Press Release

Report Warns Flat Funding for HIV Prevention Research May Limit Ability of Researchers to Move Promising Approaches Forward

VIENNA (21 July, 2010) – Following significant advances in vaccine and microbicide research, importantly including results presented today of 39% efficacy in the CAPRISA 004 microbicide gel trial among women in South Africa, a new report released today warns that flat funding for HIV prevention research may limit researchers’ ability to quickly move promising approaches forward.

The report examines investment in HIV prevention research in 2009 and finds that the onset of a global recession did not immediately impact funding levels for biomedical HIV prevention research.  Total funding remained stable at approximately US$1.165 billion for preventive vaccines, microbicides, pre-exposure prophylaxis (PrEP) and operations research related to male circumcision.

In the face of an economic crisis that has deeply affected the economies and public-sector budgets of HIV prevention research funders, level funding for HIV prevention is cause for cautious optimism. Yet much of the 2009 funding was likely reflective of resources committed when the global economy was far healthier. As current funding commitments come to an end, the concern will be whether funders will be able to renew commitments at existing funding levels. Furthermore, the report authors argue that flat funding of HIV prevention research could have serious consequences for the field as results from critical prevention trials move the research agenda forward. They warn that researchers could have insufficient resources to advance important opportunities to prevent HIV.

Advancing the Science in a Time of Fiscal Constraint: Funding for HIV Prevention Technologies in 2009, the sixth annual report from the HIV Vaccines and Microbicides Resource Tracking Working Group, was released today at the XVIII International AIDS Conference in Vienna, Austria.  It documents investments in biomedical HIV prevention research from public, philanthropic and commercial sectors in 2009. HIV vaccines continued to receive the majority of funding, with a total of US$868 million, which was equal to 2008 funding levels. Investment in microbicides was US$236 million, a decline of 3 percent from 2008 levels. Funding for oral pre-exposure prophylaxis (PrEP) increased by 18 percent over 2008 levels to US$52 million.

The stability in funding is encouraging, given a 10 percent decrease in funding for AIDS vaccine research seen in 2008, but the Working Group identified several areas of concern if funding remains flat, including escalating costs of late-stage clinical research, dependency on a small group of funders and a lack of diversity in funders. In addition, the Working Group stresses that the CAPRISA 004 results, while tremendously exciting, are by no means the definitive answer about antiretroviral-based microbicides and appropriately resourced confirmatory and exploratory research will be needed.

The Working Group has documented an overall trend since 2000 toward increased funding of new funders joining in the effort to support HIV prevention research. Yet in 2009, this funding stability was largely the result of increased or sustained funding by the U.S. National Institutes of Health and the Bill & Melinda Gates Foundation, which together accounted for 79 percent of vaccine funding, 59 percent of microbicide funding and 70 percent of PrEP funding.

“With five new infections, for every two people newly on treatment we cannot give up our quest for new HIV prevention tools,” said Michel Sidibé, Executive Director of UNAIDS. “Investments for HIV prevention must be enhanced and sustained.”

“As we push for expanded funding and political commitments for HIV prevention research and the overall AIDS response, we must also work to find smart and innovative ways to make the best use of available funding to continue to scale up delivery of existing interventions and to look for new ones,” said Mitchell Warren executive director of AVAC. “HIV prevention researchers, advocates and donors must all commit to working together to ensure that we make the best and smartest use of limited resources, while also ensuring that the most promising interventions continue to move forward.”

Recent and upcoming results from several major studies could radically change the trajectory of HIV prevention research and increase the need for funding. These include the results of the RV144 Thai AIDS vaccine trial, which showed modest protection against HIV and scientifically demonstrated for the first time that an AIDS vaccine was possible, results from an important proof of concept microbicide trial CAPRISA 004, released yesterday at the Vienna AIDS conference, and anticipated results from two PrEP trials in the coming year.

“This is a very exciting time in HIV prevention research,” said Seth Berkley, President and CEO of the International AIDS Vaccine Initiative. “As the prevention research field is primed to exploit scientific advances availability and flexibility of funding will be critically important.  Our ability to move discoveries into and to undertake even the most critical of these large-scale trials is at risk in the current funding environment.”

 “We must work to continuously ensure resources are available to fulfill the promise of new scientific advances that could save millions of lives,” said Dr. Zeda Rosenberg, CEO of the International Partnership for Microbicides.  “Microbicides, PrEP, vaccines and treatment-as-prevention are just beginning to show great promise for HIV prevention in large-scale trials.  As we work together to develop these tools and transform our global health goals into reality, our success depends on having sufficient resources to keep pace with research developments in the field.” 

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Press Release

Study of Microbicide Gel Shows Reduced Risk of HIV & Herpes Infections in Women

“This is a historic day for HIV prevention research. The CAPRISA 004 results are the first clinical evidence that a microbicide gel can help to prevent sexual transmission of HIV infection,” said AVAC Executive Director Mitchell Warren, reacting to the results of the landmark microbicide trial presented today at the International AIDS Conference in Vienna.

“We believe that the most responsible plan of action now is to quickly and efficiently articulate the sequence of steps necessary for confirmation and follow-up of these results, while also aggressively planning for potential roll-out of a licensable product.”

“It will take time and resources to fully analyze and understand the data, but this proof of concept demands immediate action both in South Africa where there are a range of key, context-specific issues—and on a global level where this new evidence will energize and redirect the microbicide field as well as the broader arena of prevention strategies based on anti-HIV drugs. Simultaneous efforts on many fronts are needed to eventually realize the public health potential suggested by these data.”

“We congratulate the trial sponsors, scientific collaborators, and partners who conducted this trial, and especially want to thank the nearly 900 South African women whose altruism and commitment as trial volunteers made this effort possible. These volunteers and their communities have made an inestimable contribution to HIV prevention research and to the eventual development of new ways for women and men all over the world to protect themselves from HIV. We owe them an enormous debt of gratitude,” Warren said.

“As we move forward in our search for microbicides and other new HIV prevention options, researchers will need the collaboration of tens of thousands more men and women around the world in additional trials. Right now, the VOICE trial is working in four countries, including South Africa, to evaluate both 1% tenofovir gel and oral pre-exposure prophylaxis—this study is more important than ever, as are additional trials that have yet to be planned.”

As the trial team reported in Vienna today, CAPRISA 004 provided the first evidence that the use of the antiretroviral (ARV) drug tenofovir in the form of a vaginal gel can reduce the risk of HIV infection in women. The overall rate of effectiveness reported in the trial was 39 percent. The “test of concept” trial tested the effectiveness of 1% tenofovir gel, used before and after sex, among urban and rural South African women at high risk of HIV via vaginal sex.

“These results move us one step closer to finding much needed new HIV prevention options for women and men,” said Warren. “We look forward to working with the field to further examine the great wealth of data this trial has produced. These data will help guide decisions about further studies needed as well as provide important information to help design implementation programs if additional research indicates that we have a licensable product.”

AVAC calls on the trial sponsors, researchers, funders and others in the field to work quickly, and cooperatively to boldly to translate these findings into development of a scientific action plan to attempt to confirm these results and answer other outstanding questions. Such a plan must be well resourced and swiftly implemented, and it must ensure that additional supplies of tenofovir gel can be quickly manufactured to meet the needs of follow-up studies.

“As exciting as this result is—and as important as it is to follow it up without delay—the reality is that this product will not be available for widespread introduction tomorrow. Its critical to manage expectations while maintaining urgency. This challenging but necessary work falls on the shoulders of all stakeholders involved in AIDS prevention and treatment. At the same time, we must ensure that all stakeholders reaffirm their commitments to work that will lead to eventual access to effective microbicides for everyone who needs them,” Warren said.

Additional relevant information will also come from the ongoing research on other, related antiretroviral-based prevention strategies in HIV negative people. These include trials of pre- exposure prophylaxis, or PrEP, which is evaluating the use of oral ARVs to reduce HIV risk in HIV negative people. There is also one other ongoing effectiveness trial known as MTN 003, or VOICE, that is evaluating daily use of 1% tenofovir gel (a different dosing strategy from CAPRISA 004) along with oral use of tenofovir or tenofovir/emtricitabine. The positive finding from CAPRISA 004 increases hope that there will be benefit in some of these other trials—but it is no guarantee. Ongoing and additional research is needed to clarify the full potential of ARV-based prevention.

“This is an astonishing scientific achievement and a great boost to the microbicide field. At the same time, the results are complicated, and we will need to work hard to make sure that women and their partners understand what these results do and do not mean for the immediate future and in the long-term,” said Warren. “We are committed to working with communities to understand the results and the next steps.”

“The CAPRISA 004 results add immensely to the drive for a comprehensive response to HIV,” Warren added. “That means ensuring access for all who need it to existing HIV prevention and treatment options, including male and female condoms, behavior change counseling, male circumcision, clean needles, harm reduction and antiretroviral drugs; ensuring continued research to find effective new options, including microbicides, PrEP and vaccines; and planning for integrating these new interventions into combination programs.”

CAPRISA 004 was led by the Centre for the AIDS Programme of Research in South Africa (CAPRISA) at the University of KwaZulu-Natal and FHI and CONRAD in the US, and sponsored by the US Agency for International Development (USAID) and TIA, a biotechnology agency of the South African government’s Department of Science and Technology.

An AVAC report, A Cascade of Hope and Questions: Anticipating the results of upcoming ARV-based prevention trials and additional information about CAPRISA 004 and other upcoming results are available online at center;”>###
 

Press Release

AVAC Says MDP 301 Microbicide Trial Results Disappointing, But Researchers and 9,400 Trial Volunteers Deserve Praise for Successful Trial

Funding and Support for HIV Prevention Research Must Continue

Press Release

Shifting Scientific, Health Priorities and Global Economic Downturn Impact Investment in HIV Prevention R&D

Cape Town — A new report on investment in HIV prevention research in 2008 finds that HIV vaccine research funding levels decreased for the first time since investment trends have been tracked. This may have been influenced by shifts in scientific priorities, the declining economy and competing priorities in the larger global health agenda. Despite this decrease, the overall trend since 2000 has been of increasing investment for experimental biomedical prevention strategies.

The report, Adapting to Realities: Trends in HIV Prevention Research Funding 2000 to 2008, was released at the 5th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Cape Town South Africa by the HIV Vaccine and Microbicide Resource Tracking Working Group. It is available online at http://hivresourcetracking.org/.

The report identified investments of almost $1.2 billion in HIV prevention research in 2008, of which $868 million supported vaccine R&D, and $244 million supported microbicide R&D, while other HIV prevention R&D received much lower levels of funding. AIDS vaccine research declined for the first time since 2000, falling by ten percent from 2007 levels. At the same time, funding for both microbicides and preexposure prophylaxis (PrEP) increased by eight and 13 percent, respectively.

Funding for HIV prevention research remains a relatively small percentage of the overall response to HIV/AIDS. A recent report released by the Kaiser Family Foundation and UNAIDS documented commitments from the developed world for HIV/AIDS treatment and prevention programs in developing countries of $8.7 billion in 2008, up from $6.6 billion the previous year.

“Research to develop new HIV prevention tools and strategies is essential to prevent new infections, and an HIV vaccine still holds the greatest hope to ending the epidemic,” said Michel Sidib�, Executive Director of UNAIDS “It is vitally important that investments into research for HIV prevention be sustained and increased for as long as it takes to reach those goals.”

The Resource Tracking Working Group identified a critical need in this time of shifting budget priorities and economic uncertainty for the HIV prevention research field to identify funding needs and put in place scientific plans to help guide research decisions. These steps will ensure that there is no duplication of efforts and that funding can be linked efficiently to scientific priorities.

“Support and interest in HIV prevention research from public, private and philanthropic funders over the last decade has supported key R&D priorities, moved the field forward and brought us closer to new HIV prevention options,” said Mitchell Warren, executive director of AVAC. “We face tremendous challenges — both scientific and economic — over the coming years, but we must not lose the momentum we have gained. The field needs sustained support from a range of funders. The AIDS epidemic shows no signs of slowing, and the desperate need for new HIV prevention options will not change.”

Levels of funding in 2008 reflected key shifts in the HIV prevention research field. The halting in late 2007 of the Step and Phambili vaccine trials, which were testing a candidate vaccine developed by Merck, ended one of the only pharmaceutical company partnerships for HIV vaccine R&D. This slowing in industry involvement is reflected by a decline in industry funding levels in 2008. Pharmaceuticals and biotech companies in 2008 accounted for only four percent of HIV vaccine research funding. Levels were even lower across other HIV prevention research priorities. Nevertheless, the commercial sector contributes to the development of HIV prevention research in a number of ways through pharmaceutical company support. A number of companies have provided ARV compounds for development as potential microbicides, and as oral PrEP, along with technical support to microbicide product developers.

“The worldwide economic crisis has fueled debate about the best way to invest in global health, with some arguing that AIDS takes up resources at the expense of efforts to deal with other diseases and to improve health systems in the developing world. But given that AIDS is the number one killer in sub-Saharan Africa, and number four in the world, it is imperative that we reverse this pandemic, and that can only be done through improved methods of prevention, including a vaccine. If we can conquer AIDS, we will be able to invest resources in other pressing priorities,” said Seth Berkley, President and CEO of the International AIDS Vaccine Initiative.

It is important to note that HIV vaccine research and development is continuing to move forward. Just today, the South African AIDS Vaccine Initiative announced the start of a trial to study a vaccine candidate developed by local South African scientists. Results are also expected later this year from the largest vaccine trial ever, which successfully enrolled more than 16,000 participants. In addition, researchers around the world are developing new vaccine approaches and conducting basic research to inform vaccine development.

The report notes that increased investment in microbicide R&D may reflect increased interest in research on antiretroviral (ARV)-based candidates. Investment increased in microbicides overall at the same time that the field intensified its focus on ARV-based approaches to microbicide development.

“Increased funding for microbicide R&D over the past decade has fostered a major expansion for the field; clinical trials of microbicide candidates have been conducted in 27 countries around the world; and pre-clinical research has yielded important scientific information. Support from public, private and philanthropic funders is essential to increase R&D for new microbicide candidates,” said Polly Harrison, Director of the Alliance for Microbicide Development.

The U.S. government was once again the primary funder for HIV prevention research, supporting 71 percent of HIV vaccine R&D, 63 percent of microbicide R&D, and providing 46 percent of funding for PrEP prevention research in 2008. A decrease in investment from the U.S. National Institutes of Health contributed to the overall decline of funding for HIV vaccine R&D. The U.S. government investment fell by $39 million, a six percent decrease. Other governments also decreased funding for HIV vaccine research in 2008: European government funding fell by 13 percent and total funding from other countries (including Brazil, Canada, India, South Africa, and Thailand) fell by 16 percent.

The report authors caution that while it is too early to attribute all of the funding decreases to the financial crisis, there is concern that a prolonged global recession could have a major impact on public investment in all HIV/AIDS programs. A recent report from UNAIDS and the World Bank found that the economic crisis has already affected levels of funding for treatment and prevention programs in some developing countries.

The Working Group also reported on investment in operational research related to proven biomedical HIV prevention research interventions — medical male circumcision and ARVs for prevention of vertical transmission of HIV from mother to child. These efforts are being funded at much lower levels that other HIV prevention research, with $11 million supporting research related to rollout of male circumcision and $21 million supporting operations research for prevention of vertical transmission. 

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Press Release

Piecing Together the HIV Prevention Puzzle: AVAC Report Assesses Progress in AIDS Vaccine, Microbicide and PrEP Research and Calls for Urgent Coordination and Leadership in Advance of Upcoming Results

New York, NY — “It’s an exciting time in HIV prevention research. We will see results from a number of critically important HIV prevention research trials this year, as well as see the start of new trials around the world that will yield important answers in the years to come,” said Mitchell Warren, AVAC executive director, at the release of AVAC’s 13th annual report of the field.

“But scientific, community and political leaders must act now to plan for continued research and implementation of effective strategies, or this excitement will be wasted.”

The report — Piecing Together the HIV Prevention Puzzle — looks at AIDS vaccine research, where there is an energized focus on discovery, innovation and basic science and looks at the broader HIV prevention field, particularly the implications of pre-exposure prophylaxis (PrEP) and other strategies in efficacy trials today.

This analysis of the HIV prevention field comes in a year that has already brought disappointment as well as intriguing results from various prevention studies. At the same time, even trials that failed to show overall benefit, such as the Step Study of the Merck HIV vaccine candidate, have continued to generate new, valuable information and questions that would not otherwise exist.

These trials have succeeded as a result of increasingly robust partnerships between researchers and communities grappling with HIV, including gay men around the world and heterosexual women in Africa. These partnerships, along with the persistently high rates of new infections, are a continual reminder of the global commitment to and need for continuing the search for new prevention for as long as it takes.

“We hope to have new prevention intervention pieces to add to the puzzle in the next few years,” said Warren. “But as the slow implementation of male circumcision to reduce heterosexual men’s risk of HIV infection reminds us, we need extensive planning and guidance to ensure research results are translated into real impact against the epidemic. We can’t afford to wait for efficacy results before we begin to plan. We must anticipate and tackle the major hurdles for implementation now.”

The Report identifies major issues for implementation of new prevention options, including:
–    Ongoing global failures to scale up access to HIV testing and counseling services.
–    Persistent inattention to the needs of gay men and other men who have sex with men around the world.
–    Gaps in health care infrastructure that will complicate introduction of any new strategy.

In the Report, AVAC also underscores the importance of WHO and UNAIDS getting involved in planning for the results from PrEP trials before data are available.
“WHO and UNAIDS, along with other stakeholders, need to combine their strengths now to provide leadership and coordination so that the world is ready to work with results from the many ongoing PrEP trials,” said Warren.

Positive results from current vaccine, PrEP and microbicide trials will also present challenges and opportunities for other ongoing and planned HIV prevention trials.

“There has been concern that positive results from PrEP trials would require vaccine or microbicide trials to become larger, longer and more expensive, as PrEP could become a standard of prevention in these trials,” said Warren. “But we believe that success in one trial will open up possibilities and options for research that could combine AIDS vaccines and other interventions as they emerge.”

To help guide efforts in new areas of research and sustain ongoing research, AVAC calls for researchers and trial sponsors to begin planning on how combination strategies can be evaluated.

As the field looks to fit the puzzle pieces together, the AVAC Report also identifies a number of big questions in AIDS vaccine research for 2009 and beyond, focusing on issues such as cell-mediated viral control, HIV genetic diversity, the role of animal models, immune activation, antibodies and adjuvants.

In its analysis of the vaccine field, AVAC also assesses the progress and future potential of the Global HIV Vaccine Enterprise and considers the impact of results from the Thai prime-boost vaccine trial that are expected in September. With over 16,400 participants, this is the largest AIDS vaccine trial ever undertaken.

“In AIDS vaccine and HIV prevention research today, we see a fertile mix of big science and individual efforts, of product-oriented work and of slow and steady basic science,” Warren added.

“What we need now is a quick, strategic, scientific analysis of all the efforts underway, with a goal of identifying gaps and opportunities for synergy both within the AIDS vaccine field and across the vaccine, PrEP, and microbicide fields. AVAC is excited to help move the HIV prevention field toward a collaborative agenda and to prepare now for implementing potential new prevention options.”

Piecing Together the HIV Prevention Puzzle is available at http://www.avac.org/reports.htm. 

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Px Wire April-June 2008, Vol. 1, No. 2

PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research, implementation and advocacy. Highlights in this issue of PxWire include an update on the ongoing discussion regarding the proposed PAVE 100 vaccine trial, details on the first microbicide trial in pregnant women, a Mexico City preview, and notes on two recently released resources for the field, AVAC Report 2008: The Search Must Continue and the Global Campaign for Microbicides’ Microbicides Essentials online learning tool.

Px Wire Abril-Junio 2008, Vol. 1, No. 2 (en español)

PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research, implementation and advocacy. Highlights in this issue of PxWire include an update on the ongoing discussion regarding the proposed PAVE 100 vaccine trial, details on the first microbicide trial in pregnant women, a Mexico City preview, and notes on two recently released resources for the field, AVAC Report 2008: The Search Must Continue and the Global Campaign for Microbicides’ Microbicides Essentials online learning tool.

Px Wire January-March 2008, Vol. 1, No. 1

This is the first issue of our new quarterly, PxWire, which tracks key developments in the field of HIV prevention research, including the launch of new trials, results of ongoing studies and an up-to-date tally of trials going on worldwide. PxWire is designed to complement AVAC’s other publications and to help advocates stay on top of the ever-changing field of HIV prevention research. It is the first one-stop source for information on the full range of HIV prevention research going on worldwide, including vaccines, microbicides, pre-exposure prophylaxis (PrEP), herpes simplex virus-2 treatment, male circumcision, cervical barrier methods and partner treatment.

Press Release

AIDS Vaccine Advocacy Coalition Calls for Strategic Leadership and Urgency in the Implementation of Male Circumcision for HIV Prevention

New York, NY — Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC) today issued the following statement regarding the new recommendations from the World Health Organization (WHO) and UNAIDS on male circumcision as an HIV prevention strategy.  

“AVAC welcomes the new recommendations from WHO and UNAIDS on the range of policy, operational and ethical issues that will help guide countries about where and how male circumcision can be best implemented, promoted, and safely performed. These normative recommendations are essential to ensuring successful rollout of male circumcision to protect against HIV infection.

“Adding the offer of safe, sterile, voluntary male circumcision to existing HIV prevention programs could avert many infections and save many lives. These programs could also provide a new way to reach men and adolescent boys who are frequently under-represented in health clinics and HIV prevention programs.
 
“As important as the new recommendations are, though, they are only a first step in translating research findings into real public health impact. This international guidance document must now be complemented by funding, technical assistance and operational research at the country level to help national governments and health ministries develop and implement policies and programs to ensure that male circumcision is as part of a comprehensive package of prevention interventions.

“If these resources are not immediately forthcoming, there is a real risk that the benefits of male circumcision will be negated by complications relating to unsafe surgeries performed by unskilled practitioners seeking to profit from demand, which is likely to increase as news of these data spread through communities around the world.

“It is also absolutely critical to recognize the unanswered questions about male circumcision, including: whether it is safe for HIV-positive men and their partners; whether it provides any protective benefit to women who are sexual partners of circumcised, HIV-positive men; and whether it has any protective benefit in the context of anal sex.

“But not having all the answers should not stop us from making the first big steps of using the overall finding to help reduce new infections. Making and resourcing clear plans for filling in these gaps must be given equal priority to rollout based on what we know today.

“The benefits of male circumcision can only be realized if male circumcision is offered in programs that contain clear, cultural and context-specific messages and that explain the benefits and limitations of the procedure for men and their sexual partners and the importance of proper wound healing before resuming sexual activity.

“Policymakers will face complex decisions as they seek to implement these recommendations. Decisions about targeting high-risk men should be made with the utmost care, and it is also essential that circumcision not become falsely viewed as an indicator of HIV-negative serostatus. Programs must develop communications strategies and packages of services that counter this impression and meet the needs of HIV-negative men, HIV-positive men, and especially their partners.

“Research and dialogue are also needed now to explore the feasibility of rolling out infant circumcision. This approach will not show immediate benefits in terms of HIV incidence but can minimize risks and could be a highly cost-effective implementation strategy over the long term.”

AVAC’s report on understanding the results of the male circumcision trials as well as a detailed statement on research priorities for male circumcision and advocacy fact sheets for civil society in the US and in sub-Saharan Africa are available at www.aidsvaccineclearinghouse.org/MC.

About AVAC: Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a non-profit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of AIDS vaccines and other prevention options.

Press Release

AVAC Applauds Commencement of First HIV Vaccine Efficacy Trial in Africa

New York, New York — The AIDS Vaccine Advocacy Coalition (AVAC) heralds today’s launchof the first African efficacy trial of an experimental HIV vaccine as a critical, strategic and historically-significant step in the search for an AIDS vaccine.

The trial, which is known as Phambili (a Xhosa word meaning “moving forward”) or HVTN 503, was launched today in South Africa by the South African AIDS Vaccine Initiative (SAAVI) and the HIV Vaccine Trials Network (HVTN) of the US National Institutes of Health.

“South Africa and the partner agencies in this study are demonstrating tremendous leadership. With the stakes as high as they are in the epidemic, accelerating large-scale efficacy trials in the countries and communities that need an HIV vaccine the most is the kind of forward-looking, strategic decision-making that the field needs and should embrace,” said Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC).

The same vaccine candidate, which has been developed by Merck Research Laboratories, is currently being tested in another efficacy trial being conducted in various sites in North and South America, the Caribbean and Australia. The data from this study, known as the Step Study, are not yet known. Phambili has been initiated before the conclusion of the Step Study to help speed the progress of gathering additional important data in sub-Saharan Africa.

“The timing of the Phambili trial launch is a bold decision,” said Warren. “There is an urgent need to identify new AIDS prevention strategies as quickly as possible; this sequence of trials will help move the field forward as quickly as possible. These two trials will combine to shed light on whether this vaccine candidate has the potential to be a truly global vaccine that can eventually be used in both developed and developing countries.”

“As this trial moves forward, AVAC also hopes that this vaccine candidate will also be studied among adolescents. Adolescents are at great risk of HIV infection, and AVAC strongly supports the inclusion of adolescents in future trials so that we can get answers as quickly as possible for this priority population,” Warren said.

“Finding an effective AIDS vaccine will not happen in one isolated sector or country, but from international collaborations between industry, government agencies, academia, and publicprivate partnerships. Phambili is an excellent example of putting public funds to good use to test a promising vaccine candidate,” Warren said.

While there have been a significant number of small and mid-size safety studies conducted in sub-Saharan Africa, Phambili is the first study that is designed to provide information on whether or not a vaccine protects against HIV infection or helps to blunt HIV disease. Neither the Step study nor the Phambili trial has been designed as the final study of this vaccine candidate; if there are indications of efficacy, additional studies will be conducted to confirm this preliminary finding.

About AVAC: Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a nonprofit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of AIDS vaccines and other prevention options. For more information, visit www.avac.org.