Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody: a First-in-human Phase 1, Placebo-controlled, Single Dose Escalation Clinical Trial in Individuals with Chronic Hepatitis B Infection (The SAMBA Study)

Hepatitis B virus (HBV) remains a major global health problem with an estimated 257 million people living with the infection worldwide. Chronic HBV (CHB) is a major cause of liver cirrhosis and hepatocellular carcinoma. While antiviral therapies are available and suppress viral levels, treatment is long-term, does not clear the infection and rarely leads to long-term control once discontinued. Moreover, treatment access is not ideal on a global level with less than 10% of people in need receiving treatment. Although a strategy that eliminates all viral particles from the body represents the "holy grail" of HBV therapy, a strategy that leads to HBsAg loss and allows patients to stop treatment is highly desirable. New strategies to achieve either complete viral clearance or a state of viral control without the need for long-term treatment are being developed, including approaches to restore immune responses. Antibodies are key modulators of immune responses because of their dual functionality. In addition to directly targeting a viral antigen, antibodies differ from direct antivirals in that they can recruit other immune cells to eliminate infected cells and accelerate viral clearance.
This study will evaluate the safety and pharmacokinetics of a monoclonal antibody that was isolated from an HBV-vaccinated individual, HepB mAb19, as well as its potential effects on viral levels and antiviral immune responses in individuals living with CHB.

开始日期2024-08-26

申办/合作机构

Århus Universitetshospital

[+1]

NCT05856890 / Recruiting临床1期IIT

A Phase 1, Placebo-controlled, Dose-escalation Study of the Safety, Pharmacokinetics, and Antiviral Activity of a Potent Neutralizing Monoclonal Antibody in Individuals With Chronic Hepatitis B Infection

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).

开始日期2023-08-07

申办/合作机构

The Rockefeller University

[+1]

100 项与 HepB mAb19 相关的临床结果

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100 项与 HepB mAb19 相关的转化医学

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100 项与 HepB mAb19 相关的专利（医药）

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项与 HepB mAb19 相关的文献（医药）

2018-01-01·Vaccine3区 · 医学

Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005–2015

3区 · 医学

Article

作者: Nelson, Noele P ; Moro, Pedro L ; Stewart, Brock ; Haber, Penina ; Hibbs, Beth ; Lewis, Paige W ; Schillie, Sarah F ; Ng, Carmen ; Li, Rongxia ; Cano, Maria V

INTRODUCTIONCurrently 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.METHODSWe searched VAERS for reports of AEs following single antigen HepB vaccine and HepB-containing vaccines (either given alone or with other vaccines), from January 2005 - December 2015. We conducted descriptive analyses and performed empirical Bayesian data mining to assess disproportionate reporting. We reviewed serious reports including reports of special interest.RESULTSVAERS received 20,231 reports following HepB or HepB-containing vaccines: 10,291 (51%) in persons <2 years of age; 2588 (13%) in persons 2-18 years and 5867 (29%) in persons >18 years; for 1485 (7.3%) age was missing. Dizziness and nausea (8.4% each) were the most frequently reported AEs following a single antigen HepB vaccine: fever (23%) and injection site erythema (11%) were most frequent following Hep-containing vaccines. Of the 4444 (22%) reports after single antigen HepB vaccine, 303 (6.8%) were serious, including 45 deaths. Most commonly reported cause of death was Sudden Infant Death Syndrome (197). Most common non-death serious reports following single antigen HepB vaccines among infants aged <1 month, were nervous system disorders (15) among children aged 1-23 months; infections and infestation (8) among persons age 2-18 years blood and lymphatic systemic disorders; and general disorders and administration site conditions among persons age >18 years. Most common vaccination error following single antigen HepB was incorrect product storage.CONCLUSIONSReview current U.S.-licensed HepB vaccines administered alone or in combination with other vaccines did not reveal new or unexpected safety concerns. Vaccination errors were identified which indicate the need for training and education of providers on HepB vaccine indications and recommendations.

2015-01-01·Revista de Saúde Pública4区 · 医学

Polio inactivated vaccine costs into routine childhood immunization in Brazil

4区 · 医学

ArticleOA

作者: Gryninger, Lígia Castelloni Figueiredo ; Vicentine, Margarete Paganotti ; Novaes, Hillegonda Maria Dutilh ; Soárez, Patricia Coelho de ; Sartori, Ana Marli Christovam

OBJECTIVE To analyze the costs of vaccination regimens for introducing inactivated polio vaccine in routine immunization in Brazil.METHODS A cost analysis was conducted for vaccines in five vaccination regimens, including inactivated polio vaccine, compared with the oral polio vaccine-only regimen. The costs of the vaccines were estimated for routine use and for the “National Immunization Days”, during when the oral polio vaccine is administered to children aged less than five years, independent of their vaccine status, and the strategic stock of inactivated polio vaccine. The presented estimated costs are of 2011.RESULTS The annual costs of the oral vaccine-only program (routine and two National Immunization Days) were estimated at US$19,873,170. The incremental costs of inclusion of the inactivated vaccine depended on the number of vaccine doses, presentation of the vaccine (bottles with single dose or ten doses), and number of “National Immunization Days” carried out. The cost of the regimen adopted with two doses of inactivated vaccine followed by three doses of oral vaccine and one “National Immunization Day” was estimated at US$29,653,539. The concomitant replacement of the DTPw/Hib and HepB vaccines with the pentavalent vaccine enabled the introduction of the inactivated polio without increasing the number of injections or number of visits needed to complete the vaccination.CONCLUSIONS The introduction of the inactivated vaccine increased the annual costs of the polio vaccines by 49.2% compared with the oral vaccine-only regimen. This increase represented 1.13% of the expenditure of the National Immunization Program on the purchase of vaccines in 2011.

2010-09-17·MMWR. Morbidity and mortality weekly report

National, state, and local area vaccination coverage among children aged 19-35 months --- United States, 2009.

Article

Since 1994, the National Immunization Survey (NIS) has been collecting data to monitor childhood immunization coverage. This report describes the 2009 NIS coverage estimates for children born during January 2006--July 2008 and focuses on the more recently recommended vaccines (i.e., hepatitis B [HepB] vaccine birth dose, hepatitis A vaccine [HepA], pneumococcal conjugate vaccine [PCV], and rotavirus vaccine) for children aged 19--35 months. The most recent NIS data indicate that vaccination coverage increased in 2009 compared with 2008 for HepB birth dose (from 55.3% to 60.8%) and HepA (from 40.4% to 46.6%), but coverage for PCV (≥4 doses) remained stable (80.4%). Full coverage for rotavirus vaccine was 43.9% among children born within 2 years of licensure. Coverage for poliovirus (92.8%), measles, mumps, and rubella (MMR) (90.0%), hepatitis B (HepB) (92.4%), and varicella (VAR) (89.6%) vaccines continued to be at or near the national health objective of 90%, although coverage for MMR and HepB vaccines decreased slightly in 2009. The percentage of children who have not received any vaccines remained low (<1%). Parents and primary-care providers continued to ensure that children were vaccinated, in spite of interim recommendations to suspend the booster dose of Haemophilus influenzae type b vaccine (Hib) because of a national shortage, and heightened public awareness of controversies in vaccine safety.

100 项与 HepB mAb19 相关的药物交易

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