Physicians | Strive Physicians Information
A medical research study to evaluate an investigational vaccine against Staphylococcus aureus (staph) infections, is now accepting study participants.
clinical trial, clinical study, investigational vaccine, Staphylococcus aureus, investigational vaccine for Staphylococcus aureus, accepting study participants, medical research study
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S. aureus Vaccine Key Program Findings

S. aureus disease affects many patient populations and results in diverse clinical presentations
Pyramid updated 06Sep2016

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MRSA=methicillin-resistant Staphylococcus aureus; MSSA=methicillin-sensitive Staphylococcus aureus1. Foster T. Staphylococcus. In: Baron S, ed. Medical Microbiology. Galveston, TX: University of Texas Medical Branch at Galveston; 1996. 2. Liu C et al. Clin Infect Dis 2011;52:285-292. 3. Styers D et al. Ann Clin Micro Antimicrob 2006;5:2. 4. Kuehnert MJ et al.  J Infect Dis 2006;193:172-179. 5. von Eiff C et al. N Engl J Med. 2001;344:11-16. 6. Hersh AL et al. Arch Intern Med. 2008;168:1585–1591. 7. Centers for Disease Control and Prevention. MRSA and the workplace [updated 19 September 2014]. Available from: http://www.cdc.gov/niosh/topics/mrsa/. 8. Laupland KB et al. J Infect Dis. 2003;187:1452-1459.  9. National Nosocomial Infections Surveillance System. Am J Infect Control 1996;24(5):380-388. 10. Eili Klein*, David L. Smith†, and Ramanan Laxminarayan. Hospitalizations and Deaths Caused by Methicillin-Resistant Staphylococcus aureus, United States, 1999–2005. Volume 13, Number 12—December 2007 Research. 11. Koeck et al, Invasive Staphylococcus aureus Infections in Minnesota: A Large Role for MSSA. IDWeek 2015  12. CDC. 2014. Active Bacterial Core Surveillance Report, Emerging Infections Program Network, Methicillin-Resistant Staphylococcus aureus, 2014. Available via the Internet: http://www.cdc.gov/abcs/reports-findings/survreports/mrsa14.html 13. CDC data (Scott Fridkin/CDC) (June 7, 2016)
S. aureus Vaccine (SA4Ag) is Designed To Target Multiple Virulence Mechanisms
Virulence Mechanism
Target Antigens
Functional Immunoassay(s)
Anti-phagocytic Capsular polysaccharides (CP5 and CP8): CP5-CRM197, CP8-CRM197 OPA
cLIA
Adhesion to host factors Clumping factor A (ClfA): rmClfA FBI
cLIA
Divalent cation scavenging (nutrient acquistion) Manganese transporter C (MntC): rP305A cLIA
  • Selected antigens elicit immune responses targeting surface-expressed, conserved, and globally represented S. aureus components expressed during infection
  • Being investigated to determine if it’s broadly protective across the range of clinical S. aureus disease isolates regardless of their antibiotic resistance profiles or geographic origin
Nanra JS, et al. Hu Vacc Immunotherapeutics 2013; 9(3):480-7;
Rozemeijer W, et al. ICAAC 2012 (G-870);
Hawkins J, et al. Clin Vacc Immunology 2012; 19(10):1641-50
SA4Ag Clinical Development Program to Date
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1. Nissen M, et al. Vaccine. 2015;33(15):1846-54 (Clinicaltrials.gov: NCT01018641). 2.  Frenck RW Jr., et al. Open Forum Infect Dis (Fall 2014) 1 (suppl 1):S25. Oral presentation at IDWeek; Oct 8–12, 2014; Philadelphia, PA, USA (Clinicaltrials.gov: NCT01364571).   3. Scully et al. Surg Infect (Larchmt). 2015;16 (Suppl 1):S-30. Poster presentation at the Surgical Infection Society-35th Annual Meeting; Apr 15–18, 2015; Westlake Village, CA, USA (Clinicaltrials.gov: NCT01364571).   4.  Creech CB, et al. Open Forum Infect Dis (Fall 2015) 2 (suppl 1):S36. Oral presentation at IDWeek; Oct 7–11, 2015; San Diego, CA, USA (Clinicaltrials.gov: NCT01643941).   5.  Begier E, et al. Poster presentation at the Surgical Infection Society-36th Annual Meeting; May 18–21, 2016; Palm Beach, FL, USA (Clinicaltrials.gov: NCT02364596).   6.  Study ongoing (Clinicaltrials.gov: NCT02492958).   7.  Study ongoing (Clinicaltrials.gov: NCT02388165).
SA4Ag Elicits a Rapid and Sustained Immune Response through Month 12
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*SA4Ag includes 30 µg of CP5-CRM197, 30 µg of CP8-CRM197, 60 µg of rmClfA, and 200 µg of rP305A (MntC)

Injection Site Reactions (adults 18 to <65 yrs)
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  • Reactions at injection site were generally mild to moderate in severity and lasted 1-3 days
  • Onset usually within first 3 days
  • Severe reactions required no specific treatment, lasted a few days
Injection Site Reactions (adults 65 to <86 years)
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  • Reactions at injection site were mostly mild and generally lasted 1-4 days
  • Onset usually within first 3 days
    • Several subjects reported onset of local reactions around Day 7, almost all resolved by Day 10.
Systemic Events (adults 18 to <65 years)
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  • Systemic events reported in e-diary through 14 days after vaccination;
  • B3451001 study in healthy adults aged 18 to <65 years, placebo and high dose SA4Ag groups
  • General symptoms were similar in those who received SA4Ag and placebo
Systemic Events (adults 65 to <86 years)
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  • Systemic events reported in e-diary through 14 days after vaccination;
  • B3451011 study in healthy adults aged 65 to <86 years, placebo and high dose SA4Ag groups
  • General symptoms were similar in those who received SA4Ag and placebo
Phase 1/2a: Summary and Conclusions
  • > 1,000 healthy subjects have received Pfizer’s investigational S. aureus vaccine in Phase 1/2 clinical trials to date
  • SA4Ag was generally well tolerated, with no safety concerns in healthy adults 18 to <86 years
  • A single dose of SA4Ag induces a rapid rise in bacteria-killing antibodies that is sustained through at least 12 months after vaccination in healthy adults 18 to <86 years
  • The STRIVE study (B3451002) is being conducted in patients undergoing elective open posterior instrumented spinal fusion procedures to further evaluate the safety and efficacy of SA4Ag