On September 11 local time, British pharmaceutical company GSK announced that it would halt the development of its herpes simplex virus (HSV) vaccine, which failed to pass the TH HSV REC-003 study and will not proceed to Phase 3 research.TH HSV REC-003 is a combined Phase I/II study designed to evaluate the potential clinical efficacy of GSK3943104.At the same time, GSK announced the primary objective data analysis of the phase 2 portion of the TH HSV REC-003 trial, which is conducted in two parts:- The first part evaluates the reactogenicity, safety, immune response, and efficacy of the HSV vaccine in healthy volunteers aged 18 to 40.
- The second part evaluated the reactogenicity, safety, immune response, and efficacy of the HSV vaccine in participants aged 18-60 with recurrent HSV-2 genital herpes.
According to the clinicaltrials website, the study involved a total of 342 patients. ApproximatelyA total of 245 healthy volunteers aged 18-40 will participate in the first part of the study, and approximately 87 participants aged 18-60 with recurrent HSV-2 genital herpes will participate in the second part. Two-thirds of the participants in the second part (approximately 58 people) will receive two doses of the HSV vaccine, while one-third will receive two doses of a placebo.TH HSV REC-003 Study to Continue Routine Safety Monitoring and Collect Follow-up Data, Potentially Offering Valuable Insights into the Management of Recurrent Genital Herpes. GSK is Coordinating with Researchers to Communicate the Trial Results to Participants.Given the unmet medical needs associated with genital herpes, innovation in this field remains necessary. GSK intends to comprehensively evaluate all data to advance the future research and development of its HSV program.In the HSV vaccine field, Moderna and BioNTech are still actively promoting vaccine development. Moderna's injectable mRNA-1608 vaccine is currently undergoing Phase I/II studies in the United States. The first fully enrolled human Phase I/II trial of the mRNA-1608 vaccine aims to test the vaccine's safety and immunogenicity, with two more Phase III trials expected to be conducted in 2024.In addition, BioNTech is also developing an HSV vaccine named BNT163, which entered phase one trials in December 2022.Reference: GSK official website
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