Status:
TERMINATED
Intranasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV)
Lead Sponsor:
MedImmune LLC
Conditions:
RSV Infection
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The primary objective is to evaluate the suitability of the challenge model in measuring the efficacy of MEDI-557 compared to placebo in healthy adult participants for the reduction in the incidence o...
Detailed Description
This is designed to be a double-blind, placebo-controlled, randomized study. Approximately 30 participants will be randomized, dosed and followed. Participants will be randomly assigned to receive a s...
Eligibility Criteria
Inclusion
- Healthy as determined by medical history and physical examination.
- Age 19 through 38 years at the time of screening.
- Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Weight less than or equal to (\<=) 10 kilogram (kg) with body mass index (BMI) less than (\<) 32 kilogram per meter square (kg/m\^2).
- Normotensive (systolic blood pressure \[BP\] \<150 millimeters of mercury (mmHg) and diastolic BP \< 90 mmHg).
- Females of childbearing age using contraception.
- Males who are sexually active with a female partner of childbearing potential, using contraception.
- Sero-suitable (that is, low serum RSV neutralizing antibody titre) for RSV infection.
Exclusion
- Current medical conditions as follows:
- Clinical evidence of chronic pulmonary disease or any use of a bronchodilator or other asthma medication.
- Current smoker unwilling/unable to desist for the quarantine phase of the study.
- History or clinical evidence of recurrent lower respiratory tract infection.
- Evidence of infection with hepatitis A, B, or C virus or human immunodeficiency virus (HIV) by serology.
- Medical history as follows:
- History of immunodeficiency.
- History of chronic sinusitis.
- History of frequent epistaxis.
- History of or current diagnosis of diabetes.
- 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.
- Nursing mother.
- Alcohol or drug addiction/abuse within the past 2 years.
- A positive urine Class A drug or alcohol screen unless there is a medical reason.
- History of seasonal hay fever or seasonal allergies.
- 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.
- Health care workers anticipated to have patient contact within 2 weeks after viral challenge.
- Participants 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).
- As a result of the medical interview, physical examination, or screening investigations, the investigator(s) considers the participant unfit for the study.
Key Trial Info
Start Date :
October 20 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01475305
Start Date
October 20 2011
End Date
December 13 2012
Last Update
July 21 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
London, United Kingdom, E1 2AX