1. Pox-Protein Public-Private Partnership (P5)
Established in 2010 to build on the RV144 results
Seeks to advance and ultimately license HIV pox-protein vaccine candidates that have the potential to achieve a broad public health impact
The Phase III HIV Vaccine Trial, also known as RV144, was the largest HIV vaccine study ever conducted in humans and involved more than 16,000 volunteers in Thailand. The trial tested a “prime-boost” combination of two vaccines and provided first evidence that an HIV vaccine is possible

2. Strategy includes Licensure & Research Tracks
LICENSURE TRIAL: Thailand
Population: MSM, high-risk
Products: ALVAC (Sanofi Pasteur) + gp120/adjuvant
Partners/Funders: US Army, Thai Gov’t, NIH, Sanofi Pasteur, BMGF
RV144 FOLLOW-UP: Thailand
Research Studies:
RV144i immune correlates studies
RV305 protein boost -subset from RV144
RV306 expanded immunogenicity of RV144 regimen
RV328 AIDSVAX B/E study
Partners/Funders: US Army, Thai Gov’t, NIH, Sanofi Pasteur, BMGF
LICENSURE TRIAL: South Africa
Population: Heterosexual, high-risk
Products: ALVAC (sanofi pasteur) + gp120/MF59 (Novartis)
Partners/Funders: NIH, HVTN, Sanofi Pasteur, Novartis, BMGF
RESEARCH TRIAL
Population: Heterosexual, high-risk
Products: DNA + NYVAC (sanofi pasteur) + protein/adjuvant (such as MF59)
versus
NYVAC (sanofi pasteur) + protein/adjuvant
Ad26/MVA
Partners/Funders: NIH, HVTN, Sanofi Pasteur, Novartis, BMGF

3. Next Steps
The P5 has initiated the multi-step development process for vaccine components:
Includes vector and immunogen development activities, production of clinical lots, preclinical studies and safety characterizations
P5 is concurrently working on:
Regulatory planning and access agreements
Collaborating with government and communities within the host countries

4. Scientific Objective of Phase 1-2 Trial in Southern Africa
To demonstrate immune responses from clade C vaccine sufficient to extend results of RV144 vaccine
To determine if levels of V1V2 antibody responses to clade C vaccine will enable testing of the V1V2 hypothesis as a vaccine-induced Correlate of Protection (CoP)

5. SOUTHERN AFRICAN COUNTRIES
Total: 6
N# OF SITES
Total: 30
South Africa 20
Mocambique 2
Botswana
Zimbabwe 3
Zambia
Malawi
HIV incidence in
South African women: 3.5-9%
men: %
G. Gray

6. Cape Town HIV Vaccine Laboratory: ~10,000 ft2 Facility
Stronger lab infrastructure is needed in-country to support these large-scale studies, particularly for conducting cellular endpoint analyses and exploratory mucosal studies.
The Cape Town laboratory will open in July 2013, with funding from:
BMGF- $3 million for renovations of the space and lab equipment
NIH/DAIDS (HVTN grant)- additional equipment and operating budget
Aeras- agreement under negotiation to share space and expenses
Laboratory projects:
Phase I
-Investigate cellular endpoint studies in vaccine trials.
-Establish training center for young laboratory investigators and laboratory staff involved in South African clinical trials.
Phase II
-Support combination HIV prevention and non-HIV vaccine studies in Southern/Eastern Africa.
-Facilitate career development of lab scientists who can assume future leadership roles in infectious disease clinical research.
J McElrath