Transcript Document

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…
1
Data from IPERGAY and PROUD
PrEP Trials
4
Launch of two Phase II LongActing Injectable ARV Trials
PrEP studies
Non-daily or “on-demand” oral TDF/FTC
• Interim data analysis from IPERGAY showed “ondemand” 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
What to watch in microbicide
research in 2015…
2
Data from FACTS 001 Trial
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
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…
6
HVTN 100 Continues AIDS Vaccine
Research and Development
What’s next for the Pox-Protein Public-Private Partnership (P5)
2012
RV144
31% efficacy
(2003 – 2009)
RV305
Analysis of samples
& correlates of risk
Q1 2012
(2009 – 2014)
P5
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 PublicPrivate 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.
2013
2014
2015
2016
2017
2018
Possible
Thai Efficacy
Trial
RV306
Q3 2013
Thailand
Phase I & II
ALVAC/AIDSVAX
Clade A/E
Reboost of RV144
participants
Possible start
2018 (?)
HVTN 097
HVTN 100
HVTN 702
Q2 2013-2014
Start Q1 2015
Start Q4 2016
Licensure Track
Series of trials
designed, as a
whole, to lead to
a product
submitted for
regulatory
approval and
eventual public
health
introduction
Research Track
Conduct a set of
harmonized
Phase I trials of
priming and
boosting
regimens,
evaluate for
immunologic
potency,
potential
correlates of
protection and
eventually downselect to
compare best in
Phase I/II for
efficacy
South Africa
Phase II
ALVAC/AIDSVAX
Clade A/E
South Africa
Phase I/II
ALVAC/gp120/MF59 adjuvant
Clade C
Southern Africa
Phase I/II
MF59 vs. alum adjuvants
Clade C
HVTN 107
Southern Africa
Phase I/II
DNA, Protein
Clade C
HVTN 111
South Africa
Phase III
ALVAC/gp120/MF59 adjuvant
Clade C
Start
Q2 2015
Start
Q2 2015
Southern Africa, US
Phase I/II
DNA, Protein, MF59-AS01B adjuvant
Clade C
HVTN 108
Southern Africa, Switzerland, US
Phase I/II
DNA, NYVAC, Protein/MF59-AS01B adjuvant
Clade C
HVTN 109
Southern Africa
Phase I/II
DNA, ALVAC, Protein, MF59-AS01B adjuvant
Clade C
Thailand
Phase III
ALVAC/AIDSVAX
Clade A/E
Start
Q4 2015
HVTN 113
Start
Q3 2015
Start
Q4 2015
Down-selection
from these
Phase I/II
trials
HVTN 701
Possible start
Q1 2018
Southern Africa
Phase IIb
Efficacy study of down-selected
vaccine regimens
Clade C
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…
3
Launch of the ECHO trial
5
Continuation of the EarlyTreatment “Cure” Strategy Trial in
Infants
10
Ebola Vaccine Trials
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