Bharat Biotech to lead phase 3 trials of promising Shigella vaccine

Bharat Biotech has partnered with GSK to advance the Shigella vaccine altSonflex1-2-3. With strong early trial results and no safety concerns, Bharat Biotech will now lead phase 3 trials, regulatory processes, and manufacturing for use in low-income countries.

Hyderabad: Bharat Biotech International Limited on Thursday announced a partnership with pharma multinational GSK for the development and potential deployment of the Shigella vaccine candidate ‘altSonflex1-2-3’.

The agreement marks a significant step in advancing the promising vaccine, which targets Shigellosis — a severe form of bacterial diarrhea that disproportionately affects children under five years of age, according to a press release.

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The vaccine candidate ‘altSonflex1-2-3’, developed by GSK, has shown encouraging results in early-stage clinical trials. A Phase 1 study in Europe demonstrated a favourable safety profile and a strong immune response. Subsequent Phase 2 trials in Africa, including vaccination of 9-month-old infants — the primary target population — reported no safety concerns. Interim results from 2024 confirmed that the candidate met its pre-set immunogenicity goals, the statement said.

Dr. Krishna Ella, Executive Chairman of Bharat Biotech, said, “With no approved vaccine currently available and antimicrobial resistance on the rise, there is an urgent need for scalable, science-backed solutions focused on low and middle-income countries.”

As part of the agreement, Bharat Biotech will lead further development of altSonflex1-2-3, including Phase 3 clinical trials, regulatory submissions, and large-scale manufacturing.