A Phase 1/2a Clinical Trial Study to Evaluate the Efficacy of MEDI8852 in the Treatment of Influenza in Adults Challenged with a Wild-Type Influenza Strain
Abstract
MedImmune is developing MEDI8852, a monoclonal antibody, for the treatment of patients who are hospitalized with influenza caused by Type A strains. Development of MEDI8852 for the treatment of influenza falls under the Fiscal Year 2017 Peer Reviewed Medical Research Program Topic Area of Influenza and aligns with the Area of Encouragement: Development and evaluation of novel, innovative, and/or combination influenza therapies. Type A strains are responsible for about 75% of hospitalizations due to influenza and monoclonal antibodies are antibodies that have very specific targets: MEDI8852 binds to a protein that is found on the surface of Type A influenza viruses and stops the viruses from entering cells. MEDI8852 also helps to remove cells that have already been infected by the flu virus. In animal studies, MEDI8852 was shown to protect against influenza infections that would have been lethal, even when the animals were treated a number of days after they were infected. In these studies, MEDI8852 was also more effective than oseltamivir, a medicine that is commonly used to treat patients with influenza. The purpose of the proposed study is to evaluate whether a higher dose of MEDI8852 can reduce the amount of influenza virus as well as the symptoms that subjects who are infected with flu have. The main difference between this study and the previous studies, described below, is that a higher dose of MEDI8852 will be evaluated. The purpose of study is to see if the higher dose will be more effective than oseltamivir and to see if combining MEDI8852 with oseltamivir is more effective than just giving subjects oseltamivir alone. Two previous studies have been conducted with MEDI8852 in humans. In both studies, the antibody was given intravenously (through a vein). The first study looked at the safety of different dose levels of the antibody in healthy adults. MEDI8852 did not show any safety concerns in this study up to the highest dose that was studied, 3,000 mg. In the second study, patients who were sick with influenza, but not hospitalized, were given MEDI8852 to see if it would decrease the amount of influenza virus in their bodies and to see if it would help resolve their flu symptoms. In this study MEDI8852 decreased the amount of flu virus and the patients’ symptoms to the same extent as oseltamivir did. In the proposed study, in order to carefully evaluate the effects of MEDI8852, adult subjects 18 to 65 years of age will be studied as inpatients at a research site. In the first part of the study, eight subjects will receive the higher dose of MEDI8852 to evaluate the safety of this dose level. Once the safety has been assessed, the second part of the study will begin. The second part will involve a new set of subjects, who will be admitted to the inpatient site. The day after admission (Day 1) they will be infected with a flu virus that has been shown in previous studies to cause infections but not severe illness. On Day 2 the subjects will be randomly assigned to one of 5 groups (12 subjects per group) to see how different treatments affect the amount of virus they have and their flu symptoms. Group 1 will be given placebo; Group 2 will be given oseltamivir twice a day for 5 days; Group 3 will be given a lower dose of MEDI8852; Group 4 will be given a lower dose of MEDI8852 and oseltamivir twice a day for 5 days; and Group 5 will be given a higher dose of MEDI8852. For the next 7 days, all of the subjects will have their flu symptoms assessed twice a day and will also have nasal swabs taken twice a day to quantify how much flu virus they have. The subjects will then be discharged from the inpatient unit and will be followed in the study for a total of 60 days. During this period, they will be asked about any adverse events they might have experienced. The subjects will also come back to the study site on Day 30 and Day 60 to have their blood drawn to see if they developed immune resp
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Oct 29, 2018
- Source ID
- W81XWH1810606
Entities
People
- Raburn Mallory
Organizations
- AstraZeneca (United States)
- United States Army