Chlamydia is a sexually transmitted infection caused by the bacterium Chlamydia trachomatis. Most people who are infected have no symptoms and therefore do not seek treatment, which can lead to serious complications. It is widely thought that mucosal immunity plays a critical role in protecting against chlamydia, and as such, BlueWillow’s intranasal nanoemulsion (NE) vaccine is uniquely suited to offer protection against this concerning infection.
Chlamydia is one of the most commonly reported sexually transmitted diseases in the United States and globally. According to the Centers for Disease Control and Prevention, an estimated 3 million infections occur annually. Often referred to as a “silent” infection, estimates suggest over 75% of women with chlamydia have no symptoms and therefore do not seek treatment. If untreated, a significant percentage of women develop pelvic inflammatory disease (PID) that can lead to lifelong complications including infertility, ectopic pregnancies and chronic pelvic pain. Untreated chlamydia also increases the likelihood of acquiring or transmitting HIV.
Currently, there is no vaccine to prevent the spread of chlamydia.
BlueWillow’s nanoemulsion (NE) adjuvant is uniquely suited to enable vaccines for sexually transmitted infections, wherein pathogens enter the body across mucosal surfaces. When used with intranasal vaccination, the NE adjuvant elicits both mucosal and systemic immunity. The mucosal immunity elicited by NE vaccines provides critical protection against these infections at their port of entry.
In recent pre-clinical studies conducted under a collaboration with researchers at the Queensland University of Technology (QUT) in Brisbane Australia, mice received three administrations of an intranasal NE vaccine and were then subsequently challenged intra-vaginally with chlamydia. The study’s principal endpoint measured oviduct pathology as an indicator of PID. 100% of mice receiving no treatment developed oviduct pathology in the study versus 20% of mice receiving the NE vaccine (p<0.001). In addition, animals that received the NE vaccine generated high levels of both serum and vaginal antibodies (IgG and IgA), strong IL-17 and interferon gamma responses, and had faster clearing of the bacteria, as compared to the no treatment control arm.
In 2018, NIH awarded BlueWillow an SBIR Phase I grant to conduct additional challenge studies in mice using an intranasal vaccine combining the company’s NE adjuvant with a novel chlamydia antigen developed by Dr. James Mahony at McMaster University in Ontario, Canada. Activities under the grant are currently ongoing.