Evaluation of a Single Vaccination With One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years



Status:Completed
Conditions:Infectious Disease, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:18 - 64
Updated:3/6/2019
Start Date:August 2011
End Date:January 2013

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A Phase 1/2 Placebo-controlled, Randomized, Double-blind Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 3 Ascending Dose Levels Of A 4-antigen Staphylococcus Aureus Vaccine (sa4ag) In Healthy Adults Aged 18 To <65 Years

This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of
three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag). The
main goal of the study is to determine how safe and well tolerated the vaccine is as well as
to describe the immune response elicited by the vaccine in healthy adults aged 18 to <65
years. In addition, the study aims to assess the effect of the SA4Ag vaccine on the presence
of the Staphylococcus aureus on the skin and within the nose, throat and perineum of healthy
adults aged 18 to <65 years.


Inclusion Criteria:

- Healthy adults aged 18 to <65 years at enrollment, as determined by medical history,
physical examination, and the clinical judgment of the investigator to be eligible for
the study. Subjects with preexisting chronic medical conditions determined to be
stable may be included.

- Availability for the entire duration of the study, and able to comply with scheduled
visits, treatment plan, laboratory tests, and other study procedures including
completion of the electronic diary (e-diary) from Day 1 to Day 14 following
vaccination(s).

- Ability to be contacted by telephone during study participation.

- All male and female subjects who are biologically capable of having children must
agree and commit to the use of a reliable method of birth control for the duration of
the study.

Exclusion Criteria:

- Unstable chronic medical condition or disease requiring significant change in therapy
or hospitalization within 3 months before receipt of study vaccine.

- Serious chronic medical disorders and any other disorder that in the investigator's
opinion precludes the subject from participating in the study

- Donation of blood volume of 250 mL or greater (excluding protocol-required blood
collection), or donation of plasma within 3 months prior to enrollment.

- Bleeding condition associated with prolonged bleeding time that may contraindicate
intramuscular injection or blood draw including subjects taking anticoagulant,
antiplatelet and/or antithrombotic agents except for low-dose daily aspirin within 30
days before enrollment through 1 month post-vaccination.

- Any contraindication to vaccination or vaccine components.

- Immunocompromised persons and subjects currently on immunosuppressive therapy or with
a history of immunosuppressive therapy, including chemotherapy agents or long term
systemic corticosteroids.

- Previous administration of S. aureus vaccination.

- Any infection proven or suspected to be caused by S. aureus within 6 months preceding
study vaccination.

- Receipt of blood products or immunoglobulins (including monoclonal antibodies) within
12 months before enrollment through conclusion of the study.

- Participation in other investigational or interventional studies within 30 days before
the current study begins and/or during study participation.

- Subjects who are investigational site staff members or subjects who are immediate
family members (1st degree relatives) of investigational site staff members or Pfizer
employees directly involved in the conduct of the trial.

- Residence in a nursing home or long-term care facility or requirement for semiskilled
nursing care.

- For Phase 1 subjects only, any abnormality in screening hematology, coagulation and/or
blood chemistry laboratory values.

- Women who are pregnant (as determined by urine pregnancy test) or breastfeeding.

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.
We found this trial at
15
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7261 Sheridan Street
Hollywood, Florida 33024
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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Austin, Texas
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Austin, Texas 78705
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Baltimore, Maryland 21201
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Bardstown, Kentucky 40004
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Buffalo, New York 14202
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Knoxville, Tennessee 37920
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Knoxville, Tennessee 37920
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Overland Park, Kansas 23112
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Saint Paul, Minnesota 55114
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