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SA4Ag vaccine low dose

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment840
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02364596Evaluation of a Single Vaccination With a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 YearsPHASE1 COMPLETED 100 — — Jan 1, 2015Feb 1, 2015Apr 3, 20152 United States
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 YearsPHASE1 COMPLETED 284 — — Aug 1, 2012Mar 1, 2014Mar 4, 20197 United States
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 YearsPHASE1 COMPLETED 456 — — Aug 1, 2011Jan 1, 2013Mar 4, 201916 United States
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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 — 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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