An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults
NCT ID: NCT01018641
Last Updated: 2014-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
449 participants
INTERVENTIONAL
2010-01-31
2011-07-31
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
TRIPLE
Study Groups
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1
SA3Ag in both stage 1 and stage 2
SA3Ag vaccine
In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:
Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm
In stage 2 the subject will receive 0.5 mL IM of the same dose level he/she received in stage 1.
Blood draw
Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
2
SA3Ag in stage 1 followed by placebo in stage 2.
SA3Ag followed by Placebo
In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:
Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm
In stage 2 the subject will receive one injection of 0.5 mL IM of the placebo.
Blood draw
Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
3
Placebo in both stage 1 and stage 2
Placebo
In both stage 1 and stage 2, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl for a total of 2 injections throughout the study.
Blood draw
Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
4
SA3Ag in stage 1 and no vaccine in stage 2.
SA3Ag with no booster in stage 2
In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:
Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm
In stage 2 the subject will receive no vaccine.
Blood draw
Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
5
Placebo in stage 1 and no vaccine in stage 2.
Placebo with no booster in stage 2
In stage 1, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl.
In stage 2 the subject will receive no vaccine.
Blood draw
Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
Interventions
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SA3Ag vaccine
In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:
Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm
In stage 2 the subject will receive 0.5 mL IM of the same dose level he/she received in stage 1.
Blood draw
Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
SA3Ag followed by Placebo
In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:
Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm
In stage 2 the subject will receive one injection of 0.5 mL IM of the placebo.
Blood draw
Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
Placebo
In both stage 1 and stage 2, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl for a total of 2 injections throughout the study.
Blood draw
Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
SA3Ag with no booster in stage 2
In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:
Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm
In stage 2 the subject will receive no vaccine.
Blood draw
Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
Placebo with no booster in stage 2
In stage 1, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl.
In stage 2 the subject will receive no vaccine.
Blood draw
Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
Eligibility Criteria
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Inclusion Criteria
* Men and women who are able to have children, must use a reliable method of birth control for the duration of the study.
Exclusion Criteria
* Donation of 250 mL or more of blood within the last 3 months.
* Condition associated with prolonged bleeding time, including subjects taking anticoagulant medication or antiplatelet therapy.
* Any contraindication to vaccination or vaccine components.
* Immunocompromised persons and subjects who receive treatment with immunosuppressive therapy.
* Previous administration of S. aureus vaccination.
* Receipt of blood products or immunoglobulins within 12 months prior to study
* Participation in another trial (not including observational trials) within the last 30 days.
* Study site personnel or immediate family members (first-degree relatives).
* Women who are pregnant (as determined by urine pregnancy test) or breast-feeding.
* Residence in a nursing home or long-term care facility or requirement for semiskilled nursing care.
* For subjects aged 65 years or older, a Mini-Mental State Examination (MMSE) score of \<=21.
18 Years
85 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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Pfizer Investigational Site
Herston, Queensland, Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia
Pfizer Investigational Site
North Adelaide, South Australia, Australia
Pfizer Investigational Site
Prahran, Victoria, Australia
Pfizer Investigational Site
Subiaco, Western Australia, Australia
Countries
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References
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Marshall H, Nissen M, Richmond P, Shakib S, Jiang Q, Cooper D, Rill D, Baber J, Eiden J, Gruber WC, Jansen KU, Anderson AS, Zito ET, Girgenti D. Safety and immunogenicity of a booster dose of a 3-antigen Staphylococcus aureus vaccine (SA3Ag) in healthy adults: A randomized phase 1 study. J Infect. 2016 Nov;73(5):437-454. doi: 10.1016/j.jinf.2016.08.004. Epub 2016 Aug 9.
Nissen M, Marshall H, Richmond P, Shakib S, Jiang Q, Cooper D, Rill D, Baber J, Eiden J, Gruber W, Jansen KU, Emini EA, Anderson AS, Zito ET, Girgenti D. A randomized phase I study of the safety and immunogenicity of three ascending dose levels of a 3-antigen Staphylococcus aureus vaccine (SA3Ag) in healthy adults. Vaccine. 2015 Apr 8;33(15):1846-54. doi: 10.1016/j.vaccine.2015.02.024. Epub 2015 Feb 21.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B2251002
Identifier Type: -
Identifier Source: secondary_id
6123K1-1007
Identifier Type: -
Identifier Source: org_study_id
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