A Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults

A phase 1a, first time in human, double-blind, randomized, placebo-controlled, cohort
escalation study evaluating the safety and tolerability of a single ascending intramuscular
dose of RSV sF or MEDI7510 or placebo.

Approximately 144 subjects will be enrolled at 3 US study centers and randomized in a 5:1
ratio by cohort to receive a single dose of either RSV sF or placebo or MEDI7510 on Day 1.

Cohort 1: RSV sF formulation 1 (n=20) or placebo (n=4) Cohort 1a: MEDI7510 formulation 1
(n=20) or placebo (n=4) Cohort 2: RSV sF (n=20) formulation 2 or placebo (n=4) Cohort 2a:
MEDI7510 (n=20) formulation 2 or placebo (n=4) Cohort 3: RSV sF (n=20) formulation 3 or
placebo (n=4) Cohort 3a: MEDI7510 (n=20) formulation 3 or placebo (n=4)

Inclusion Criteria:

:-Age greater than or equal to 60 years

- Written informed consent and any locally required authorization obtained prior to any
protocol related procedures

- Ambulatory or ambulatory with assistance (not institutionalized, bedridden, or
homebound

- Weight at or above 110 lbs

- Hemoglobin within normal range for age and gender -Subject available by telephone

- Subject able to understand and comply with the requirements of the protocol, as
judged by the investigator

- Subject able to complete follow-up period of 360 days after dosing

Exclusion Criteria:

- History of allergy to any component of the vaccine

- Pregnancy or potential to become pregnant during the study. Females who have had a
menstrual period within the 12 months prior to study enrollment or are undergoing any
fertility treatment or who plan to undergo fertility treatments during the study
period are excluded

- Any unstable chronic medical condition, including one that has resulted in change in
therapy (medication or other) in the 30 days prior to randomization or
hospitalization in the previous year or might be predicted to result in
hospitalization in the year after enrollment. Subjects with severe, untreated or
uncontrolled underlying medical disease that might either compromise subject safety
or affect the ability to assess safety of the investigational product are excluded

- Clinically significant abnormalities in screening laboratory assessments or screening
ECG

- History of hepatitis B or hepatitis C infection

- Cognitive disorder such that informed consent cannot be obtained directly from the
subject

- Previous vaccination against RSV

- History of allergy to eggs in adulthood

- History of or current autoimmune disorder

- Immunosuppression caused by disease, including HIV, or medications. Any oral
prednisone dosing within 30 days of enrollment or planned dosing within the 360-day
follow-up period would disqualify.

- History of splenectomy or of condition affecting splenic function

- History of cancer within preceding 5 years other than treated non-melanoma skin
cancer

- Body Mass Index 40 or higher

- Significant infection or other acute illness, including fever over 100 F on the day
prior to or day of randomization

- Receipt of any nonstudy vaccine within 30 days prior to study dosing or expected
receipt of nonstudy vaccine within 30 days after study dosing

- Receipt of any investigational product in the 90 days prior to randomization or
expected receipt of investigational product during the period of study follow-up

- Receipt of immunoglobulins or blood products within 4 months of study dosing (120
days) or expected receipt of investigational product during the period of study
follow-up History of thrombocytopenia or bleeding disorder or use of anticoagulants.
Subjects receiving drugs with anti-platelet activity such as nonsteroidal
antiinflammatory drugs, clopidogrel or aspirin are not excluded

- Expected receipt of antipyretic or analgesic medication on a daily or every other day
basis from randomization through 72 hours after receipt of IP (a daily dose of 163 mg
or higher is not considered a contraindication to enrollment)

- Subjects who have significant scarring, tattoos, abrasions, cuts, or infections over
the deltoid region of both arms that, in the PI's opinion, could interfere with
evaluation of injection site local reactions

- Any condition that, in the PI's opinion, would interfere with evaluation of the IP or
interpretation of subject safety or study results

- Concurrent enrollment in another clinical study that involves any invasive clinical
procedure, including phlebotomy

- History of alcohol or drug abuse or psychiatric disorder that in the PI's opinion
would affect the subject's safety or compliance with study

- Employees of individuals directly involved with the conduct of the study, individuals
who themselves are involved with the conduct of the study, or immediate family
members of such individuals.