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. Author manuscript; available in PMC: 2020 Apr 1.
Published in final edited form as: Trends Microbiol. 2019 Jan 19;27(4):303–322. doi: 10.1016/j.tim.2018.12.009

Table 2:

Clinical trials involving therapeutic antibodies/antisera against S. aureus infections*

Targeta Name
[Company; NCT numberb]
Study Design Status (study result) Interventionc Ref
Single component
ClfA (adhesin) Tefibazumab (Aurexis®)
[Inhibitex]
randomized, double-blind, placebo-controlled trial of bacteremia patients receiving standard antibiotic treatment plus Tefibazumab (N = 63) Phase II (failed) Huz/mAb (IgG1) [104]
Tefibazumab (Aurexis®)
[Inhibitex; NCT00198289]
dose escalation study of Aurexis® in cystic fibrosis patients chronically colonized with S. aureus in their lung (N = 30) Phase IIa (failed) Huz/mAb (IgG1) i
CP 5 and CP8 (capsular polysaccharides) AltaStaph™  
[Nabi Biopharmaceuticals;  NCT00063089]
randomized, double-blind, placebo-controlled trial involving adult S. aureus bacteremia patients receiving standard treatment plus Altastaph (N = 40) Phase II (halted) polyclonal human IgG with high antibody titers against CP5 and CP8, purified from the plasma of healthy donors that have been vaccinated with StaphVAXd [105]
AltaStaph™  
[Nabi Biopharmaceuticals;  NCT00066989]
randomized, double-blind, placebo-controlled trial for prevention of nosocomial S. aureus infections in very low birth weight (VLBW) neonates (N = 206) Phase II (failed) same as above [106]
LTA (cell wall component) Pagibaximab®
[Biosynexus; NCT00631800]
randomized, double-blind, placebo-controlled dose-ranging study on prevention of CoNS and S. aureus sepsis in VLBW neonates (N = 88) Phase II (finished) murine/human chimeric mAb [127]
Pagibaximab®
[Biosynexus; NCT00646399]
randomized, double-blind, placebo-controlled study on prevention of staphylococcal sepsis in VLBW neonates (N = 1579) Phase III (failed) murine/human chimeric mAb [108]
WTA (wall teichoic acid) DSTA4637S
[Roche/Genentech; NCT03162250]
randomized double-blind, placebo-controlled multiple-ascending dose study on safety, tolerability, and pharmacokinetics in S. aureus bacteremia (N = 24) Phase lb (ongoing) THIOMAB™ antibody (Hu/mAb; IgG1)-antibiotic conjugate [114,115]
PNAG (cell wall component) SAR279356
[Sanofi-Aventis; NCT01389700]
randomized, double-blind, placebo-controlled study to assess a single dose of SAR279356 in ICU patients on mechanical ventilation (N = 7) Phase IIa (terminated due to difficulty in patient recruitment) Hu/mAb ii
Hla (toxin) MEDI4893 (Suvratoxumab)
[MedImmune LLC; NCT02296320]
randomised, double-blind, placebo-controlled, single-dose, dose-ranging study in mechanically ventilated adult subjects (N = 213) Phase II (ongoing) Hu/mAb (IgG1) [111]
AR-301 (Salvecin®)  
[Aridis Pharmaceuticals;  NCT01589185]
randomized, double-blind, placebo-controlled, single dose study of AR-301 as an adjunctive therapy against severe S. aureus-related pneumonia (N = 48) Phase IIa (successful) Hu/mAb (IgG1) iii
GrfA (ABC transporter) Aurograb®  
[NeuTec Pharma Ltd./Novartis  Pharma AG; NCT00217841]
randomised, double-blind, placebo-controlled trial of patients with severe, deep-seated staphylococcal infections receiving vancomycin plus Aurograb (N = 180) Phase II (failed), development stopped single chain antibody fragment (Fab) [134,144]
Multi-component
ClfA (S. aureus), SdrG (S.  epidermidis)  (adhesins) INH-A21 (Veronate®)
[Inhibitex / Bristol Myers-Squibb; NCT00113191]
randomized, double-blind, placebo-controlled study of INH-A21 for prevention of staphylococcal late-onset sepsis in VLBW infants (N = 1983) Phase III (failed) Pooled human Ig purified from the serum of donors with high titers against ClfA and SdrG [113]
Hla, HlgAB, HlgCB, LukED, LukSF,  LukAB (toxins) ASN100  
[Arsanis Biosciences GmbH;  NCT02940626]
randomized, double-blind, single-dose, placebo-controlled study of ASN100 for the prevention of S. aureus pneumonia in heavily-colonized, mechanically ventilated subjects (N = 354) Phase II (halted) Hu/mAb combination of ASN-1 (IgG1, crossreactive mAb with affinity for Hla, HlgAB, HlgCB, LukED and LukSF) and ASN-2 (IgG1, mAb against LukAB) [95,112]
*

data based on publications, review of sponsor website information as well as clinical trial data accessible via www.clinicaltrials.gov on 20.08.2018.

a

Abbreviations: ClfA, clumping factor A; LTA, lipoteichoic acid; PNAG, ß-1,6-poly-N-acetylglucosamine; Hla, α-toxin; SdrG, Serine- aspartate repeat- containing protein G; HlgAB and HlgCB, γ-haemolysin AB and CB; LukED and LukSF, leukotoxin ED and SF; NA, data not available; VLBW, very low birth weight.

b

ClinicalTrials.gov Identifieriv

c

Antibodies applied in clinical studies were either murine, chimeric, humanized or human (see Glossary)

d

StaphVAX® is a bivalent S. aureus vaccine which contains the purified capsular polysaccharides (CPS) types 5 and 8v. Its development was halted by Nabi due to failure in preventing S. aureus infections in kidney disease patients in a confirmatory phase III clinical trialvi.. The company also halted the development of Altastaph™, as it is based on the same capsular polysaccharide technology as StaphVAX®.

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