Table 1.

Clinical trials involving active vaccination with SAg toxoids or passive vaccination with therapeutic antisera.

Vaccination Type	Target	Name (Company; NCT Number 1)	Study Design	Status and Study Results	Intervention	Duration	Ref.
Active	SEB 2	STEBVax (Integrated BioTherapeu- tics; NCT00974935)	Non-randomized, dose escalation	Phase I, completed. STEBvax was safe, well-tolerated and immunogenic, induced/boosted toxin-neutralizing antibodies	STEBVax vaccine 3 with Alhydrogel adjuvant, six doses (10 ng–20 µg) or 20 µg given in two vaccinations 21 days apart	02/11- 03/15	[48]
Active	TSST-1 4	rTSST-1v 5 (Biomedizi- nische Forschungs GmbH; NCT02340338)	Randomized, double-blind, adjuvant- controlled dose escalation	Phase I, completed. rTSST-1v was safe, well-tolerated, and immunogenic, induced/boosted toxin-neutralizing antibodies	rTSST-1 variant 5 with Al(OH)3, six doses in one to two vaccinations (100 ng–30 µg)	06/14- 06/15	[49]
Active	TSST-1	rTSST-1v (Biomedizi- nische Forschungs GmbH; NCT02814708)	Randomized, placebo- controlled	Phase II, ongoing	rTSST-1 variant 3 with Al(OH)3, two doses (10, 100 µg) in one to three vaccinations	Since 03/16	-
Passive	SAgs	IVIG 6 (Hospices Civils de Lyon; NCT02219165)	Randomized, placebo- controlled	Phase II, completed	IVIG (single dose, 2 g/kg)	Since 01/15	-

¹ ClinicalTrials.gov Identifier (https://clinicaltrials.gov/), ² SEB, staphylococcal enterotoxin B, ³ STEBVax is a recombinant detoxified version of the SAg SEB lacking toxic and superantigenic properties. The mutant contains mutations in the hydrophobic binding loop (L45R), the polar binding pocket (Y89A), and the disulfide loop (Y94A), thereby disrupting the interaction of the toxin with human MHC-II molecules. ⁴ TSST-1, toxic shock syndrome toxin 1, ⁵ TSST-1variant (TSST-1v) is a recombinant detoxified version of the SAg TSST-1 lacking toxic and superantigenic properties. The double mutation G31R-H135A impairs rTSST-1v binding to both MHC-II molecules and to the TCR. ⁶ IVIG, intravenous immunoglobulins.