State of the Field Exploring 2015’s Top Ten List for the HIV Prevention Research Field Manju...
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![Page 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.](https://reader036.fdocuments.in/reader036/viewer/2022062515/56649cd85503460f949a08e3/html5/thumbnails/1.jpg)
State of the Field
Exploring 2015’s Top Ten List for the HIV Prevention Research Field
Manju Chatani, Stacey Hannah, Mitchell Warren
Thursday, January 29th, 2015
![Page 2: State of the Field Exploring 2015’s Top Ten List for the HIV Prevention Research Field Manju Chatani, Stacey Hannah, Mitchell Warren Thursday, January.](https://reader036.fdocuments.in/reader036/viewer/2022062515/56649cd85503460f949a08e3/html5/thumbnails/2.jpg)
![Page 3: State of the Field Exploring 2015’s Top Ten List for the HIV Prevention Research Field Manju Chatani, Stacey Hannah, Mitchell Warren Thursday, January.](https://reader036.fdocuments.in/reader036/viewer/2022062515/56649cd85503460f949a08e3/html5/thumbnails/3.jpg)
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
4
![Page 4: State of the Field Exploring 2015’s Top Ten List for the HIV Prevention Research Field Manju Chatani, Stacey Hannah, Mitchell Warren Thursday, January.](https://reader036.fdocuments.in/reader036/viewer/2022062515/56649cd85503460f949a08e3/html5/thumbnails/4.jpg)
PrEP studiesNon-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 studyNon-tenofovir-based pill regimens, e.g., Maraviroc• Ongoing Phase II studies
Long-acting injectables• Two Phase II studies beginning early 2015
![Page 5: State of the Field Exploring 2015’s Top Ten List for the HIV Prevention Research Field Manju Chatani, Stacey Hannah, Mitchell Warren Thursday, January.](https://reader036.fdocuments.in/reader036/viewer/2022062515/56649cd85503460f949a08e3/html5/thumbnails/5.jpg)
What to watch in microbicide research in 2015…
Data from FACTS 001 Trial2
![Page 6: State of the Field Exploring 2015’s Top Ten List for the HIV Prevention Research Field Manju Chatani, Stacey Hannah, Mitchell Warren Thursday, January.](https://reader036.fdocuments.in/reader036/viewer/2022062515/56649cd85503460f949a08e3/html5/thumbnails/6.jpg)
FACTS 001Phase III trial of 1% tenofovir gel (BAT24 dosing)2600 women in South AfricaResults expected early 2015 (CROI)Critical confirmatory research after the results of CAPRISA 004
![Page 7: State of the Field Exploring 2015’s Top Ten List for the HIV Prevention Research Field Manju Chatani, Stacey Hannah, Mitchell Warren Thursday, January.](https://reader036.fdocuments.in/reader036/viewer/2022062515/56649cd85503460f949a08e3/html5/thumbnails/7.jpg)
FACTS001 and your communities
What are you thinking about FACTS 001 results?Will they affect your communities?Your trials?What are your engagement strategies?
![Page 8: State of the Field Exploring 2015’s Top Ten List for the HIV Prevention Research Field Manju Chatani, Stacey Hannah, Mitchell Warren Thursday, January.](https://reader036.fdocuments.in/reader036/viewer/2022062515/56649cd85503460f949a08e3/html5/thumbnails/8.jpg)
What to watch in vaccine research in 2015…
HVTN 100 Continues AIDS Vaccine Research and Development
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![Page 9: State of the Field Exploring 2015’s Top Ten List for the HIV Prevention Research Field Manju Chatani, Stacey Hannah, Mitchell Warren Thursday, January.](https://reader036.fdocuments.in/reader036/viewer/2022062515/56649cd85503460f949a08e3/html5/thumbnails/9.jpg)
RV14431% 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
ThailandPhase IIIALVAC/AIDSVAXClade A/E
RV306
HVTN 113
HVTN 107
ThailandPhase I & IIALVAC/AIDSVAXClade A/EReboost of RV144 participants
Q3 2013
Southern AfricaPhase I/II
MF59 vs. alum adjuvantsClade C
Southern AfricaPhase I/II
DNA, ProteinClade C
Southern Africa, USPhase I/II
DNA, Protein, MF59-AS01B adjuvantClade C
Southern Africa, Switzerland, USPhase I/II
DNA, NYVAC, Protein/MF59-AS01B adjuvantClade C
Possible start Q1 2018
Southern AfricaPhase I/II
DNA, ALVAC, Protein, MF59-AS01B adjuvantClade C
Start Q2 2015
StartQ2 2015
StartQ3 2015
Start Q4 2015
StartQ4 2015
Analysis of samples & correlates of risk
(2009 – 2014)
RV305
Q1 2012
Southern AfricaPhase IIb
Efficacy study of down-selected vaccine regimens
Clade C
South AfricaPhase I/IIALVAC/gp120/MF59 adjuvantClade C
South AfricaPhase IIALVAC/AIDSVAXClade A/E
HVTN 100
Start Q1 2015
HVTN 702
Start Q4 2016
HVTN 097
Q2 2013-2014
South AfricaPhase IIIALVAC/gp120/MF59 adjuvantClade 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
![Page 10: State of the Field Exploring 2015’s Top Ten List for the HIV Prevention Research Field Manju Chatani, Stacey Hannah, Mitchell Warren Thursday, January.](https://reader036.fdocuments.in/reader036/viewer/2022062515/56649cd85503460f949a08e3/html5/thumbnails/10.jpg)
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
![Page 11: State of the Field Exploring 2015’s Top Ten List for the HIV Prevention Research Field Manju Chatani, Stacey Hannah, Mitchell Warren Thursday, January.](https://reader036.fdocuments.in/reader036/viewer/2022062515/56649cd85503460f949a08e3/html5/thumbnails/11.jpg)
Other notable developments to watch in 2015…
Launch of the ECHO trial3
Continuation of the Early-Treatment “Cure” Strategy Trial in Infants
5
Ebola Vaccine Trials10