TY - JOUR
T1 - S. aureus colonization in healthy Australian adults receiving an investigational S. aureus 3-antigen vaccine
AU - Marshall, Helen S.
AU - Baber, James
AU - Richmond, Peter
AU - Nissen, Michael
AU - Shakib, Sepehr
AU - Kreiswirth, Barry N.
AU - Zito, Edward T.
AU - Severs, Joseph
AU - Eiden, Joseph
AU - Gruber, William
AU - Jansen, Kathrin U.
AU - Jones, C. Hal
AU - Anderson, Annaliesa S.
N1 - Funding Information:
Helen Marshall has been a principal investigator on vaccine clinical trials sponsored by GSK, Pfizer, and Novartis, with her institution receiving funding to conduct these trials. She has received travel support to present scientific data at international meetings from GSK. Her institution has received grant funding for investigator‑led studies from Pfizer, GSK, and Seqirus, none being relevant to this study. Michael Nissen receives personal fees from GSK Vaccines as a full-time employee since October 2014 and he has been principal investigator of clinical trials sponsored by Baxter, bioCSL, GSK, Merck, Sanofi, and Pfizer and has received travel support to present these data at scientific conferences. Michael Nissen has also received an independent study grant from Abbott Australia which is not relevant to the submitted work. Peter Richmond has been principal investigator of clinical trials sponsored by GSK, Merck, Sanofi, and Pfizer and has received travel support to present these data at scientific conferences. Peter Richmond has also received institutional funding from GSK for investigator-led studies and participated in scientific advisory boards for Pfizer and GSK. Sepehr Shakib was principal investigator as a contractor on this study at the CMAX clinical trial unit. He has no conflict of interest to declare. Barry Kreiswirth receives consultancy fees from Pfizer and Shionogi. James Baber, William Gruber, Kathrin U. Jansen, Annaliesa S. Anderson, and C. Hal Jones are employees of Pfizer. Joseph Severs, Edward T. Zito, and Joseph Eiden are former employees of Pfizer.
Publisher Copyright:
© 2019
PY - 2019
Y1 - 2019
N2 - Objectives: Assess Staphylococcus aureus (S. aureus) colonization in healthy Australian adults receiving an investigational S. aureus 3-antigen vaccine (SA3Ag). Methods: In this phase 1, double-blind, sponsor-unblinded study, participants were randomized to receive a single dose (1 of 3 dose levels) of SA3Ag or placebo and a booster dose or placebo at 6 months. S. aureus isolates from nasal, perineal, and oropharyngeal swabs before and through 12 months post-vaccination were identified. Results: Baseline S. aureus colonization prevalence was 30.6% (any site), with nasal carriage (27.0%) more common than oropharyngeal/perineal (3.2% each). Following initial vaccination (low-dose: 102; mid-dose: 101; high-dose: 101; placebo: 102) and booster (low-dose: 45; mid-dose: 44; high-dose: 27; placebo: 181), placebo and SA3Ag groups showed similar S. aureus carriage through 12 months. Most colonized participants (74.0%) were colonized by single spa types. Placebo and SA3Ag groups had similar persistence of colonization, with 19.6–30.7% due to single spa types. Acquisition was observed in mid- and high-dose recipients (∼20%) and low-dose and placebo recipients (∼12%). Vaccination resulted in substantial increases in antibodies to all 3 antigens, irrespective of carriage status. Conclusions: Based on descriptive analyses of this small study, SA3Ag vaccination did not impact S. aureus acquisition or carriage. Carriage status did not impact antibody responses to SA3Ag.
AB - Objectives: Assess Staphylococcus aureus (S. aureus) colonization in healthy Australian adults receiving an investigational S. aureus 3-antigen vaccine (SA3Ag). Methods: In this phase 1, double-blind, sponsor-unblinded study, participants were randomized to receive a single dose (1 of 3 dose levels) of SA3Ag or placebo and a booster dose or placebo at 6 months. S. aureus isolates from nasal, perineal, and oropharyngeal swabs before and through 12 months post-vaccination were identified. Results: Baseline S. aureus colonization prevalence was 30.6% (any site), with nasal carriage (27.0%) more common than oropharyngeal/perineal (3.2% each). Following initial vaccination (low-dose: 102; mid-dose: 101; high-dose: 101; placebo: 102) and booster (low-dose: 45; mid-dose: 44; high-dose: 27; placebo: 181), placebo and SA3Ag groups showed similar S. aureus carriage through 12 months. Most colonized participants (74.0%) were colonized by single spa types. Placebo and SA3Ag groups had similar persistence of colonization, with 19.6–30.7% due to single spa types. Acquisition was observed in mid- and high-dose recipients (∼20%) and low-dose and placebo recipients (∼12%). Vaccination resulted in substantial increases in antibodies to all 3 antigens, irrespective of carriage status. Conclusions: Based on descriptive analyses of this small study, SA3Ag vaccination did not impact S. aureus acquisition or carriage. Carriage status did not impact antibody responses to SA3Ag.
KW - Colonization
KW - Methicillin-resistant Staphylococcus aureus
KW - Spa typing
KW - Staphylococcus aureus acquisition
KW - Staphylococcus aureus vaccine
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U2 - 10.1016/j.jinf.2019.09.018
DO - 10.1016/j.jinf.2019.09.018
M3 - Article
C2 - 31585191
AN - SCOPUS:85074455763
SN - 0163-4453
JO - Journal of Infection
JF - Journal of Infection
ER -