RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults

Inclusion Criteria (Main study):

1. Male and female subjects, ≥ 55 years of age.

2. Prior to performance of any trial specific procedures, the subject has read, signed
and dated an informed consent form, having been advised of the risks and benefits of
the trial in a language understood by the subject, and has signed the Health Insurance
Portability and Accountability Act (HIPAA) authorization form.

3. Subjects without symptomatic cardiopulmonary and/or metabolic disease. Note that
subjects who have any active symptoms related to cardiac and/or pulmonary and/or
metabolic disease (including e.g. uncontrolled asthma, angina pectoris, hyperglycaemia
or other episodic symptoms), or who receive ongoing therapy to control current, active
symptoms, are not eligible. Subjects on stable treatment (no change in ≥ 1 month) for
previous and controlled symptoms or conditions are eligible. The following are
examples of subjects who may bear cardiopulmonary or metabolic diagnoses but who would
remain eligible:

- Subjects on stable (no change in ≥ 1 month) therapy for findings (e.g.
hypertension, hyperlipidemia) which are not associated with current symptoms or
disability.

- Subjects with type II diabetes mellitus are considered eligible as long as they
are stable on oral antidiabetics and have either a documented glycated hemoglobin
(HbA1c) of ≤ 8 % within three months prior to trial participation or confirmation
of controlled blood glucose level must be obtained at the SCR (screening) visit
by a lab test.

- Subjects who receive short term treatment for temporary conditions.

- Other clinically insignificant findings not deemed to be associated with
increased risk for respiratory viral infections as determined by the
investigator.

4. Able to comply with trial requirements; including access to transportation for trial
visits.

5. Body mass index (BMI) ≥ 18.5 and ≤ 39.9

BMI formula for pounds and inches:

BMI = (bodyweight in pounds) * 703 (bodyheight in inches)2

6. Women of childbearing potential (WOCBP) must have used an acceptable method of
contraception for at least 30 days prior to the first vaccination, must agree to use
an acceptable method of contraception (as defined in Section 8.2.11) during the trial,
and must avoid becoming pregnant for at least 28 days after the last vaccination.
WOCBP must have a negative serum pregnancy test at screening and a negative urine
pregnancy test prior to each vaccination

7. Not clinically significant laboratory values as defined in the protocol, excluding any
Grade ≥ 3 toxicity.

8. Negative human immunodeficiency virus antibody test (anti-HIV), negative hepatitis B
surface antigen (HBsAG) and negative antibody test to hepatitis C virus.

9. Electrocardiogram (ECG) without clinically significant acute findings (e.g. findings
suggestive of current ischemia, ventricular arrhythmias, congestive heart failure and
ventricular hypertrophy).

Exclusion Criteria (Main Study):

1. Pregnant or breast-feeding women.

2. Uncontrolled serious infection, i.e. not responding to antimicrobial therapy.

3. History or current clinical manifestation of any serious medical condition, which in
the opinion of the investigator would compromise the safety of the subject or would
limit the subject's ability to complete the trial.

- History of cerebrovascular disorders, including stroke. Patients with history of
transient ischaemic attack (TIA) ≥ 1 year prior to trial participation remain
eligible.

- History of myocardial infarction within ≤ 1 year prior to trial participation,
current clinical manifestation of angina pectoris, current clinical manifestation
of congestive heart failure ≥ New York Heart Association (NYHA) Grade II,
uncontrolled high blood pressure defined as systolic blood pressure ≥ 150 mmHg
and/or diastolic ≥ 100 mmHg within the last 2 months.

4. History of or active autoimmune disease. Persons with vitiligo or thyroid disease
taking thyroid replacement are not excluded. Persons with rheumatoid arthritis not
requiring immunomodulatory and/or immunosuppressant treatment are not excluded.

5. Known or suspected impairment of immunologic functions including, but not limited to
chronic inflammatory bowel disorders, diabetes mellitus type I.

6. History of malignancy other than squamous cell or basal cell skin cancer, unless there
has been surgical excision at least 6 months ago that is considered to have achieved
cure. Subjects with history of skin cancer should not be vaccinated at the previous
tumor site.

7. Clinically significant mental disorder, not adequately controlled by medical
treatment.

8. Active or recent (within the time period of six months before trial participation)
history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse.

9. History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine, e.g. tris(hydroxymethyl)-amino methane, chicken embryo fibroblast
proteins, gentamycin.

10. Known allergy to eggs or aminoglycosides.

11. History of anaphylaxis or severe allergic reaction to any vaccine.

12. Having received any vaccinations or planned vaccinations with a live vaccine within 30
days prior to or after trial vaccination.

13. Having received any vaccinations or planned vaccinations with an inactivated vaccine
within 14 days prior to or after trial vaccination.

14. Chronic systemic administration (defined as more than 14 days) of > 5 mg prednisone
(or equivalent)/day or any other immune-modifying drugs during a period starting from
three months prior to first administration of the trial vaccination and ending at the
last visit of the active trial phase. The use of topical, inhaled, ophthalmic and
nasal glucocorticoids is permitted.

15. Administration or planned administration of immunoglobulins and/or any blood products
during a period starting from three months prior to first administration of the trial
vaccination and ending at the last visit of the active trial phase.

16. Use of any investigational or non-registered drug or vaccine other than the trial
vaccine within 30 days preceding the first trial vaccination, or planned
administration of such a drug between participation in the trial and until 4 weeks
after last trial vaccination.

17. Previous or planned vaccination with a RSV vaccine/vaccine candidate.

18. Clinical trial personnel working on the current trial.

Inclusion Criteria (Substudy):

1. Prior to performance of any booster substudy specific procedures, the subject has
read, signed and dated an informed consent form, having been advised of the risks and
benefits of the trial in a language understood by the subject.

2. Subject has completed all vaccinations of the main trial according to protocol.

Exclusion Criteria (Substudy):

1. Any condition that, in the opinion of the investigator, makes it unsafe for the
subject to receive a further vaccination.

2. Pregnancy.

3. An anaphylactic reaction following the administration of any vaccine(s).

4. Clinical need for concomitant or ancillary therapy not permitted in the trial as
outlined in Protocol Section 8.2.2.

5. Having received any vaccinations or planned vaccinations with a live vaccine within 30
days prior to or after booster vaccination.

6. Having received any vaccinations or planned vaccinations with an inactivated vaccine
within 14 days prior to or after booster vaccination.

7. Chronic systemic administration (defined as more than 14 days) of > 5 mg prednisone
(or equivalent)/day or any other immune-modifying drugs during a period starting from
3 months prior to administration of the booster vaccine and ending at the last visit
of the booster active trial phase. The use of topical, inhaled, ophthalmic and nasal
glucocorticoids is permitted.

8. Administration or planned administration of immunoglobulins and/or any blood products
during a period starting from 3 months prior to administration of the booster vaccine
and ending at the last visit of the booster active trial phase.

9. Use of any investigational or non-registered drug or vaccine other than the trial
vaccine within 30 days preceding the booster vaccination, or planned administration of
such a drug during participation in the booster substudy and until 4 weeks after
booster vaccination.

10. Subject's request to discontinue

11. Subject's refusal to receive booster vaccination.

12. Subject unwilling or unable to comply with trial requirements. Any reason that, in the
opinion of the investigator contradicts administration of the booster vaccination or
otherwise requires early discontinuation of a subject.