Intra-nasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01475305
First received: October 14, 2011
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

The primary goal is to evaluate the suitability of the Respiratory Syncytial Virus (RSV) challenge model in measuring the efficacy of MEDI-557 compared to placebo in healthy adult subjects for the reduction in the incidence of RSV through 12 days post-RSV challenge with the RSV virus.


Condition Intervention Phase
RSV Infection
Drug: MEDI-557
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 1 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of MEDI-557 in Healthy Adults Intranasally Challenged With Respiratory Syncytial Virus (RSV)

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Incidence of RSV infection [ Time Frame: Up to 12 days post-RSV challenge ] [ Designated as safety issue: No ]
    Measured by positive RSV assay


Secondary Outcome Measures:
  • Additional efficacy measured by incidence and viral load of RSV infection [ Time Frame: Through Study Day 31 ] [ Designated as safety issue: No ]
    Measured by positive RSV assays

  • The occurrence of AEs and SAEs [ Time Frame: Through Study Day 360 ] [ Designated as safety issue: Yes ]
    Side effects

  • Pharmacokinetic assessments [ Time Frame: Through Study Day 360 ] [ Designated as safety issue: No ]
    Blood and nasal samples

  • Occurrence of anti-MEDI-557 antibody [ Time Frame: Through Study Day 360 ] [ Designated as safety issue: Yes ]
    Blood samples

  • Vital signs [ Time Frame: Through Study Day 31 ] [ Designated as safety issue: Yes ]
    blood pressure, heart rate, respiratory rate, temperature

  • Clinical lab measurements [ Time Frame: Through Study Day 91 ] [ Designated as safety issue: Yes ]
    Chemistry, Hematology, Coagulation, Cardiac enzymes


Enrollment: 7
Study Start Date: November 2011
Study Completion Date: April 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI-557
Up to 15 subjects
Drug: MEDI-557
Recombinant humanized immunoglobulin G (IgG)1kappa monoclonal antibody
Placebo Comparator: Placebo
Up to 15 subjects
Other: Placebo
Placebo

Detailed Description:

This is designed to be a double-blind, placebo-controlled, randomized study. Up to 30 subjects will be randomized, dosed and followed. Subjects will be randomly assigned to receive a single intravenous (IV) dose of MEDI-557 or placebo. Subjects will be inoculated with RSV. Subjects will be followed for efficacy for 12 days post-RSV challenge. Safety follow-up will be approximately 12 months from randomization.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy as determined by medical history and physical examination.
  2. Age 18 through 45 years at the time of screening.
  3. Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
  4. Weight ≤110 kg with body mass index (BMI) < 32 kg/m2.
  5. Normotensive (systolic blood pressure [BP] <150 mmHg and diastolic BP < 90 mmHg).
  6. Females of childbearing age using contraception.
  7. Males who are sexually active with a female partner of childbearing potential, using contraception.

Exclusion Criteria:

Current medical conditions as follows:

  1. Clinical evidence of chronic pulmonary disease or any use of a bronchodilator or other asthma medication.
  2. Current smoker unwilling/unable to desist for the quarantine phase of the study
  3. History or clinical evidence of recurrent lower respiratory tract infection
  4. Evidence of infection with hepatitis A, B, or C virus or human immunodeficiency virus (HIV) by serology.

Medical history as follows:

5) History of immunodeficiency. 6) History of chronic sinusitis. 7) Prior/concomitant therapy including

  • Receipt of any systemic chemotherapeutic agent at any time;
  • Receipt of systemic glucocorticoids within 1 month, or any other immunosuppressive drug within 6 months prior to challenge.
  • Receipt of any investigational drug within 6 months prior to dose or concurrent enrolment in another clinical study.
  • Prior participation in a clinical trial of any experimental RSV viral challenge delivered directly to the respiratory tract at any time, or any other respiratory virus challenge within 1 year prior to dose. 8) Nursing mother. 9) Alcohol or drug addiction/abuse within the past 2 years. 10) A positive urine Class A drug or alcohol screen unless there is a medical reason 11) History of seasonal hay fever or seasonal allergies 12) Employees of the clinical study site or sponsor, any other individuals involved with the conduct of the study, or immediate family members of such individuals. 13) Health care workers anticipated to have patient contact within 2 weeks after viral challenge. 14) Subjects who, for an additional 2 weeks after discharge from the isolation facility, are likely to have contact with a household member or close contact with someone who is: (a) less than 3 years of age; (b) any person with any known immunodeficiency; (c) any person receiving immunosuppressant medications; (d) any person undergoing or soon to undergo cancer chemotherapy within 28 days of challenge; (e) any person who has diagnosed emphysema or COPD, is elderly residing in a nursing home, or with severe lung disease or medical condition; or (f) any person who has received a transplant (bone marrow or solid organ). 15) As a result of the medical interview, physical examination, or screening investigations, the investigator(s) considers the subject unfit for the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475305

Locations
United Kingdom
Research Site
London, United Kingdom, E1 2AX
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Hasan Jafri, MD MedImmune LLC
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01475305     History of Changes
Other Study ID Numbers: CD-ID-MEDI-557-1090
Study First Received: October 14, 2011
Last Updated: June 5, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by MedImmune LLC:
RSV, Healthy adults, MEDI-557, intranasal challenge, human model

Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 16, 2014