RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness
NCT ID: NCT00632463
Last Updated: 2013-04-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
21 participants
INTERVENTIONAL
2008-02-29
2010-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in Adults 18 to 50 Years of Age, and RSV-seropositive Toddlers 12 to 24 Months of Age
NCT03303625
A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older
NCT03982199
A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults
NCT06067230
A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Adults at High Risk of Severe RSV Disease
NCT05842967
Challenge Infection of Healthy Adult Volunteers With RSV A2
NCT03388645
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Dose regimen 1
RI-001
Dose 1
2
Dose regimen 2
RI-001
Dose 2
3
Placebo
RI-001
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RI-001
Dose 1
RI-001
Dose 2
RI-001
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
2 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ADMA Biologics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Upton Allen, MBBS
Role: PRINCIPAL_INVESTIGATOR
Division of Infectious Diseases, Hospital for Sick Children, Toronto, Ontario, Canada
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California San Francisco
San Francisco, California, United States
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
All Children's Hospital
St. Petersburg, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Johns Hopkins Medical Center
Baltimore, Maryland, United States
New England Medical Center
Boston, Massachusetts, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Schneider Children's Hospital
New Hyde Park, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Seattle Children's Hospital and Regional Medical Center
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Alberta Children's Hospital
Calgary, Alberta, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ADMA-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.