Wainwright, RB., et al.[2019]
The Hepatitis A Inactivated and Hepatitis B Recombinant Vaccine (HEPAB), approved by the FDA in May 2001, received 305 reports of adverse events from May 2001 to September 2003, with most being non-serious like local reactions and constitutional symptoms.
Serious adverse events were reported, but a thorough review found no clear causal relationship with the vaccine, aside from injection site reactions and some allergic responses, indicating that HEPAB is generally safe for immunization in adults.
Adverse events after hepatitis A B combination vaccine.Woo, EJ., Miller, NB., Ball, R.[2006]
A total of 20,231 adverse event reports were received following hepatitis B vaccinations from 2005 to 2015, with the most common side effects being dizziness and nausea for single antigen vaccines, and fever and injection site erythema for combination vaccines.
The review found no new or unexpected safety concerns with the current hepatitis B vaccines, but highlighted the need for improved training for healthcare providers to prevent vaccination errors.
Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005-2015.Haber, P., Moro, PL., Ng, C., et al.[2018]

Citations

Frequency of adverse reactions to hepatitis B vaccine in 43,618 persons. [2019]
Adverse events after hepatitis A B combination vaccine. [2006]
Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005-2015. [2018]
A review of hepatitis B vaccination. [2019]
Neonatal deaths after hepatitis B vaccine: the vaccine adverse event reporting system, 1991-1998. [2019]
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