Griffith University

PARIS, France I March 26, 2025 I The US Food and Drug Administration 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 has been 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 coming days. Jean-François Toussaint Global Head of Vaccines R&D “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.” Chlamydia, caused by the bacterium Chlamydia trachomatis, is a common bacterial infection of the reproductive tract with consequences for developing infertility and pregnancy complications. In 2020, there were 129 million worldwide cases of chlamydia among adults (15-49 years old), with the highest rates of infection among adolescents and young adults. Although chlamydia can be treated with antibiotics when diagnosed, over 80% of chlamydia cases are asymptomatic, meaning there is a significant risk that infections go unrecognized, leading to untreated cases and unintentional transmission. Programs that have been put in place to prevent infection rates from rising have proven insufficient, highlighting the urgent public health need for a vaccine. 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, connecting world-class researchers in Queensland, Australia, with Sanofi scientists in France and the US. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. SOURCE: Sanofi

Paris: The US Food and Drug Administration (FDA) has granted Fast Track designation to Sanofi ’s mRNA vaccine candidate for the prevention of chlamydia infection , addressing a critical public health need for which no licensed vaccine currently exists. The investigational vaccine is designed to protect against primary genital tract infection and reinfection caused by the bacterium Chlamydia trachomatis and has undergone a preclinical program. The vaccine development program is part of the Translational Science Hub (TSH), a partnership with the Queensland Government, Griffith University, and the University of Queensland. This initiative connects world-class researchers in Queensland, Australia, with Sanofi scientists in France and the U.S. “Millions of people currently live with undiagnosed chlamydia, including asymptomatic infections that can cause severe long-term health effects if left untreated. Antibiotics have not been successful in controlling rising infection rates. With our program, we aim to make chlamydia a preventable disease through vaccination,” said Jean-François Toussaint, Global Head of Vaccines R&D at Sanofi. In the coming days, the French drugmaker plans to initiate a Phase 1/2 randomized clinical study to evaluate the immunogenicity and safety of the chlamydia vaccine candidate in adults aged 18 to 29 years. Chlamydia, caused by Chlamydia trachomatis, is a common bacterial infection of the reproductive tract and can lead to infertility and pregnancy complications. According to the company, in 2020, there were 129 million cases of chlamydia worldwide among adults aged 15–49 years, with the highest infection rates reported among adolescents and young adults. Although Chlamydia is treatable with antibiotics, asymptomatic individuals—who account for over 80 per cent of total cases—remain at risk of undertreatment or unintentional transmission. By Online Bureau ,

There is currently no FDA-approved vaccine for the prevention of chlamydia infection. Image credit: Shutterstock / Wirestock Creators. 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. 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. mRNA vaccine coverage on Pharmaceutical Technology (or Clinical Trials Arena) is supported by Trilink . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Enhance your mRNA production with market leading capping Optimising mRNA production raises myriad questions for biomanufactures around how to navigate costs and maximise efficiency. TriLink BioTechnologies has leveraged its expertise to provide answers. Their CleanCap® M6 analog improves mRNA yields and boosts protein expression. With its newly optimised pulse-feed protocol, manufacturers can double production at just a fraction of the cost. As a proven solution in scalable IVT reactions, CleanCap® M6 ensures consistent quality and reduced costs for mRNA production. Download now to learn more. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Trilink Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Trilink Thematic and that your personal data will be used as described in their Privacy Policy