A study investigating GSK’s investigational herpes simplex virus (HSV) vaccine candidate failed to meet its primary efficacy endpoint.
The TH HSV REC-003 trial (ClinicalTrials.gov Identifier: NCT05298254) was a phase 1/2 study that evaluated the reactogenicity, safety, immune response, and efficacy of GSK3943104, an HSV-targeted immunotherapy in individuals aged 18 to 60 years with recurrent genital herpes (RGH).
Study participants were randomly assigned to receive 2 doses of the non-adjuvanted HSV vaccine or placebo intramuscularly on days 1 and 29. The primary efficacy endpoint was the time to first confirmed HSV-2 RGH episode, defined as at least 1 of the lesional or anogenital swabs taken during the suspected episode being positive for HSV-2 as measured by polymerase chain reaction.
According to the Company, an analysis of data from the phase 2 portion of the trial showed the primary efficacy objective had not been met. As such, GSK has decided not to advance the vaccine candidate to a phase 3 trial. The TH HSV REC-003 is expected to continue in order to monitor for safety and to generate additional data; no safety concerns have been observed thus far.
By Diana Ernst, RPh
References:
GSK provides update on phase I/II therapeutic herpes simplex virus (HSV) vaccine trial. News release. GSK. September 11, 2024. https://www.gsk.com/en-gb/media/press-releases/gsk-provides-update-on-therapeutic-herpes-simplex-virus-hsv-vaccine-trial/.
Source : MPR
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