Herpes Simplex Viruses (HSV-1/2) are ubiquitous members of the human herpes family and are transmitted by oral/genital contact. Both viruses cause lifelong genital infections (GUD*) and HSV-1 can also cause oral/ocular/CNS infections. Although most individuals infected with HSV-1/2 have minimal signs of infection, persons with GUD can experience frequent disease reactivation which has a considerable impact on sexual reproductive health, wellbeing, and disease transmission. Neonatal herpes, although rare, can have devastating consequences for the new-born infant with a mortality rate of ~60-85%. The WHO has estimated that 491m persons in 2016 were living with HSV-2 globally (15-49 yrs) which is 13.2% prevalence in this age group (James CJ et al 2020). In the same study, HSV-1 was estimated to be prevalent in 3.7 bn people worldwide in 2016. HSV-2 is also a significant contributor to global HIV incidence, especially in low-income countries where 25-50% of HIV infections are estimated to be attributable to HSV-2 (Looker KJ et al 2020).
Antiviral treatments e.g., acyclovir/valacyclovir are available for HSV infections and are used to prevent symptomatic disease, improve quality of life, and suppress the virus to prevent transmission to sexual partners. However, given the substantial global prevalence of HSV and its contribution to the HIV epidemic and other health conditions, the World Health Organisation has stressed that the development of immunological approaches is warranted (2019 PPC paper). A prophylactic HSV vaccine [PX] to prevent disease acquisition and a therapeutic [TX] vaccine for reduction of symptomatic disease (GUD) are both proposed.
Recent work into mechanisms of HSV pathogenesis and a greater understanding of vaccine-induced immunity to latent pathogens has given renewed confidence to the HSV vaccine development field. Researchers believe there are rational explanations behind the past high-profile failures of previous prophylactic and therapeutic approaches i.e., GSK’s Simplirix (gD-2/AS04) and Genocea’s GEN-003/Agenus HerpV. New mRNA-focused vaccine competitors such as ModernaTX (mRNA-1608) and BioNTech [UPENN] are now involved with HSV vaccines at the preclinical level along with a range of biotechs using various platform technologies. GSK has recently initiated a Phase 1/2 study [NCT05298254] with GSK3943104A exploring different formulations of a potential adjuvanted subunit therapeutic approach. The company had previously terminated a SAM-based approach, GSK4108771A in 2021.
VacZine Analytics has recently conducted two brand new analyses focused on developments in both prophylactic and therapeutic HSV vaccines. A global commercial forecast for both approaches to 2040 is provided across major Western, and for the PX approach, GAVI African markets. The scenario-based interplay of various target product profiles (TPPs) is examined with a thorough review of the latest epidemiological/impact studies and discussion of vaccinology/new R&D strategies with a focus on next-generation concepts. A competitor landscape is also provided with a discussion of the merits of mRNA approaches. Both opportunities are compared in terms of feasibility and commercial potential making these studies an ideal platform for client internal decision making/prioritization.
Both MarketVIEW products consist of a detailed Executive presentation (>175 .pdf slides) and a comprehensive MS-Excel workbook forecast model (.xls)
*Genital Ulcer Disease
Photo credit(s): Prince Akachi, Mateus Campos Felipe [Both on Unsplash]
VacZine Analytics® is a strategic research agency based in the United Kingdom since 2007. We aim to provide disease and commercial analysis for the vaccine industry and help build the case for developing new vaccines and biologics.
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