GSK Halts Herpes Vaccine After Poor Phase I/II Results

GSK has announced the discontinuation of its early-stage herpes simplex virus (HSV) vaccine development after the investigational shot, named GSK3943104, failed to meet the primary efficacy objective in a key study. The pharmaceutical company revealed on Wednesday that it would not advance the vaccine to Phase III trials following the TH HSV REC-003 proof-of-concept study's disappointing results.

The company did not specify which efficacy metric was not met, only indicating that the primary efficacy objective was not achieved. Despite this setback, GSK confirmed that the study identified no safety concerns associated with the vaccine candidate.

Acknowledging the significant medical needs and challenges faced by individuals with herpes simplex virus, GSK stated its commitment to continue gathering safety and follow-up data from the TH HSV REC-003 study. The insights from this data collection could provide valuable information on recurrent genital herpes and guide future research and development in GSK's HSV program.

On its website, GSK's pipeline page indicates that the company currently has no other candidates for HSV. The TH HSV REC-003 study was a randomized, observer-blinded trial divided into two parts. The first part included healthy volunteers aged 18 to 40, while the second part involved patients aged 18 to 60 with recurrent genital herpes. According to clinicaltrials.gov, the trial tested three different formulations of the vaccine candidate, with or without an adjuvant, against a placebo. A total of 342 participants were enrolled in the study.

The primary outcome of the study was to measure the proportion of participants experiencing specific administration site events, such as pain, redness, and swelling within seven days following the first vaccine dose, and again after the second dose administered on day 29. Additionally, the study assessed systemic effects, including fever, fatigue, headaches, and muscle pain.

Beyond safety outcomes, the study also sought signs of efficacy for the vaccine candidate, particularly in terms of preventing confirmed HSV-2-related recurrent genital herpes episodes. HSV is a widespread infection that often presents without symptoms or only mild ones. In more severe cases, it can cause painful, recurring blisters, and newly acquired infections can lead to symptoms such as fevers, body aches, and swollen lymph nodes. As of now, there are no available cures or vaccines for HSV.

While GSK is stepping back from its HSV vaccine development, other companies are making strides in this area. Moderna is advancing an HSV vaccine with its mRNA-based shot, mRNA-1608, which is currently undergoing a Phase I/II study in the U.S. BioNTech is also working on an HSV vaccine, named BNT163, which entered its first-in-human Phase I trial in December 2022.

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