Intranasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV)
Condition: RSV Infection
MeSH terms: Respiratory Syncytial Virus Infections
Intervention: Placebo; MEDI-557
Intervention description: Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.; Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Respiratory Syncytial Virus (RSV); Healthy adults; MEDI-557; Intranasal challenge; Human model

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 of RSV through 12 days post-RSV challenge with the RSV Memphis-37 strain.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy as determined by medical history and physical examination.

          2. Age 19 through 38 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 less than or equal to (<=) 10 kilogram (kg) with body mass index (BMI) less
             than (<) 32 kilogram per meter square (kg/m^2).

          5. Normotensive (systolic blood pressure [BP] <150 millimeters of mercury (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.

          8. Sero-suitable (that is, low serum RSV neutralizing antibody titre) for RSV infection.

        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. History of frequent epistaxis.

          8. History of or current diagnosis of diabetes.

          9. 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.

         10. Nursing mother.

         11. Alcohol or drug addiction/abuse within the past 2 years.

         12. A positive urine Class A drug or alcohol screen unless there is a medical reason.

         13. History of seasonal hay fever or seasonal allergies.

         14. 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.

         15. Health care workers anticipated to have patient contact within 2 weeks after viral
             challenge.

         16. 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).

         17. As a result of the medical interview, physical examination, or screening
             investigations, the investigator(s) considers the participant unfit for the study.