Drug intelligence / Profile preview

Simplirix (GSK)

Development stage
Discontinued
Lead developer
GSK
Modality
Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
Administration
Intramuscular
01

Overview

Simplirix (gD-Alum/MPL) is an investigational recombinant subunit vaccine developed by GSK for the prevention of genital herpes. The vaccine consists of a truncated version of the Herpes Simplex Virus type 2 (HSV-2) glycoprotein D (gD2) combined with the AS04 adjuvant system, which comprises aluminum hydroxide and the Toll-like receptor 4 (TLR4) agonist 3-O-desacyl-4'-monophosphoryl lipid A (MPL). It was designed to elicit both high-titer neutralizing antibodies and a robust Th1-type cellular immune response. In a large-scale Phase 3 clinical trial (the Herpevac Trial) involving over 8,000 women, the vaccine demonstrated approximately 58% efficacy against genital herpes disease caused by HSV-1 but failed to provide significant protection against HSV-2, the primary cause of genital herpes. Due to this lack of efficacy against HSV-2, GSK discontinued the development of the vaccine for this indication.

Brand names
Simplirix
Other names
HerpevacgD-Alum/MPL vaccinegD2-AS04 vaccinegD-2-AS04 vaccinegD 2-AS04 vaccineHSV-2 gD2 vaccineHSV2 gD2 vaccineHSV 2 gD2 vaccine
02

Targets

Herpes simplex virus 2 glycoprotein D-specific B-cell receptor (HSV-2 gD-specific BCR)Herpes simplex virus type 2 glycoprotein D-specific T-cell receptorTLR4 (Toll-like receptor 4)gD (HSV-2 glycoprotein D)

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