Satellite Sessions

08:30 – 12:00

HIV Vaccine Efficacy Trials: What does it take?

08:30 – 10:30

Non-Neutralizing Antibodies: Linking Adaptive and Innate Immunity

10:30 – 13:00

Recent Advances in Humanized Mice to Speed HIV Vaccine Development

11:30 – 13:30

Demystifying the Process: The Role of the Canadian HIV Vaccine Initiative in Moving an HIV Vaccine from Pre-Clinical to Clinical Stages

13:00 – 15:00

Efficacy Trials in Design: A Global Perspective

13:30 – 15:30

Treatment as Prevention: "The New Vaccine for AIDS?"

13:30 – 16:00

Antibody Gene Transfer for HIV Immunoprophylaxis

15:00 – 16:00

Motivators and Barriers to HIV Vaccine Trials

14:00 – 17:00

HIV Vaccine Trials in the PrEP Era

14:00 – 17:00

Capacity Building for HIV Vaccine Trials: The Results of 6 EDCTP Projects

HIV Vaccine Efficacy Trials: What does it take?

Westin Hotel, Grand Ballroom A

Open Session

Host Institutions: the Global HIV Vaccine Enterprise, AVAC, Fenway Health, the Harvard Center for AIDS Research, HIV Vaccine Trials Network, International AIDS Vaccine Initiative, U.S. Military HIV Research Program, NIAID, Ragon Institute and USAID

Session Chairs: Margaret McCluskey, USAID

This session is intended to provide a general overview for our conference, community and journalist scholars and other interested participants of the latest advances in the field and necessary steps to move a vaccine concept into a trial and onward toward licensure.  The session will feature two case studies looking at what comes after an efficacy signal, the many issues along the difficult road to licensure (the RV144 trial) as well as the steps and considerations to plan and execute a phase IIB trials, using HVTN 505 as an example.

Non-Neutralizing Antibodies: Linking Adaptive and Innate Immunity

Westin Hotel, Grand Ballroom C

Open Session
Host Institutions: Thayer School of Engineering, Dartmouth College
Session Chairs: Guido Ferrari and Margaret Ackerman

The induction of neutralizing antibody (NAb) and cytotoxic T lymphocyte (CTL) responses ha s been a long-standing target for HIV-1 vaccine development. However, neither NAbs nor CTLs has thus far correlated with protection against HIV-1 infection in human vaccine clinical trials.

More recently, the phase III efficacy trial of a prime–boost combination of vaccines containing ALVAC-HIV (vCP1521) and AIDSVAX B/E has offered the first evidence of vaccine-induced partial protection in humans. The most recent data obtained from the correlates of risk analyses in the RV144 case-control study indicated that non-NAbs, including anti-V1/V2 binding Abs, inversely correlated with risk of infection. Moreover, a low risk of infection was found for subjects who had both low anti-Env IgA responses and high ADCC Ab responses directed against infected cells. These data suggest that non-NAb responses, and ADCC Abs among those, could be a component of the immune response contributing to protection from infection. Their investigation faces old and new challenges that will be discussed in this session.

10:30 – 13:00

Recent Advances in Humanized Mice to Speed HIV Vaccine Development

Westin Hotel, Grand Ballroom B

Open Session
Host Institutions: Ragon Institute of MGH, MIT, and Harvard and Harvard Medical School
Session Chairs: Andrew M. Tager and Todd M. Allen

Efforts to determine how to best induce or augment human immune responses to HIV would be greatly facilitated by the availability of a small animal model supportive of HIV infection. The recent generation of humanized BLT (bone marrow, liver, thymus) mice has now dramatically improved the ability of mice to support human immune systems that exhibit HIV-specific cellular and humoral immune responses that mirror those of HIV-infected subjects. Here we will discuss recent important advances in HIV infection in humanized mice and the potential for this model to significantly advance HIV vaccine development.

11:30 – 13:30

Demystifying the Process: The Role of the Canadian HIV Vaccine Initiative in Moving an HIV Vaccine from Pre-Clinical to Clinical Stages

Westin Hotel, Grand Ballroom C

Open Session
Host Institutions: The Canadian HIV Vaccine Initiative (CHVI) - Government of Canada and the Alliance Coordinating Office

The objectives are to discuss the vaccine development process from the perspective of the researcher and make linkages on how the CHVI can facilitate the process from early pre-clinical studies to actual delivery.

The session will include a panel of CHVI-funded researchers and CHVI representatives to discuss various tools, approaches, and lessons learned in the following areas:

• Community engagement and regulatory considerations in the HIV vaccine research and development process;

• Integration of basic, clinical and social sciences throughout the vaccine discovery and development process; and

Enhancing capacity building efforts (laboratory, CT and regulatory) in low and middle income countries.

13:00 – 15:00

Efficacy Trials in Design: A Global Perspective

Westin Hotel, Grand Ballroom D

Open Session

Host Institutions: HVTN, Fred Hutchinson Cancer Research Center

Session Chair: Larry Corey

The RV144 HIV vaccine efficacy trial demonstrated that a recombinant canarypox vector boosted with a gp120 conferred 31% efficacy against HIV acquisition compared to placebo. Multiple stakeholders have formed the Pox Protein Public Private Partnership (P5) to build on these results and extend them to other regions of the world. Other vaccine platforms are also in the planning stages for evaluating efficacy along similar timelines as the P5. Several studies are in development, and phase 1/2 studies are expected to begin in 2013, with the potential for a pivotal phase III study and research phase IIb comparisons thereafter in southern Africa, Thailand, and China. This satellite session will update the HIV vaccine community on these various activities and provide a venue for dialogue regarding upcoming efficacy trials.

13:30 – 15:30

Treatment as Prevention: "The new vaccine for AIDS?"

Westin Hotel, Grand Ballroom E

Open Session
Host Institutions: GAIA Vaccine Foundation, Providence RI and Bamako, Mali
Session Chairs: Anne S. De Groot M.D. (GAIA Vaccine Foundation, University of Rhode Island, and EpiVax, Inc.), Jon Cohen (Science Magazine), Paul Loberti (Office of HIV/AIDS & Viral Hepatitis, Rhode Island)

Is development of an HIV vaccine truly necessary? At this session we will discuss the potential for implementation of the "Treatment as Prevention" (TasP) approach to ending AIDS, in the absence of an effective vaccine. Speaker Julio Montaner is a forceful advocate for TasP, promoting expanded access to ARVs to reduce HIV transmission as early as 2006. Speaker Myron Cohen coordinated the landmark study HPTN 052 study demonstrating that TasP effectively prevents HIV transmission; individuals starting TasP early were 96% less likely to transmit the virus to their sexual partners than those who started TasP later. Jon Cohen (Science Magazine), Paul Loberti (RI) and Anne S. De Groot will chair the session. Paul Loberti, Jon Cohen, Myron Cohen, and Julio Montaner were the GAIA Hope is a Vaccine Award winners, 2011. For more information on this session: http://www.GAIAVaccine.org.

13:30 – 16:00

Antibody Gene Transfer for HIV Immunoprophylaxis

Westin Hotel, Grand Ballroom A

Open Session
Host Institution: The Foundation for Vaccine Research
Session Chairs:  Stanley Plotkin, Beatrice Hahn

The purpose of this special satellite symposium is to present and discuss the state of gene delivery technologies and their application to prevent HIV infection. The program will feature state-of-the-art talks by Phil Johnson, David Baltimore, Dennis Burton, Pamela Bjorkman, Michael Farzan, Michel Nussenzweig, followed by an open floor discussion.  The talks will focus primarily on AAV delivery of genes encoding for potent, broadly neutralizing antibodies and DNA constructs encoding for antibody-like molecules in human subjects for the purpose of expressing functional proteins for the prevention of HIV infection.  The topic of gene delivery of antibodies is not being covered in the main conference program. 

15:00 – 16:00

Motivators and barriers to HIV vaccine trials

Westin Hotel, Grand Ballroom C

Open Session
Host Institution: University of British Columbia
Session Chairs: Dr. Shayesta Dhalla, MD, MHSc, PhD

In our previous published work (Dhalla & Poole), we have reviewed motivators (2011) and barriers (2011) to participation in hypothetical phase 3 HIV vaccine trials.  Appealing to motivators and barriers of participation in HIV vaccine trials is important for recruitment and enrollment purposes in early phase and phase 3 HIV vaccine trials.  The proposed agenda is: 1) 20 minutes: an analysis of hypothetical and actual motivators and barriers to participation using powerpoint presentation 2) 20 minutes: discussion of further motivators and barriers as identified by session participants 3) brainstorming ways to ways to address motivators and barriers during recruitment phases.

14:00 – 17:00

HIV Vaccine Trials in the PrEP Era

Westin Hotel, Carlton Room

Open Session

Host Institution: Fred Hutchinson Cancer Research Center

Session Chairs: Susan Buchbinder and Scott Hammer

Antiretroviral (ARV) drugs administered systemically or topically as pre-exposure prophylaxis (PrEP) have shown partial efficacy against sexually acquired HIV-1 infection in several randomized controlled clinical trials. Many questions remain regarding methods to maximize adherence and optimize the timing, route, and frequency of dosing. As ARVs are licensed for  PrEP indications and uptake of PrEP evolves in diverse populations, vaccine trials will need to be designed to evaluate the impact of PrEP use on vaccine safety and efficacy.  Strategies should be developed to optimize the prevention impact of combinations of partially effective HIV interventions, while assessing the individual contribution of prevention components, including vaccines.  The science, trial design, ethical, and community impact of conducting such combination prevention trials will be explored in this symposium.

14:00 – 17:00

Capacity Building for HIV Vaccine Trials: The Results of 6 EDCTP Projects

Westin Hotel, Burroughs Room

Open Session
Host Institutions: European and Developing Countries Clinical Trials Partnership (EDCTP), Bill & Melinda Gates Foundation
Session Chairs: Pauline Beattie and Siobhan Malone

The European and Developing Countries Clinical Trials Partnership (EDCTP) and the Bill & Melinda Gates Foundation launched a joint call for proposals in late 2006 to establish or strengthen clinical trial site capacity in preparation for the conduct of preventive HIV vaccine trials. Six applicants were selected for funding including four based in sub-Saharan Africa and two in Europe. Capacity development of clinical trial sites and the conduct of clinical trials took place in Tanzania, Mozambique, South Africa, Kenya, Gambia, Uganda, Malawi, Burkina Faso and Kenya. The results of this € 24M investment will be presented by the six project leads.