STI vaccines are a major priority for sustainable global STI control. Large number of infections globally

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1 Brisbane, 4 Sept 05 STI are a major priority for sustainable global STI control Preliminary WHO estimates: 357 million new cases of curable STIs in 0 The global roadmap for STI : Moving forward Large number of infections globally Adverse outcomes including HIV risk, infertility, pregnancy complications 8 million 3 million 4 million Sami Gottlieb, MD, MSPH World Health Organization Limitations of existing interventions Safe, highly efficacious against HPV and HBV have been major s 64 million 63 million 39 million Source: WHO, unpublished data. Curable STIs: chlamydia, gonorrhea, syphilis, trichomoniasis Prevalent HSV- estimates: 47 million infections globally in 0 70 million 30 million 35 million 3 million 75 million 8 million Adverse outcomes Syphilis: >300,000 fetal and neonatal deaths per year HPV causes >500,000 cases cervical cancer annually Chlamydia and gonorrhea important causes of infertility, ectopic pregnancy HSV- increases HIV risk by 3-fold Genital symptoms and psychosocial consequences have important effects on quality of life Current control challenges Limits to progress made with condom promotion Most infections asymptomatic and lack of feasible tests in many settings Screening programs difficult to bring to scale Antimicrobial resistance: drug-resistant gonorrhea Little public policy attention: without simple intervention, harder to garner support Source: WHO, Looker unpublished et al, PLoS ONE, data

2 7 Current control challenges Limits to progress made with condom promotion Most infections asymptomatic and lack of feasible tests in many settings Screening programs difficult to bring to scale Antimicrobial resistance: drug-resistant gonorrhea Little public policy attention: without simple intervention, harder to garner support 7 Highlight need for continued work toward STI 8 STI vaccine technical consultation and special issue of Vaccine, March 04 8 Need, status, and future prospects for STI : HSV Chlamydia Gonorrhea Syphilis Trichomoniasis Global roadmap for STI vaccine Available at: 9 Global roadmap for STI Consensus based on discussions at consultation Critical next steps from pre- through vaccine introduction 9 Discovery Discovery Preclinical stage 0

3 Discovery Clinical Preclinical stage Science & Tech Push Pull Push and pull forces Funding Push Pull STI Disease burden Market STI Moving forward: better epidemiologic data Update global STI estimates 05: HSV- published; HSV-, curable STIs under review; neonatal herpes underway HSV- added to GBD Study 03, ongoing updates Continued efforts to improve methods, increase data Leverage existing but non-published STI data STIMA: individual participant data meta-analysis Combined data from 8 prospective HIV prevention studies Over 37,000 women in Africa; >95% with STI data Consider: HPV vaccine, circumcision, contraception trials Seek opportunities to add STI variables to future studies STI

4 Moving forward: STI vaccine modelling HSV vaccine modelling meeting, March 05, reviewed existing models and outlined new modelling needs Inclusion of HIV incidence, neonatal herpes, HSV- Better primary data on neonatal herpes, costs in LMICs Modelling in different epidemiologic/income settings New chlamydia vaccine modelling efforts Owusu-Edusei et al, 05: suggested a successful chlamydia vaccine could be cost-effective Update as s 9 STI 0 NIH/NIAID workshops Specialized working groups to facilitate collaboration among academics, industry, government Standardized reagents, immunogens, assays Consensus on most appropriate animal models Strategies for how to accelerate moving vaccine candidates into clinical Chlamydia vaccine workshop, May 05 Gonorrhea vaccine workshop, June 05 STI WHO preferred product characteristics (PPCs) Process to reach consensus on characteristics of meeting priority public health goals for low- and middleincome countries (LMICs) Guidance to product developers early in R&D Ensure LMICs will benefit from future vaccine Increase industry confidence in larger global market Shape target s Types of characteristics Prophylactic vs therapeutic Prevention of morbidity vs infection Target population Efficacy requirements Safety and acceptability considerations 3 4 4

5 PD-VAC committee HSV vaccine on agenda, presented at September 05 PD-VAC meeting Discussed how WHO could facilitate Consensus building on possible role of in pipeline in LMICs, clinical trial endpoints, PPCs How to obtain better data on neonatal herpes in LMICs Updated modelling efforts STI Single document pulling together many aspects of roadmap to: Guide investment Inform decision-making Outline public health rationale

6 Vaccine process Vaccine process Vaccine process Market demand - Competing interventions Market demand - Competing interventions Return on investment Current status of the pathway of STI Thank you! Basic Research Trichomonas vaginalis Treponema pallidum Preclinical Development Neisseria gonorrhoeae Chlamydia Research Tools and trachomatis Technologies Clinical Evaluation Herpes simplex virus Nathalie Broutet Carolyn Deal Gitte Giersing Helen Rees STI Vaccine Technical Consultants Follow us on Visit our website who.int/reproductivehealth