Drug intelligence / Profile preview

trivalent P2-VP8 subunit rotavirus vaccine

Development stage
Phase 3
Lead developer
PATH
Modality
Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

Trivalent P2-VP8 subunit rotavirus vaccine is an investigational **intramuscular, non-replicating recombinant protein-subunit vaccine** intended to prevent severe rotavirus gastroenteritis in infants. It contains recombinant VP8 subunits derived from human rotavirus strains DS-1 P[4], 1076 P[6], and Wa P[8], each fused to the tetanus-toxoid P2 helper-T-cell epitope and adsorbed to aluminum hydroxide. PATH led development with SK bioscience as a commercial-development partner. Although the candidate was safe and immunogenic in clinical studies, its pivotal Phase 3 trial was stopped early after interim and final analyses found inferior protection against severe rotavirus gastroenteritis relative to oral Rotarix. ([pmc.ncbi.nlm.nih.gov](https://pmc.ncbi.nlm.nih.gov/articles/PMC7482676/))

Other names
TV P2-VP8trivalent P2-VP8trivalent rotavirus P2-VP8 subunit vaccineP2-VP8-P[4/6/8]
02

Targets

VP4 (Rotavirus VP4)

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