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
NCT ID: NCT01364571
Last Updated: 2019-03-04
Study Results
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Basic Information
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COMPLETED
PHASE1
456 participants
INTERVENTIONAL
2011-08-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
SA4Ag vaccine low dose
SA4Ag vaccine low dose
Subjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine.
Blood draw
Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab sample
Colonization swabs will be collected from all subjects at various time points throughout the study.
2
SA4Ag vaccine mid dose
SA4Ag vaccine mid dose
Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine.
Blood sample
Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab sample
Colonization swabs will be collected from all subjects at various time points throughout the study.
3
SA4Ag vaccine high dose
SA4Ag vaccine high dose
Subjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine.
Blood draw
Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab sample
Colonization swabs will be collected from all subjects at various time points throughout the study.
4
Placebo
Placebo
Subjects receive one intramuscular injection (0.5 mL) of commercially available normal saline.
Blood draw
Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab sample
Colonization swabs will be collected from all subjects at various time points throughout the study.
Interventions
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SA4Ag vaccine low dose
Subjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine.
Blood draw
Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab sample
Colonization swabs will be collected from all subjects at various time points throughout the study.
SA4Ag vaccine mid dose
Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine.
Blood sample
Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab sample
Colonization swabs will be collected from all subjects at various time points throughout the study.
SA4Ag vaccine high dose
Subjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine.
Blood draw
Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab sample
Colonization swabs will be collected from all subjects at various time points throughout the study.
Placebo
Subjects receive one intramuscular injection (0.5 mL) of commercially available normal saline.
Blood draw
Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab sample
Colonization swabs will be collected from all subjects at various time points throughout the study.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
64 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Broward Research Group
Hollywood, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States
SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, United States
Prism Research
Saint Paul, Minnesota, United States
Buffalo Clinical Research Center, LLC
Buffalo, New York, United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
Cary, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
Volunteer Research Group
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Benchmark Research
Austin, Texas, United States
Roberta Braun, M.D.
Austin, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
Countries
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References
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Creech CB, Frenck RW, Fiquet A, Feldman R, Kankam MK, Pathirana S, Baber J, Radley D, Cooper D, Eiden J, Gruber WC, Jansen KU, Anderson AS, Gurtman A. Persistence of Immune Responses Through 36 Months in Healthy Adults After Vaccination With a Novel Staphylococcus aureus 4-Antigen Vaccine (SA4Ag). Open Forum Infect Dis. 2019 Dec 24;7(1):ofz532. doi: 10.1093/ofid/ofz532. eCollection 2020 Jan.
Frenck RW Jr, Creech CB, Sheldon EA, Seiden DJ, Kankam MK, Baber J, Zito E, Hubler R, Eiden J, Severs JM, Sebastian S, Nanra J, Jansen KU, Gruber WC, Anderson AS, Girgenti D. Safety, tolerability, and immunogenicity of a 4-antigen Staphylococcus aureus vaccine (SA4Ag): Results from a first-in-human randomised, placebo-controlled phase 1/2 study. Vaccine. 2017 Jan 5;35(2):375-384. doi: 10.1016/j.vaccine.2016.11.010. Epub 2016 Dec 1.
Other Identifiers
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6123K1-1005
Identifier Type: OTHER
Identifier Source: secondary_id
B3451001
Identifier Type: -
Identifier Source: org_study_id
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