RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness

RSV infections can develop into serious, life threatening conditions among immunocompromised patients. The objective of this study (ADMA 001) is to evaluate the safety and efficacy of RI-001 for the prevention of lower respiratory tract infections in immunocompromised patients identified as being infected with RSV in the upper respiratory tract.

Study Overview

• Status: Completed
• Conditions: Lower Respiratory Tract Infection; Upper Respiratory Tract Infection
• Intervention / Treatment: Biological: RI-001; Biological: RI-001; Biological: RI-001

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B6A8
      • Alberta Children's Hospital
  • Ontario
    • Toronto, Ontario, Canada, M5G1X8
      • Hospital for Sick Children
  • Quebec
    • Montreal, Quebec, Canada, H1T2M4
      • Hopital Maisonneuve Rosemont
    • Montreal, Quebec, Canada, H3T1C5
      • Hôpital Sainte Justine
• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health Sciences Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Florida
    • St. Petersburg, Florida, United States, 33701
      • All Children's Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • New England Medical Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New Hyde Park, New York, United States, 11040
      • Schneider Children's Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center of Dallas
    • Fort Worth, Texas, United States, 76104
      • Cook Children's Medical Center
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital and Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. An IEC/IRB approved written informed consent signed and dated by the patient or by parent(s) or a legally acceptable representative. The consent form or a specific assent form, where required, will be signed and dated by minors.
2. Documented Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT), Pulmonary/Cardiac Transplant, Pulmonary Transplant or Liver Transplant within the 2 years prior to randomization to the study drug.
3. Male/Female patients age: (Pediatric) ≥2 years and <16 years at the time of informed consent.
4. Male/Female patients age: (Adult) ≥ 16 years and ≤ 65 years at the time of informed consent.
5. Patient must have an URTI as defined by Respiratory Assessment Score (RAS)=1.
6. Patients must be actively taking at least one immunosuppressive agent.
7. Patients must have a positive RSV RT-PCR at the time of the randomization procedures.
8. Female patients must be of non-childbearing potential or have a negative pregnancy test prior to study start and be deemed not at risk of becoming pregnant by adherence to a reliable contraceptive method for the duration of the study. Females of non-childbearing potential are defined as women who have had a hysterectomy, bilateral oophorectomy, tubal ligation or who have been post-menopausal for at least two years, or are considered to be sterile due to recent chemotherapy.
9. Female patients who are not breast-feeding.
10. Patient/legally acceptable representative considered as reliable and capable of adhering to the protocol (e.g. able to understand and complete diaries and questionnaires), visit schedules or treatment regimen according to the judgment of the Investigator.

Exclusion Criteria:

1. Documented RSV lower respiratory tract infection (respiratory assessment score is greater than 1) as determined by the site investigators or research staff.
2. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support
3. Unstable respiratory status so severe that survival is not expected for longer than 6 months.
4. End organ dysfunction resulting in anticipated survival of less than 6 months.
5. Known to be HIV positive.
6. Administration of any RSV specific products, including palivizumab (Synagis®) in the 3 months prior to randomization procedures.
7. Previous, current, or planned administration of an investigational RSV vaccine.
8. Known hypersensitivity to immunoglobulin.
9. Known Immunoglobulin (IgA) deficiency
10. Known renal impairment requiring any form of dialysis (HD, PD, CRRT).
11. Known hemodynamically significant congenital heart disease.
12. Previous poor compliance with visit schedules.
13. Severe medical, neurological or psychiatric disorders or laboratory values which may have an impact on the safety of the patient.
14. Concurrent participation in other investigational drug product studies; any exception must be approved by the ADMA Biologics Medical Director.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Dose regimen 1	Biological: RI-001; Dose 1; Biological: RI-001; Dose 2; Biological: RI-001; Placebo
Placebo Comparator: 3; Placebo	Biological: RI-001; Dose 1; Biological: RI-001; Dose 2; Biological: RI-001; Placebo
Experimental: 2; Dose regimen 2	Biological: RI-001; Dose 1; Biological: RI-001; Dose 2; Biological: RI-001; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating RI-001 Titer	The primary endpoint of this study was the mean fold titer increase from baseline to Day 18 in circulating serum anti-RSV neutralizing antibody following treatment with RI-001.	Study day 18

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of RSV Progression From Symptomatic Upper Respiratory Tract Infection to Lower Respiratory Tract Infection.	Study day 33
The Number of Patients Achieving at Least a 4-fold Increase in Serum RSV Neutralizing Antibody Titers	18 Days

Collaborators and Investigators

• Sponsor: ADMA Biologics, Inc.
• Investigators: Principal Investigator: Upton Allen, MBBS, Division of Infectious Diseases, Hospital for Sick Children, Toronto, Ontario, Canada

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: March 3, 2008
• First Submitted That Met QC Criteria: March 7, 2008
• First Posted (Estimate): March 10, 2008

Study Record Updates

• Last Update Posted (Estimate): April 24, 2013
• Last Update Submitted That Met QC Criteria: March 12, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Immunosuppression; Transplant
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: ADMA-001