1. State of the Field Exploring 2015’s Top Ten List for the HIV Prevention Research Field Manju Chatani, Stacey Hannah, Mitchell Warren Thursday, January 29 th, 2015

3. What to watch in PrEP research in 2015… Launch of two Phase II Long- Acting Injectable ARV Trials Data from IPERGAY and PROUD PrEP Trials 1 1 4 4

4. PrEP studies Non-daily or “on-demand” oral TDF/FTC Interim data analysis from IPERGAY showed “on- demand” Truvada (taken before and after sex) effective; data expected at CROI Daily Truvada for gay men in the UK – PROUD study Non-tenofovir-based pill regimens, e.g., Maraviroc Ongoing Phase II studies Long-acting injectables Two Phase II studies beginning early 2015

5. What to watch in microbicide research in 2015… Data from FACTS 001 Trial 2 2

6. FACTS 001 Phase III trial of 1% tenofovir gel (BAT24 dosing) 2600 women in South Africa Results expected early 2015 (CROI) Critical confirmatory research after the results of CAPRISA 004

7. FACTS001 and your communities What are you thinking about FACTS 001 results? Will they affect your communities? Your trials? What are your engagement strategies?

8. What to watch in vaccine research in 2015… HVTN 100 Continues AIDS Vaccine Research and Development 6 6

9. RV144 31% efficacy What’s next for the Pox-Protein Public-Private Partnership (P5) 2012 2013 2014 2015 2016 2017 2018 P5 (2003 – 2009) Thai Efficacy Trial Possible Possible start 2018 (?) HVTN 111 HVTN 108 HVTN 109 HVTN 701 Thailand Phase III ALVAC/AIDSVAX Clade A/E RV306 HVTN 113 HVTN 107 Thailand Phase I & II ALVAC/AIDSVAX Clade A/E Reboost of RV144 participants Q3 2013 Southern Africa Phase I/II MF59 vs. alum adjuvants Clade C Southern Africa Phase I/II DNA, Protein Clade C Southern Africa, US Phase I/II DNA, Protein, MF59-AS01B adjuvant Clade C Southern Africa, Switzerland, US Phase I/II DNA, NYVAC, Protein/MF59-AS01B adjuvant Clade C Possible start Q1 2018 Southern Africa Phase I/II DNA, ALVAC, Protein, MF59-AS01B adjuvant Clade C Start Q2 2015 Start Q2 2015 Start Q3 2015 Start Q4 2015 Start Q4 2015 Analysis of samples & correlates of risk (2009 – 2014) RV305 Q1 2012 Southern Africa Phase IIb Efficacy study of down-selected vaccine regimens Clade C South Africa Phase I/II ALVAC/gp120/MF59 adjuvant Clade C South Africa Phase II ALVAC/AIDSVAX Clade A/E HVTN 100 Start Q1 2015 HVTN 702 Start Q4 2016 HVTN 097 Q2 2013-2014 South Africa Phase III ALVAC/gp120/MF59 adjuvant Clade C Down-selection from these Phase I/II trials In 2009, the RV144 Thai vaccine trial provided the first evidence in humans that a safe and effective preventive HIV vaccine is possible. Although efficacy was 31.2% at the end of the study, there was a higher early effect (60%) at 12 months. The Pox-Protein Public- Private Partnership (P5) is a diverse group of organizations committed to building on the success of the RV144 trial and evaluating potentially improved pox-protein vaccines to determine if they might provide significant public health benefit. Licensure Track Research Track Series of trials designed, as a whole, to lead to a product submitted for regulatory approval and eventual public health introduction Conduct a set of harmonized Phase I trials of priming and boosting regimens, evaluate for immunologic potency, potential correlates of protection and eventually down- select to compare best in Phase I/II for efficacy

10. P5 research agenda What are the key community concerns or interests around vaccine trials and vaccine development more broadly? What key issues should we be thinking about with regard to a possible efficacy trial in Southern Africa in 2017? E.g. PrEP introduction, gel and ring results, implications for other clades/regions

11. Other notable developments to watch in 2015… Launch of the ECHO trial 3 3 Continuation of the Early- Treatment “Cure” Strategy Trial in Infants 5 5 Ebola Vaccine Trials 10

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