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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 June 2013
• Main ID: NCT01475305
• Date of registration: 14/10/2011
• Primary sponsor: MedImmune LLC
• Public title: Intra-nasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV)
• Scientific 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)
• Date of first enrolment: November 2011
• Target sample size: 7
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01475305
• 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

Countries of recruitment

United Kingdom

Contacts

• Name: Hasan Jafri, MD
• Affiliation: MedImmune LLC

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

RSV Infection

Intervention(s)

Drug: MEDI-557

Other: Placebo

Primary Outcome(s)

Incidence of RSV infection [Time Frame: Up to 12 days post-RSV challenge]

Secondary Outcome(s)

Additional efficacy measured by incidence and viral load of RSV infection [Time Frame: Through Study Day 31]

Clinical lab measurements [Time Frame: Through Study Day 91]

Occurrence of anti-MEDI-557 antibody [Time Frame: Through Study Day 360]

Pharmacokinetic assessments [Time Frame: Through Study Day 360]

The occurrence of AEs and SAEs [Time Frame: Through Study Day 360]

Vital signs [Time Frame: Through Study Day 31]

Secondary ID(s)

CD-ID-MEDI-557-1090

Source(s) of Monetary Support

Please refer to primary and secondary sponsors