STI Vaccine development
genital herpes is an incurable viral infection that can have painful symptoms and may triple risk for HIV.
Both preventive and therapeutic genital herpes simplex virus (HSV) vaccines are being explored, and scientists generally agree that development of these vaccines should be feasible. Previous preventive vaccine candidates did not demonstrate high efficacy in Phase 3 trials. However, new products are under development.
More than 500 million people aged 15 to 49 years are estimated to have a genital herpes infection.
Genital herpes infection can cause painful genital sores and can triple a person’s risk of acquiring HIV. In rare cases, genital herpes can also be transmitted during pregnancy or delivery, which may lead to infant death or severe neurological disabilities.
Genital herpes is incurable, but antiviral medications can prevent or improve symptoms and help prevent transmission to others.
A number of therapeutic vaccine candidates have entered clinical trials in recent years, including one led by Sanofi Pasteur, Immune Trial Design, PATH and NIAID that is expected to report results in mid-2024.
Researchers have also conducted modeling studies demonstrating that both types of vaccine could have significant public health and economic impact, including reduction of HIV infections and savings of hundreds of millions of dollars in healthcare costs.
WHO has published preferred product characteristics to help ensure potential preventive and/or therapeutic genital herpes vaccines will best meet public health needs, especially in low- and middle-income countries. This document notes that while therapeutic vaccines may be easier to develop and would have some important benefits, a preventive vaccine would be ideal, because:
- Only a relatively small proportion of people with genital herpes have symptoms and seek care
- Even if their symptoms are suppressed, people with genital herpes infection remain at increased risk for HIV acquisition
- A preventive vaccine would be more straightforward to administer within existing immunization infrastructure, for example by delivery to all adolescent girls and boys
The WHO document also identifies preferred characteristics for each type of vaccine, including vaccine indications, target populations, type of vaccine administration, delivery strategies efficacy requirements, duration of protection, schedule, and safety requirements.
WHO preferred product characteristics for herpes simplex virus vaccines. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO.
Spicknall IH, Looker KJ, Gottlieb SL, et al. Review of mathematical models of HSV-2 vaccination: Implications for vaccine development. Vaccine. 2019 Nov 28;37(50):7396-7407. doi: 10.1016/j.vaccine.2018.02.067. Epub 2018
Gottlieb SL, Giersing B, Boily MC, et a.; WHO HSV Vaccine Impact Modelling Meeting Working Group. Modelling efforts needed to advance herpes simplex virus (HSV) vaccine development: Key findings from the World Health Organization Consultation on HSV Vaccine Impact Modelling. Vaccine. 2019 Nov 28;37(50):7336-7345. doi: 10.1016/j.vaccine.2017.03.074. Epub 2017 Jun 21.
Johnston C, Gottlieb SL, Wald A. Status of vaccine research and development of vaccines for herpes simplex virus. Vaccine. 2016 Jun 3;34(26):2948-2952. doi: 10.1016/j.vaccine.2015.12.076. Epub 2016 Mar 11.