Table of Contents
- Trial overview
- Who participated
- Study design and phase
- What the researchers measured
- Trial status and size
- What this means for patients
Trial overview
The main study of GSKVX000000030810 looked at reactogenicity, safety, immune response, and efficacy in people with herpes simplex.[1] The trial was designed to study a targeted immunotherapy against HSV in both healthy adults and adults with recurrent genital herpes.[1]
The study also aimed to see whether the treatment could reduce the risk of confirmed HSV-2 recurrent genital herpes episodes.[1]
Who participated
The trial included healthy participants aged 18 to 40 years and participants aged 18 to 60 years with recurrent genital herpes.[1] This means the study looked at both people without active disease and people who already had repeated genital herpes outbreaks.[1]
Study design and phase
This was an interventional study, which means researchers gave study treatments and then measured the results.[1] The trial was in Phase 1/2, an early stage of research that usually checks safety first and then begins to look for signs that the treatment may work.[1]
The study was completed and included 515 participants.[1]
What the researchers measured
The researchers measured short-term local reactions after each dose, including redness, pain, and swelling at the administration site.[1] They also measured short-term whole-body reactions, such as fever, fatigue, headache, muscle pain, and joint pain.[1]
They tracked unsolicited adverse events, which are unwanted medical problems that were not specifically asked about, for 28 days after each dose.[1] They also tracked medically attended events, serious adverse events, and immune-mediated diseases for up to 12 months after the last study treatment.[1]
The study checked blood and chemistry test results for laboratory abnormalities after dose 1 and dose 2, with different time points listed for Part I and Part II.[1] For the efficacy part of the study, researchers measured the time to the first confirmed HSV-2 recurrent genital herpes episode.[1]
Trial status and size
The trial NCT05298254 is listed as completed.[1] It enrolled 515 participants in total.[1]
What this means for patients
These trials are early research studies, so their main goal is to learn whether GSKVX000000030810 can be given safely and whether it may help people with recurrent genital herpes.[1] The study does not only look at possible benefit; it also carefully checks for reactions after treatment and for longer-term safety problems.[1]
Because the study included both healthy adults and adults with recurrent genital herpes, the researchers could compare safety and immune response across different groups.[1]
