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| ID | Type | Description | Link |
|---|---|---|---|
| 6123K1-1005 | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | SA4Ag vaccine low dose |
|
| 2 | Experimental | SA4Ag vaccine mid dose |
|
| 3 | Experimental | SA4Ag vaccine high dose |
|
| 4 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SA4Ag vaccine low dose | Biological | Subjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and proportion of subjects reporting local reactions (size of redness and/or swelling and severity of pain at the injection site) and severity of the local reactions as self-reported on electronic diaries (e-diaries) | 14 days | |
| Number and proportion of subjects reporting solicited systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain) and severity of solicited systemic events self-reported on electronic diaries | 14 days | |
| Number and proportion of subjects reporting unsolicited AEs and serious adverse events (SAEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA) | 1 month (AEs), 6 months (SAEs) | |
| Number and proportion of Phase 1 subjects with abnormal hematology, coagulation and blood chemistry lab assessments; number and proportion of Phase 1 subjects with grading shifts in hematology, coagulation and blood chemistry laboratory assessments. | 14 days | |
| Proportion of subjects achieving antibody responses to specific antigens with results greater than or equal to thresholds specific to each of the 4 antigens in the vaccine based on immunoglobulin-binding and/or opsonophagocytic activity assays. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Immunoglobulin concentrations for each antigen at each applicable blood sampling time point, | various, up to 12 months | |
| Opsonophagocytic activity (OPA) titers at each applicable blood sampling time point, | 1 month |
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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 |
|---|---|---|---|---|---|---|
| Broward Research Group | Hollywood | Florida | 33024 | United States | ||
| Miami Research Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31993453 | Derived | 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. | |
| 27916408 |
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| Blood draw | Procedure | 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 | Procedure | Colonization swabs will be collected from all subjects at various time points throughout the study. |
|
| SA4Ag vaccine mid dose | Biological | Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine. |
|
| Blood sample | Procedure | 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 | Procedure | Colonization swabs will be collected from all subjects at various time points throughout the study. |
|
| SA4Ag vaccine high dose | Biological | Subjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine. |
|
| Blood draw | Procedure | 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 | Procedure | Colonization swabs will be collected from all subjects at various time points throughout the study. |
|
| Placebo | Biological | Subjects receive one intramuscular injection (0.5 mL) of commercially available normal saline. |
|
| Blood draw | Procedure | 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 | Procedure | Colonization swabs will be collected from all subjects at various time points throughout the study. |
|
| Immunoglobulin geometric mean fold rise (GMFR) for each antigen | 1 month |
| Geometric mean fold rise on opsonophagocytic activity assay titers | 1 month |
| Proportion of subjects achieving antibody responses to specific antigens with results greater than or equal to thresholds specific to each of the 4 antigens in the vaccine at at each applicable visit | various, up to 12 months |
| South Miami |
| Florida |
| 33143 |
| United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | 40004 | United States |
| SNBL Clinical Pharmacology Center, Inc. | Baltimore | Maryland | 21201 | United States |
| Prism Research | Saint Paul | Minnesota | 55114 | United States |
| Buffalo Clinical Research Center, LLC | Buffalo | New York | 14202 | United States |
| PMG Research of Raleigh, LLC d/b/a PMG Research of Cary | Cary | North Carolina | 27518 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45206 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| New Orleans Center for Clinical Research | Knoxville | Tennessee | 37920 | United States |
| Volunteer Research Group | Knoxville | Tennessee | 37920 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Benchmark Research | Austin | Texas | 78705 | United States |
| Roberta Braun, M.D. | Austin | Texas | 78705 | United States |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | United States |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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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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