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GSK and Bharat Biotech to Advance Shigella Vaccine into Phase 3 Trials

Bharat Biotech leads late-stage development, manufacturing, regulatory submissions with GSK supporting trial design, funding, global access planning.

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Overview

  • altSonflex1-2-3 uses GSK’s Generalized Modules for Membrane Antigens technology to deliver O antigens via bacterial outer membranes for high-yield, cost-effective production.
  • Phase 1 trials in Europe and Phase 2 trials in Africa, including nine-month-old infants, showed strong safety and immunogenicity with no adverse safety signals.
  • Bharat Biotech will oversee Phase 3 clinical trials alongside regulatory filings and scale-up manufacturing for global distribution.
  • This collaboration builds on a 2021 product transfer and license agreement between GSK and Bharat Biotech for the RTS,S malaria vaccine.
  • Shigellosis currently has no licensed vaccine and causes severe gastrointestinal illness worldwide, making this candidate a key public health priority.