The US Food and Drug Administration (FDA) has granted a Fast Track designation to GSK plc Neisseria gonorrhoeae investigational vaccine (NgG).
The vaccine candidate is currently in ongoing phase II trials and aims to demonstrate a proof of concept by assessing the efficacy of the NgG vaccine in healthy adults, aged 18 to 50 years, who are considered at risk for gonorrhea. Fast Track designations are intended to facilitate the development and expedite the review of new drugs and vaccines that are potentially important for treating or preventing serious conditions with unmet medical needs.
Gonorrhea is the second most common bacterial sexually transmitted infection (STI) worldwide, with an estimated 82 million new cases globally each year. In the US, reported rates of gonorrhea have increased 118% from 2009 to 2021, resulting in 710,151 cases reported to the US Centers for Disease Control and Prevention (CDC) in 2021.
Phil Dormitzer, head of global vaccines R&D at GSK, said: “We welcome the FDA’s decision to grant Fast Track designation to our new vaccine candidate Neisseria gonorrhoeae infection. With a high and increasing incidence, gonorrhea is a major concern for sexual and reproductive health worldwide. This designation recognizes the potential for vaccines to help protect millions of people worldwide against the serious health consequences of bacterial infections that are considered ‘high priority’ pathogens by the World Health Organization.”
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 an important role in fighting AMR by helping prevent bacterial, viral and other infections. Currently, there is no approved gonorrhea vaccine anywhere in the world.
GSK phase I/II trials
The trial by GSK is the first phase I/II human study (FTiH) to evaluate the safety and efficacy of a vaccine candidate in individuals aged 18-50 years, regardless of previous history of gonorrhea.
The Phase I study of the safety guidance of increasing the dose of FTiH performed in healthy adults has now been completed. Phase II of this study is ongoing and aims to demonstrate a Proof of Concept by assessing the efficacy of the NgG vaccine in healthy adults who are considered to be at risk for gonorrhea.
The trial starts in November 2022, and around 750 subjects will be enrolled from eight countries (USA, UK, France, Germany, Spain, Brazil, Philippines and South Africa).
Gonorrhea is recognized as an urgent unmet medical need due to increasing global incidence and reduced efficacy of available treatments as drug-resistant strains increase. Ng infection in women is often asymptomatic and underdiagnosed. 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 gonorrhea more likely to be diagnosed, but the stigma surrounding the disease remains a barrier to seeking diagnosis and treatment. It has also been shown that Ng’s infection can also increase the risk of contracting or transmitting HIV.