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SA4Ag vaccine low dose

Phase 1

Staphylococcal Infections | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Mar 4, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment840

FDA Designations

No designations recorded

Clinical trial landscape

SA4Ag vaccine low dose · 3 trials · 1 indication

Phase 1 3
NCT02364596Evaluation of a Single Vaccination With a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 YearsStaphylococcal Infections
COMPLETED100 Analytics
NCT01643941Evaluation of a Single Vaccination of One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) and a Single Dose Level of a 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) in Healthy Adults Aged 65 to <86 YearsStaphylococcal Infections
COMPLETED284 Analytics
NCT01364571Evaluation 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 YearsStaphylococcal Infections
COMPLETED456 Analytics
PHASE1COMPLETED
Evaluation of a Single Vaccination With a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years
Staphylococcal Infections
NCT02364596100
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PHASE1COMPLETED
Evaluation of a Single Vaccination of One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) and a Single Dose Level of a 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) in Healthy Adults Aged 65 to <86 Years
Staphylococcal Infections
NCT01643941284
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PHASE1COMPLETED
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
Staphylococcal Infections
NCT01364571456
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Study Endpoints

Primary Endpoints

Number of subjects reporting local reactions (redness, swelling, and pain at the injection site) as self-reported on electronic diaries (e-diaries) for 10 days after vaccination.
10 days
Number of subjects reporting systemic events (fever, fatigue, headache, vomiting, diarrhea, muscle pain, and joint pain) as self-reported on e-diaries for 10 days after vaccination.
10 days
Number of subjects reporting adverse events (AEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA).
1 month
Number of subjects reporting serious adverse events (SAEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA).
1 month
Opsonophagocytic activity titers measured as geometric mean titers against S. aureus isolates
1 month
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
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 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

Secondary Endpoints

Competitive Luminex immunoassay titers summarized as geometric mean titers for S. aureus antigens
1 month
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.
various, up to 12 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALSA4Ag vaccine
2EXPERIMENTALSA4Ag vaccine mid dose
3EXPERIMENTALSA4Ag vaccine high dose
4EXPERIMENTALSA3Ag vaccine
5PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
SA4Ag vaccineBIOLOGICALSubjects receive 1 intramuscular injection (0.5 mL) of the SA4Ag vaccine.
Blood samplePROCEDUREBlood for immunogenicity will be collected from all subjects at various timepoints.
SA4Ag vaccine low doseBIOLOGICALSubjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine.
Blood drawPROCEDUREBlood 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 samplePROCEDUREColonization swabs will be collected from all subjects at various timepoints.
SA4Ag vaccine mid doseBIOLOGICALSubjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine.
SA4Ag vaccine high doseBIOLOGICALSubjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine.
SA3Ag vaccineBIOLOGICALPhase 2 only: Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA3Ag vaccine.
PlaceboBIOLOGICALSubjects receive one intramuscular injection (0.5 mL) of placebo which contains excipients of the vaccine formulation minus the active ingredients.
Colonization swab samplesPROCEDUREColonization swabs will be collected from all subjects at various timepoints.
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: 1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other stud...

Countries:United States
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Frequently asked questions about SA4Ag vaccine low dose

What is SA4Ag vaccine low dose used for?

SA4Ag vaccine low dose is an investigational vaccine being studied for the prevention of Staphylococcal Infections. It is a 4-antigen Staphylococcus aureus vaccine designed to elicit an immune response against the bacteria. The vaccine is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes SA4Ag vaccine low dose?

SA4Ag vaccine low dose is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational vaccine in healthy adult populations.

What phase is SA4Ag vaccine low dose in?

SA4Ag vaccine low dose is in Phase 1 clinical development. All three completed trials for this vaccine were Phase 1 studies. The vaccine is investigational and has not received regulatory approval for any indication.

What clinical trials is SA4Ag vaccine low dose in?

SA4Ag vaccine low dose has been evaluated in three completed Phase 1 trials: NCT01364571 (456 participants, ages 18-64), NCT01643941 (284 participants, ages 65-85), and NCT02364596 (100 participants, ages 18-64). All trials were conducted in the United States and enrolled healthy adults.

Is SA4Ag vaccine low dose the same as SA3Ag?

No, SA4Ag vaccine low dose is a 4-antigen Staphylococcus aureus vaccine, while SA3Ag is a separate 3-antigen version. Both were evaluated in the same Phase 1 trial NCT01643941, which tested three dose levels of SA4Ag and one dose level of SA3Ag in older adults.