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Drug intelligence / Profile preview
trivalent P2-VP8 subunit rotavirus vaccine
- Development stage
- Phase 3
- Lead developer
- PATH
- Modality
- Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
- 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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