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| ID | Type | Description | Link |
|---|---|---|---|
| B2251002 |
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This study is a first-in-human (Phase 1) study using three dose levels of an investigational vaccine directed against Staphylococcus aureus (SA3Ag). This study is primarily designed to assess how safe and well tolerated SA3Ag is, but will also describe the immune response over 12 months elicited by SA3Ag. Additionally, this study will assess the effect of SA3Ag vaccine on the number of Staphylococcus aureus bacteria that naturally occur on the skin and within the nose and throat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | SA3Ag in both stage 1 and stage 2 |
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| 2 | Experimental | SA3Ag in stage 1 followed by placebo in stage 2. |
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| 3 | Placebo Comparator | Placebo in both stage 1 and stage 2 |
|
| 4 | Experimental | SA3Ag in stage 1 and no vaccine in stage 2. |
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| 5 | Placebo Comparator | Placebo in stage 1 and no vaccine in stage 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SA3Ag vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary immunogenicity endpoint in stage 1 is antigen-specific antibody levels using an Ig binding assay (Ig titers) 28 days after vaccination at visit 1 in the 50- to 85-year age stratum at each vaccine group (3 SA3Ag dose levels and placebo). | 1 month | |
| The primary comparison of interest is a 2-fold increase in Ig titers relative to baseline for each antigen. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary immunogenicity endpoints are Ig titers for each antigen (CP5, CP8, and rClfAm) 28 days after vaccination in the 18- to 24-year age stratum at each dose level cohort. | 1 month | |
| Ig titers for each antigen 28 days after the booster dose. | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Herston | Queensland | 4029 | Australia | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27519620 | Derived | 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. | |
| 25707693 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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|
| Blood draw | Procedure | 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 | Procedure | Colonization swabs will be taken at timepoints throughout stage 1 and stage 2. |
|
| SA3Ag followed by Placebo | Biological | 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 | Procedure | 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 | Procedure | Colonization swabs will be taken at timepoints throughout stage 1 and stage 2. |
|
| Placebo | Biological | 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 | Procedure | 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 | Procedure | Colonization swabs will be taken at timepoints throughout stage 1 and stage 2. |
|
| SA3Ag with no booster in stage 2 | Biological | 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 | Procedure | 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 | Procedure | Colonization swabs will be taken at timepoints throughout stage 1 and stage 2. |
|
| Placebo with no booster in stage 2 | Procedure | 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 | Procedure | 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 | Procedure | Colonization swabs will be taken at timepoints throughout stage 1 and stage 2. |
|
| The safety endpoints are solicited and unsolicited AEs, SAEs, and hematologic and urine parameters. | 12 months |
| OPA titers for each antigen 28 days after vaccination in both age strata at selected dose level cohort(s). | 1 month |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| Pfizer Investigational Site | North Adelaide | South Australia | 5006 | Australia |
| Pfizer Investigational Site | Prahran | Victoria | 3004 | Australia |
| Pfizer Investigational Site | Subiaco | Western Australia | 6008 | Australia |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D009043 | Motor Activity |
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001519 | Behavior |
| D016908 | Gram-Positive Bacterial Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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