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This is a Phase 1 and Phase 2 study of a single vaccination with one of three dose levels of a 4-antigen investigational vaccine against Staphylococcus aureus (SA4Ag) and a single dose level of a 3-antigen Staphylococcus aureus vaccine (SA3Ag). 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 65 to <86 years. In addition, the study aims to assess the effect of the Staphylococcus aureus vaccine on the presence of the Staphylococcus aureus within the nose, throat and perineal skin of healthy adults aged 65 to <86 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | SA4Ag vaccine low dose |
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| 2 | Experimental | SA4Ag vaccine mid dose |
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| 3 | Experimental | SA4Ag vaccine high dose |
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| 4 | Experimental | SA3Ag vaccine |
|
| 5 | 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 solicited 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 | 14 days | |
| 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 vaccine components with results ≥ thresholds defined for each vaccine component based on immunoglobulin-binding and/or opsonphagocytic activity assays | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Immunoglobulin titers measured as geometric mean titers for each antigen at each applicable blood sampling time point, as measured by antigen-specific antibody levels using an immunoglobulin binding assay. | various, up to 12 months | |
| Opsonophagocytic activity titers measured as geometric mean titers against S. aureus isolates at each applicable blood sampling time point. |
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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. | |
| 27866765 |
| 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 HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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 timepoints. |
|
| SA4Ag vaccine mid dose | Biological | Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine. |
|
| Blood draw | Procedure | Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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 timepoints. |
|
| 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 HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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 timepoints. |
|
| SA3Ag vaccine | Biological | Phase 2 only: Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA3Ag vaccine. |
|
| Blood sample | Procedure | 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 timepoints. |
|
| Placebo | Biological | Subjects receive one intramuscular injection (0.5 mL) of placebo which contains excipients of the vaccine formulation minus the active ingredients. |
|
| Blood draw | Procedure | Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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 samples | Procedure | Colonization swabs will be collected from all subjects at various timepoints. |
|
| various, up to 12 months |
| Immunoglobulin geometric mean fold rise for each of the vaccine components as measured by antigen-specific antibody levels using an immunoglobulin binding assay. | 1 month |
| Geometric mean fold rise on opsonophagocytic activity assay titers against S. aureus isolates. | 1 month |
| Proportion of subjects achieving antibody responses to specific antigens with results ≥ thresholds defined for each vaccine component at each applicable visit. | Various, up to 12 months |
| Proportion of subjects with ≥2-fold, ≥4-fold, ≥8-fold, ≥16-fold, and ≥32-fold increase in immunoglobulin titers from baseline to each applicable visit after vaccination for each antigen. | Various, up to 12 months |
| Proportion of subjects with ≥2-fold, ≥4-fold, ≥8-fold, ≥16-fold, and ≥32-fold increase in opsonophagocytic activity titers against S. aureus isolates from baseline to each applicable visit after vaccination. | Various, up to 12 months |
| South Miami |
| Florida |
| 33143 |
| United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
| PMG Research of Raleigh, LLC | Cary | North Carolina | 27518 | United States |
| Cincinnati Children's Hospital Medical Center Gamble Program for Clinical Studies | Cincinnati | Ohio | 45206 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Benchmark Research | Austin | Texas | 78705 | United States |
| Derived |
| Creech CB, Frenck RW Jr, Sheldon EA, Seiden DJ, Kankam MK, Zito ET, Girgenti D, Severs JM, Immermann FW, McNeil LK, Cooper D, Jansen KU, Gruber W, Eiden J, Anderson AS, Baber J. Safety, tolerability, and immunogenicity of a single dose 4-antigen or 3-antigen Staphylococcus aureus vaccine in healthy older adults: Results of a randomised trial. Vaccine. 2017 Jan 5;35(2):385-394. doi: 10.1016/j.vaccine.2016.11.032. Epub 2016 Nov 17. |
| 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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