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Pox-Protein Public-Private Partnership (P5) Established in 2010 to build on the RV144 results Seeks to advance and ultimately license HIV pox- protein.

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Presentation on theme: "Pox-Protein Public-Private Partnership (P5) Established in 2010 to build on the RV144 results Seeks to advance and ultimately license HIV pox- protein."— Presentation transcript:

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 1

2 2 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 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 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 LICENSURE TRIAL: Thailand Population: MSM, high-risk Products: ALVAC (Sanofi Pasteur) + gp120/adjuvant 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 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 versus Ad26/MVA 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 versus 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 3

4 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 Africa20 Mocambique2 Botswana2 Zimbabwe3 Zambia2 Malawi2 HIV incidence in South African women: 3.5-9% men: % G. Gray

6 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. Cape Town HIV Vaccine Laboratory: ~10,000 ft 2 Facility J McElrath


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