The US Food and Drug Administration (FDA) has granted a Fast Track designation for GSK plc’s Neisseria gonorrhoeae investigational vaccine (NgG).
The vaccine candidate is currently in an ongoing phase II trial and aims to demonstrate proof of concept by assessing the efficacy of the NgG vaccine in healthy adults, 18 to 50 years of age, considered at risk of gonorrhea. Fast Track designation is intended to facilitate the development and expedite the review of potentially important new drugs and vaccines to treat or prevent serious conditions with unmet medical needs.
Gonorrhea is the second most prevalent bacterial sexually transmitted infection (STI) worldwide, with an estimated 82 million new cases globally each year. In the U.S., rates of reported gonorrhoea have increased 118% from 2009 to 2021, resulting in 710,151 cases being reported to the US Centers for Disease Control and Prevention (CDC) in 2021.
Phil Dormitzer, global head of vaccines R&D at GSK, said: “We welcome the FDA’s decision to grant Fast Track designation for our new vaccine candidate against Neisseria gonorrhoeae infection. With a high and growing incidence, gonorrhea is a major concern for sexual and reproductive health around the globe. This designation recognises the potential for a vaccine that could help protect millions of people across the world against the serious health consequences of infection with a bacterium that is considered a ‘high priority’ pathogen by the World Health Organisation.”
Antimicrobial resistance (AMR) to gonorrhea has increased over the past 80 years, rendering many classes of antibiotics used to treat the disease ineffective. Vaccines can play a critical role in the fight against AMR by helping prevent bacterial, viral and other infections. At this time, there are no gonorrhea vaccines approved anywhere in the world.
GSK phase I/II trial
The trial conducted by GSK is a phase I/II first time in human study (FTiH) evaluating the vaccine candidate’s safety and efficacy in individuals aged 18-50 years old, regardless of previous gonorrhea history.
Phase I of the study was a FTiH dose-escalation safety lead-in conducted in healthy adults and is now complete. Phase II of the study is ongoing and aims to demonstrate Proof of Concept by assessing the efficacy of the NgG vaccine in healthy adults considered at risk of gonorrhea.
The trial started in November 2022, and approximately 750 subjects will be enrolled from eight countries (U.S., U.K., France, Germany, Spain, Brazil, the Philippines, and South Africa).
Gonorrhea is recognized as an urgent unmet medical need due to its growing global incidence and reduced efficacy of available treatments as drug-resistant strains are increasing. Ng infection in women is often asymptomatic and under-diagnosed. When left untreated, Ng infection can lead to complications and long-term consequences such as pelvic inflammatory disease, infertility, ectopic pregnancy, and adverse pregnancy outcomes. Painful symptoms in men make gonorrhoea more likely to be diagnosed, but stigma surrounding the disease is still a barrier to seeking diagnosis and treatment. It has also been shown that Ng infections may also increase the risks of acquiring or transmitting HIV.