A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)

About this Study

This study will evaluate the safety and tolerability of MEDI8897 compared to palivizumab in preterm infants entering their first RSV season and children with chronic lung disease or congenital heart disease entering their first and second RSV season.

Sponsor Protocol ID:	D5290C00005
IRB Number:	2019-0209
Study Status: Study Status Actively Enrolling: The study is currently recruiting participants. Closed for Enrollment: The study is not currently recruiting participants.	Actively Enrolling
Study Type: Study Type Interventional: A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. Observational: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment. A patient registry is a type of observational study.	Interventional
Study Phase: Study Phase Early Phase 1 Trials (formerly listed as Phase 0): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies). Phase 1 Trials: Trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants. Phase 2 Trials: Trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. Phase 3 Trials: Trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants. Phase 4 Trials: Trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.	Phase 2
Online Start Date: Online Start Date The online start date is the day that this trial first appeared on the UMMC website, which is not necessarily the day that the trial first began at UMMC.	November 25, 2019

Eligibility Criteria

Biological Sex Biological Sex Requirement Indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.	Both Male and Female
Cancer Related? Cancer Related Some studies may be targeted to cancer-related treatments or research. Please read the study description and additional eligibility criteria for specific information.	No
Pediatric Related? Pediatric Related Some studies may be targeted to child-related treatments or research. Please read the study description and additional eligibility criteria for specific information.	Yes
Accepts Healthy Volunteers? Accepts Healthy Volunteers Indicates whether people who do not have the condition/disease being studied can participate in the clinical study. Healthy volunteers play an important role in research because they help define "normal" ranges. While they may receive no direct benefit, healthy volunteers choose to participate in clinical research because they want to help others and contribute to advancing science.	No

Inclusion CriteriaSubjects must meet all of the following criteria:

1 For the preterm cohort (excluding subjects with CLD or hemodynamically significant CHD): preterm infants in their first year of life and born ≤ 35 weeks 0 days GA eligible to receive palivizumab in accordance with national or local guidelines, including those with: (a) Uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, or

(b) Aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone

2 For the CLD/CHD cohort:

(a) Subjects with CLD - infants in their first year of life and a diagnosis of CLD of prematurity requiring medical intervention/management (ie, supplemental oxygen, bronchodilators, or diuretics) within the 6 months prior to randomization

(b) Subjects with CHD - infants in their first year of life and documented, hemodynamically significant CHD (must be unoperated or partially corrected CHD) Note: Infants with hemodynamically significant acyanotic cardiac lesions must have pulmonary hypertension (≥ 40 mmHg measured pressure in the pulmonary artery) or the need for daily medication to manage CHD

3 Infants who are entering their first RSV season at the time of screening

4 Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the USA, EU Data Privacy Directive in the EU) obtained from the subject's parent(s)/legal representative(s) prior to performing any protocol-related procedures, including screening evaluations

5 Subject's parent(s)/legal representative(s) able to understand and comply with the requirements of the protocol including follow-up and illness visits as judged by the investigator

6 Subject is available to complete the follow-up period, which will be 1 year after Season 1/ Dose 1 for subjects without CLD/CHD, or 1 year after Season 2/Dose 1 (or last replacement dose as applicable for CHD) for subjects with CLD/CHD

Exclusion CriteriaAny of the following would exclude the subject from participation in the study:

1 Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to randomization

2 Any history of LRTI or active LRTI prior to, or at the time of, randomization

3 Known history of RSV infection or active RSV infection prior to, or at the time of, randomization

4 Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization

5 Requirement for mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or other mechanical respiratory or cardiac support at the time of randomization

6 Anticipated cardiac surgery within 2 weeks after randomization

7 Anticipated survival of

8 Receipt of any investigational drug

9 Known renal impairment

10 Known hepatic dysfunction including known or suspected active or chronic hepatitis infection

11 Clinically significant congenital anomaly of the respiratory tract

12 Chronic seizure, or evolving or unstable neurologic disorder

13 Prior history of a suspected or actual acute life-threatening event

14 Known immunodeficiency, including human immunodeficiency virus (HIV)

15 Mother with HIV infection (unless the child has been proven to be not infected)

16 Any known allergy, including to immunoglobulin products, or history of allergic reaction

17 Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination

18 Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study

19 Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results

20 Concurrent enrollment in another interventional study

21 Children of employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals

Categories Click category to view its trials.

Lungs/Breathing

Pediatrics

Women's Health

Participating Locations

Children’s of Mississippi Hospital - Blair E. Batson Tower

Grants Ferry - UMMC

Jackson Medical Mall (Children’s Clinics) - UMMC

Pavilion - UMMC

University Physicians - UMMC

Contact Information