Gates Package — page 418

Select Recent Highlights NIH-Bill & Melinda Gates Foundation Cooperation • Efficacy studies of two HIV vaccines moving forward o The P5 vaccine efficacy study (HVTN 702), which launched in November 2016 in South Africa, is the first HIV vaccine efficacy study in 7 years o The Imbokodo (HVTN 705) study, which launched in November 2017, is a Phase 2b proof-of-concept study evaluating the safety and efficacy of a Ad26 mosaic vaccine and Clade C gp140. The vaccine regimen is based on "mosaic" immunogens -- vaccine components designed to induce immune responses against a wide variety of global HIV strains. • Evaluation of a novel, long acting injectable antiviral for HIV Prevention o In November 2017, launched Phase III efficacy study (HPTN 084) to compare long-acting cabotegravir to daily Truvada for pre-exposure prophylaxis in HIV-uninfected women. • TB Drug development and clinical endpoints o NIAID intramural collaborations with BMGF have contributed to novel clinical markers for treatment response (PET/CT, NexGenNCT02371681) that are now further evaluated in the "PREDICT TB" trial (NCT02821832) to identify patients who may benefit from shortened therapy. o NIAID intramural, in collaboration with pharmaceutical partners (GSK, Merck) through the BMGF funded "TB Drug Accelerator" are co-developing novel anti-TB agents that are now entering clinical evaluation. o NIAID extramural programs are continuing to contribute to the establishment of best practices and preclinical/clinical evaluation of new drug candidates that are advanced through BMGF funded PDPs. • Single-dose HPV vaccine o In early November, NCI participated in high-level meetings at the Gates Foundation to discuss ongoing efforts to evaluate single-dose protection of the HPV vaccines. o If the hypothesis that one dose can confer strong protection is verified by the results of the trial, these results should enable this approach to be the standard of care and greatly increase HPV vaccination uptake - which currently stands at around 3% of eligible girls in LMICs - throughout the world. o In late November, the new Costa Rica Vaccine Trial ("ESCUDDO") started-- the first girls have now been immunized. o Additional studies planned to complement Costa Rica Trial; one immunogenicity study built to harmonize with the Costa Rica trial has already been initiated. • Contraception o A comprehensive analysis of publicly available gene expression and protein expression data has been performed to identify reproductive-tract specific transcripts/proteins to serve as potential non-hormonal targets for male and/or female contraceptive development. o A web-based contraceptive target database containing all pertinent information is in development for public access with a beta version released early to mid-2018.