FDA Grants Fast Track Designation to mRNA Vaccine Candidate for Chlamydia
Currently, there is no vaccine to prevent chlamydia, but treatment includes regimens of antibiotics, including doxycycline, azithromycin, and levofloxacin.
The FDA granted fast track designation to an mRNA vaccine candidate for the prevention of chlamydia infection.1
Currently, there is no vaccine to prevent chlamydia, but treatment includes regimens of antibiotics, including doxycycline, azithromycin, and levofloxacin. | Image Credit: littlewolf1989 | stock.adobe.com
“Millions of people currently live with undiagnosed chlamydia, including asymptomatic infection that can also cause severe long-term health effects if left untreated,” Jean-François Toussaint, global head of vaccine research and development at Sanofi, said in a news release.1 “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 was the most frequently reported bacterial infectious disease in the United States in 2021, according to the CDC, with the prevalence being highest for patients 24 years and older. Because asymptomatic infection is common, detection with screening is necessary, with annual screening being recommended for all sexually active women less than 25 years old and women 25 years and older who have a new sexual partner, more than 1 partner, a partner with a sexually transmitted infection (STI), or a partner with concurrent partners.2
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.2
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.1
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.3
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.3
According to an article from Pharmaceutical Technology, the vaccine is being developed in partnership with the Queensland government, Griffith University, and the University of Queensland in Australia. Other information on the vaccine has not been released; however, Sanofi has stated that the chlamydia vaccine candidate was designed as an mRNA vaccine.4
READ MORE: Immunization Resource Center
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