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Sanofi’s Chlamydia Vaccine Candidate Granted Fast Track Designation by FDA

Following a promising pre-clinical program, Sanofi is planning a phase 1/2 randomized, clinical study.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

The US Food and Drug Administration (FDA) has granted fast track designation to Sanofi’s mRNA vaccine candidate for the prevention of chlamydia infection. The decision was based on the potential of the vaccine candidate to address a serious condition and address an unmet public health need.

The chlamydia vaccine candidate is designed to protect against primary genital tract infection and reinfection by the bacterium Chlamydia trachomatis. Following a promising pre-clinical program, Sanofi is planning a phase 1/2 randomized, clinical study designed to evaluate the immunogenicity and safety of the chlamydia vaccine candidate in adults aged 18 to 29 years. The study is due to start in the coming days.

Jean-François Toussaint, Global Head of Vaccines R&D, said, “Millions of people currently live with undiagnosed chlamydia, including asymptomatic infection that can also cause severe long-term health effects if left untreated. Antibiotics to treat chlamydia have not been successful in controlling rising infection rates. With our program, we aim to make chlamydia a preventable disease through vaccination.”

The development of this vaccine candidate is part of the Translational Science Hub, a partnership with the Queensland Government, Griffith University, and the University of Queensland.

More Sanofi News

Sanofi and Johnson & Johnson recently discontinued the E.mbrace phase 3 study for a vaccine candidate against extraintestinal pathogenic E. coli.

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