FDA Fast-Tracks mRNA Vaccine Candidate

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The U.S. Food and Drug Administration (FDA) has fast-tracked an mRNA vaccine candidate for chlamydia.

“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,” a press release from Sanofi read.

“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,” it continued.

“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,” Jean-François Toussaint, global head of vaccines R&D, stated.

Per Sanofi:

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.

From Drug Topics:

The current recommended treatment includes doxycycline 100 mg orally twice daily for 7 days. Alternative treatment could include a single dose of azithromycin 1 g orally or levofloxacin 500 mg orally once daily for 7 days.

The vaccine candidate is aimed at protecting against primary genital tract infection and reinfection by Chlamydia trachomatis, and it will be evaluated in a phase 1/2 randomized clinical trial for patients aged 18 to 29 years. The trial will evaluate the immunogenicity and safety of the candidate.

The study (NCT06891417) will also include 3 sentinel cohorts and a main cohort, with the former assessing the safety of different doses. Patients included in the study will be followed up to 12 months after the last intervention, according to the clinical trial data. Investigators will include patients aged 18 to 29 who have a new sexual partner within the past 6 months, more than 1 current sexual partner, or a partner with a known previous or coexisting STI. Additionally, there will be 14 experimental treatment groups and 2 placebo groups.

The primary end points included the presence of immediate unsolicited systemic adverse events (AEs), solicited injection site and systemic reactions, unsolicited AEs, medically attended AEs, all serious AEs, AEs of special interest, fatal serious AEs, and out-of-range biologic test results. Secondary outcomes will include the assessment of serum binding antibodies specific to chlamydia and the geometric mean cell-mediated immune response of antigen-specific T helper type 1 and type 2 cells.



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