PMID- 37125490
OWN - NLM
STAT- MEDLINE
DCOM- 20230728
LR  - 20230729
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Print)
IS  - 1058-4838 (Linking)
VI  - 77
IP  - 2
DP  - 2023 Jul 26
TI  - Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The 
      STaphylococcus aureus suRgical Inpatient Vaccine Efficacy (STRIVE) Randomized 
      Clinical Trial.
PG  - 312-320
LID - 10.1093/cid/ciad218 [doi]
AB  - BACKGROUND: Staphylococcus aureus is a global pathogen that is frequently 
      responsible for healthcare-associated infections, including surgical site 
      infections (SSIs). Current infection prevention and control approaches may be 
      limited, with S. aureus antibiotic resistance remaining problematic. Thus, a 
      vaccine to prevent or reduce S. aureus infection is critically needed. We 
      evaluated the efficacy and safety of an investigational 4-antigen S. aureus 
      vaccine (SA4Ag) in adults undergoing elective open posterior spinal fusion 
      procedures with multilevel instrumentation. METHODS: In this multicenter, 
      site-level, randomized, double-blind trial, patients aged 18-85 years received a 
      single dose of SA4Ag or placebo 10-60 days before surgery. SA4Ag efficacy in 
      preventing postoperative S. aureus bloodstream infection and/or deep incisional 
      or organ/space SSIs was the primary end point. Safety evaluations included local 
      reactions, systemic events, and adverse events (AEs). Immunogenicity and 
      colonization were assessed. RESULTS: Study enrollment was halted when a 
      prespecified interim efficacy analysis met predefined futility criteria. SA4Ag 
      showed no efficacy (0.0%) in preventing postoperative S. aureus infection (14 
      cases in each group through postoperative day 90), despite inducing robust 
      functional immune responses to each antigen compared with placebo. Colonization 
      rates across groups were similar through postoperative day 180. Local reactions 
      and systemic events were mostly mild or moderate in severity, with AEs reported 
      at similar frequencies across groups. CONCLUSIONS: In patients undergoing 
      elective spinal fusion surgical procedures, SA4Ag was safe and well tolerated 
      but, despite eliciting substantial antibody responses that blocked key S. aureus 
      virulence mechanisms, was not efficacious in preventing S. aureus infection. 
      Clinical Trials Registration. NCT02388165.
CI  - (c) The Author(s) 2023. Published by Oxford University Press on behalf of 
      Infectious Diseases Society of America.
FAU - Hassanzadeh, Hamid
AU  - Hassanzadeh H
AD  - Department of Orthopaedic Surgery, Johns Hopkins University, Baltimore, Maryland, 
      USA.
FAU - Baber, James
AU  - Baber J
AD  - Pfizer Inc, Vaccine Clinical Research, Sydney, New South Wales, Australia.
FAU - Begier, Elizabeth
AU  - Begier E
AUID- ORCID: 0000-0002-1287-5416
AD  - Pfizer Inc, Vaccine Research, Pearl River, New York, USA.
FAU - Noriega, David C
AU  - Noriega DC
AD  - Department of Orthopaedics, Hospital Universitario de Valladolid, Valladolid, 
      Spain.
FAU - Konishi, Hiroaki
AU  - Konishi H
AD  - Department of Orthopaedic Surgery, Nagasaki Rosai Hospital, Nagasaki, Japan.
FAU - Yato, Yoshiyuki
AU  - Yato Y
AD  - National Hospital Organization Murayama Medical Center, Orthopedics and Sports 
      Medicine Neurosciences & Neurology Surgery, Tokyo, Japan.
FAU - Wang, Michael Y
AU  - Wang MY
AD  - Neurological Surgery, University of Miami, Miami, Florida, USA.
FAU - Le Huec, Jean Charles
AU  - Le Huec JC
AD  - Department of Orthopaedic and Traumatology, Polyclinique Bordeaux Nord Aquitaine, 
      Bordeaux University, Bordeaux, France.
FAU - Patel, Vikas
AU  - Patel V
AD  - Department of Orthopaedic Surgery, University of Colorado School of Medicine, 
      Denver, Colorado, USA.
FAU - Varga, Peter
AU  - Varga P
AD  - National Center for Spinal Disorders, Buda Health Center, Spine Center, Budapest, 
      Hungary.
FAU - Liljenqvist, Ulf
AU  - Liljenqvist U
AD  - Department of Orthopaedic Surgery, St. Franziskus-Hospital Munster Orthopaedie 
      II, Muenster, Germany.
FAU - Conly, John
AU  - Conly J
AD  - Department of Medicine, Foothills Medical Centre, Alberta Health Services and 
      University of Calgary, Calgary, Alberta, Canada.
FAU - Sabharwal, Charu
AU  - Sabharwal C
AD  - Pfizer Inc, Vaccine Research, Pearl River, New York, USA.
FAU - Munjal, Iona
AU  - Munjal I
AD  - Pfizer Inc, Vaccine Research, Pearl River, New York, USA.
FAU - Cooper, David
AU  - Cooper D
AD  - Pfizer Inc, Vaccine Research, Pearl River, New York, USA.
FAU - Radley, David
AU  - Radley D
AD  - Pfizer Inc, Vaccine Research, Pearl River, New York, USA.
FAU - Jaques, Anna
AU  - Jaques A
AD  - Pfizer Inc, Vaccine Clinical Research, Sydney, New South Wales, Australia.
FAU - Patton, Michael
AU  - Patton M
AD  - Pfizer Ltd, Vaccine Clinical Research, Hurley, United Kingdom.
FAU - Gruber, William C
AU  - Gruber WC
AD  - Pfizer Inc, Vaccine Research, Pearl River, New York, USA.
FAU - Jansen, Kathrin U
AU  - Jansen KU
AD  - Pfizer Inc, Vaccine Research, Pearl River, New York, USA.
FAU - Anderson, Annaliesa S
AU  - Anderson AS
AD  - Pfizer Inc, Vaccine Research, Pearl River, New York, USA.
FAU - Gurtman, Alejandra
AU  - Gurtman A
AD  - Pfizer Inc, Vaccine Research, Pearl River, New York, USA.
CN  - STaphylococcus aureus suRgical Inpatient Vaccine Efficacy Investigator Team
LA  - eng
SI  - ClinicalTrials.gov/NCT02388165
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases 
      Society of America
JID - 9203213
RN  - 0 (Vaccines, Conjugate)
SB  - IM
CIN - Clin Infect Dis. 2023 Jul 26;77(2):321-322. PMID: 37119277
MH  - Adult
MH  - Humans
MH  - *Staphylococcus aureus
MH  - Inpatients
MH  - Vaccine Efficacy
MH  - *Staphylococcal Infections/prevention & control
MH  - Surgical Wound Infection/prevention & control
MH  - Vaccines, Conjugate
MH  - Double-Blind Method
PMC - PMC10371312
OTO - NOTNLM
OT  - Staphylococcus aureus
OT  - efficacy
OT  - spinal surgery
OT  - surgical site infection
OT  - vaccine
COIS- Potential conflicts of interest. H. H. is a consultant for Medtronic, DePuy, 
      Nuvasive, and Orthofix; has obtained research support from Orthofix, Nuvasive, 
      Medtronic, SKK, and Pfizer; has taught/spoken for Nuvasive, Medtronic, Orthofix, 
      and Globus; has received payment for expert testimony from the Expert Institute; 
      has participated on an advisory board for MTF; and reports stock or stock options 
      with Nuvasive and 4Web. V. P. is a consultant for Medtronic; has obtained 
      research support from Pfizer, Orthofix, Medicrea, Mainstay Medical, SI Bone, and 
      Premia Spine; reports grants or contracts from Spinal Kinetics; reports 
      consulting fees from DePuy Synthes, J&J SI-BONE, Mainstay Medical, Zimmer, 
      Baxter, Stryker, and Aesculap; has filed multiple patents with the university 
      office; and receives royalties from Stryker and Aesculap. H. K. has served as a 
      consultant for Pfizer. D. N. is a consultant for Stryker. J. B., E. B., C. S., I. 
      M., D. C., D. R., A. J., M. P., W. C. G., K. U. J., A. S. A., and A. G. are 
      current employees of Pfizer and may hold stock or stock options. A. J. reports 
      support for attending meetings as part of duties as a Pfizer employee and STRIVE 
      team member. J. C. reports grants or contracts from the Canadian Institutes for 
      Health Research and from Alberta Innovates; has received accommodations and 
      airfare to attend and speak at a symposium from bioMerieux Canada; and is a 
      member and chair of the World Health Organization (WHO) and a member of the WHO 
      Health Emergencies Programme Ad-hoc COVID-19 IPC Guidance Development Group, both 
      of which provide multidisciplinary advice to the WHO, for which no funding is 
      received and from which no funding recommendations are made for any WHO contracts 
      or grants; and works as an infectious diseases consultant at Alberta Health 
      Services. K. J. reports consulting fees from and patents with Pfizer. M. W. 
      reports royalties or licenses from Depuy-Synthes Spine; consulting fees from 
      Depuy-Synthes Spine, Pacira, Stryker, NuVasive, Spineology, and Surgalign; and 
      stock or stock options from Innovasive Surgical Devices, Kinesiomerics, and 
      Medical Device Partners. All other authors report no potential conflicts. All 
      authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of 
      Interest. Conflicts that the editors consider relevant to the content of the 
      manuscript have been disclosed.
FIR - Zenilman, Jonathan
IR  - Zenilman J
FIR - Salata, Robert
IR  - Salata R
FIR - Schaffner, William
IR  - Schaffner W
FIR - Blackwelder, William
IR  - Blackwelder W
FIR - Leaper, David
IR  - Leaper D
EDAT- 2023/05/01 06:42
MHDA- 2023/07/28 06:43
PMCR- 2023/05/01
CRDT- 2023/05/01 04:23
PHST- 2022/11/02 00:00 [received]
PHST- 2023/07/28 06:43 [medline]
PHST- 2023/05/01 06:42 [pubmed]
PHST- 2023/05/01 04:23 [entrez]
PHST- 2023/05/01 00:00 [pmc-release]
AID - 7147455 [pii]
AID - ciad218 [pii]
AID - 10.1093/cid/ciad218 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2023 Jul 26;77(2):312-320. doi: 10.1093/cid/ciad218.