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 fast track pathway is designed to expedite the development and review of drugs for certain medical conditions where there is currently an unmet need. Pharmaceutical companies are eligible for benefits, including more frequent meetings with the FDA and faster review times.
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Sanofi’s vaccine is designed to protect against primary genital tract infection and reinfection by the bacterium Chlamydia trachomatis, which is responsible for the most common sexually transmitted bacterial infection in the world.
Treatment for the infection currently includes a regimen of antibiotics, although there are no pharmacological options to prevent the disease. Sanofi stated that health programmes initiated to prevent infection rates from rising have proven insufficient, highlighting the public health need for a vaccine. The consequences of infection in women are more serious than in men, given that pelvic inflammatory diseases can arise, a complication that can lead to infertility.
Sanofi is developing the vaccine in partnership with the Queensland government, Griffith University, and the University of Queensland, all based in Australia. The vaccine has produced a “promising pre-clinical programme”, according to the drugmaker.
A Phase I/II randomised clinical study, which is slated to start in the coming days, will evaluate the immunogenicity and safety of the candidate in adults aged 18 to 29 years. Sanofi has remained tight-lipped on further details of the vaccine, saying only that it is mRNA-based.
Sanofi has various mRNA vaccines in development for infectious diseases, including respiratory syncytial virus (RSV), influenza, and meningitis, among others.
Sanofi’s global head of vaccine research and development Jean-François Toussaint 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 programme, we aim to make chlamydia a preventable disease through vaccination.”
A separate vaccine candidate has already demonstrated positive results in a randomised Phase I trial (NCT03926728). Funded by the EU Horizon programme, researchers from the UK and Denmark reported in The Lancet Infectious Diseases that their candidate was safe and induced an immune response in adults. The research team have earmarked a larger Phase II trial.
There are already a handful of vaccines approved to prevent certain sexually transmitted infections, including HPV and hepatitis B.
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