A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

Status:Not yet recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Age Range:60 - 85
Start Date:March 11, 2019
End Date:May 25, 2022
Contact:Study Contact

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A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

The purpose of this study is to evaluate the safety and reactogenicity of three doses of
VAC52416 (ExPEC10V) and to evaluate the dose‑dependent immunogenicity of ExPEC10V as measured
by enzyme-linked immunosorbent assay (ELISA) and opsonophagocytic killing assay (OPA) on Day
15 in participants greater than equal to 60 to less than equal to 85 years of age.

Inclusion Criteria:

- Must have a body mass index (BMI) of greater than (>) 18.5 or less than equal to (<=)
35 kilogram per meter square (kg/m^2)

- Before randomization, a woman must be: postmenopausal - A postmenopausal state is
defined as no menses for 12 months without an alternative medical cause; or not
intending to conceive by any methods

- Must be healthy or medically stable

- Must sign an informed consent form (ICF) indicating that he or she understands the
purpose of, and procedures required for, the study and is willing to participate in
the study

- Willing and able to adhere to the lifestyle restrictions specified in this protocol

- Agrees not to donate blood until 12 weeks after receiving the study intervention

Exclusion Criteria:

- Acute illness (this does not include minor illnesses such as diarrhea or mild upper
respiratory tract infection) or temperature greater than equal to >=38.0 degree
Celsius (100.4 degree Fahrenheit) within 24 hours prior to the administration of study
intervention; enrollment at a later date is permitted (provided the screening window
of 28 days is respected)

- History of malignancy within 5 years before screening (exceptions are squamous and
basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy,
which is considered cured with minimal risk of recurrence)

- Known allergies, hypersensitivity, or intolerance to ExPEC10V or its excipients

- Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines
or vaccine products (including any of the constituents of the active control vaccines)

- Contraindication to intramuscular (IM) injections and blood draws example, bleeding

- Abnormal function of the immune system

- Has had major psychiatric illness and/or drug substance or alcohol abuse in the past
12 months
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Rochester, NY
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