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GSK’s gonorrhea vaccine receives fast-track designation to expedite clinical trials
Nature Medicine explores the latest translational and clinical research news, with a fast-track designation for a vaccine against sexually transmitted infection with Neisseriagonorrhoeae.
On 27 June 2023, GSK’s vaccine candidate to prevent gonorrhea was granted fast-track designation by the US Food and Drug Administration. This followed positive safety results from the phase 1 portion of their phase 1/2 trial, which started in November 2022, paving the way for their phase 2 trial of around 750 people 18–50 years of age. The trial includes men and women considered at risk of infection with the bacterium Neisseriagonorrhoeae in eight countries: the USA, the United Kingdom, France, Germany, Spain, Brazil, the Philippines and South Africa. Participants are split into three groups: those who received the highest tolerated dose in the phase 1 trial; those receiving a dose below the highest tolerated dose; and those who receiving placebo. The primary outcome is local and systemic adverse events, and hematological and biochemical abnormalities. Gonorrhea cases up to 13 months after vaccination will be a closely watched secondary endpoint.
