NIH Reporter #5U01AI167786-04

NIH/NIAID Solicitation for First-in-Human Study of HepB mAb19 Monoclonal Antibody in Chronic Hepatitis B

This opportunity is a clinical research procurement from the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, focused on hepatitis B immunotherapy. - Government Buyer: - National Institutes of Health (NIH) - National Institute of Allergy and Infectious Diseases (NIAID) - Project Scope: - Soliciting proposals for a first-in-human, dose-escalation clinical study - Study involves a long-acting variant of HepB mAb19 monoclonal antibody - Target population: individuals with chronic hepatitis B (CHB) on antiviral therapy - Primary objectives: assess safety, tolerability, and efficacy of the antibody - Focus on reduction of circulating HBsAg levels and immune response evaluation - Products/Services Requested: - Clinical trial design and execution - Supply and administration of HepB mAb19 monoclonal antibody (no part numbers specified) - Data collection and analysis on safety and efficacy endpoints - Notable Requirements: - First-in-human study (no prior human data for this antibody) - Emphasis on immunological endpoints and antiviral therapy background - OEMs and Vendors: - No specific OEMs or vendors named in the notice - No detailed product or service line items provided in the solicitation

Description

This NIH-funded project aims to evaluate the safety, tolerability, and efficacy of a long-acting monoclonal antibody in treating chronic hepatitis B. The study will assess the impact on circulating HBsAg levels and immune responses. It involves a first-in-human dose-escalation study of a long-acting variant of HepB mAb19 in individuals with chronic hepatitis B on antiviral therapy. The project duration is from March 1, 2026, to February 28, 2027, and is managed by the NIH/NIAID with a focus on immunotherapy for hepatitis B.

View original listing