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

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

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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

What to watch in microbicide research in 2015…

Data from FACTS 001 Trial2

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

FACTS001 and your communities

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

What to watch in vaccine research in 2015…

HVTN 100 Continues AIDS Vaccine Research and Development

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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

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

Other notable developments to watch in 2015…

Launch of the ECHO trial3

Continuation of the Early-Treatment “Cure” Strategy Trial in Infants

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Ebola Vaccine Trials10

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