News

In a recent guest post for the ONE blog, GHTC director Kaitlin Christenson highlighted four game-changing HIV and AIDS interventions under development and the leadership from the US government that has helped foster these critical research breakthroughs. The fight against HIV and AIDS is not over, and a concerted effort must be made to prioritize research to develop new tools Photo: Robin Biellik/PATH The past three years have been historic in the number of breakthroughs in research to prevent, diagnose, and treat HIV and AIDS. For the first time, researchers proved that an HIV vaccine could prevent infection; an HIV prevention gel called a microbicide was shown to prevent infection among women; studies showed that a once-daily pill could reduce the risk of infection in high-risk individuals; and antiretroviral treatment among HIV-positive individuals was proven to reduce the risk of infecting their partners. "The fight against HIV and AIDS is not over, and a concerted effort must be made to prioritize research to develop new tools." Photo: Robin Biellik/PATHIt’s been incredible to see such progress over the past three years. But to be clear: these breakthroughs are a result of a long-standing commitment by international donors to boost research for HIV and AIDS. Innovations like these come as a result of years of work conducted by a variety of players—the private sector, NGOs, academic institutions and product development partnerships. In many cases, they are a direct result of the support provided by the US government. This commitment to research will continue to result in tools that change the way we approach the epidemic. Some impressive work is currently underway and promises to yield new interventions: Microbicides. Last year, a clinical trial in South Africa provided the first-ever proof that a vaginal microbicide could safely and effectively reduce the risk of HIV transmission to women. The trial was supported by the US Agency for International Development and two GHTC members, FHI360 and CONRAD. It provided new hope that an HIV-prevention tool designed for women could work. Additional research is needed on this product, though, and over the next two years, a follow-on trial will seek to confirm these results. Treatment as prevention. This summer, research supported by NIH demonstrated an astounding 96 percent reduction in transmission of HIV to an uninfected partner when his or her HIV-infected partner begins an antiretroviral regimen. Some questions remain about how this intervention might be implemented, and additional research is needed to understand how treatment as prevention will be operationalized. Oral pre-exposure prophylaxis (PrEP). Recent studies funded by the US National Institutes of Health (NIH) and others have confirmed that a daily dose of oral antiretrovirals can reduce the threat of HIV infection in high-risk groups. While additional research is needed to understand the implications of PrEP, many government agencies are considering adapting their HIV prevention guidelines to account for this new intervention. HIV vaccines. Two years ago, a clinical trial conducted in Thailand and funded by the US Department of Defense provided the first demonstration that a vaccine can prevent HIV infection in humans. While the results from this trial were too modest to support licensing this particular vaccine, trial data will help to inform the development of what researchers hope will be a more effective vaccine. On a recent trip to Kenya, my colleagues and I had the opportunity to meet with some of the research heroes who are leading the way in studying these and other interventions. The excitement they felt about the promise these new tools might provide was palpable. Lisa Mills, an American based with the CDC in Kenya, co-led a clinical trial which provided evidence for treatment as prevention. She told us that this intervention will have a “huge impact on communities. It will make HIV-positive people in these communities non-contagious. It’s also more cost-effective to do treatment as prevention, since you’re only treating HIV-positive people.” In speaking about research for microbicides, another of the individuals we met, Elizabeth Bukusi, deputy director at the Kenya Medical Research Institute (KEMRI), told us, “I think this is one of the tools that gives us the opportunity that we could actually end the epidemic. I think we can move towards a complete AIDS-free generation that will completely stop the epidemic in its track using microbicides as part of the armament.” She added that the “US has been a critical partner in providing catalystic funds and also in funding a large number of the trials that have looked at microbicides. So US funding is absolutely critical to moving this agenda forward.” Today, it is in our hands to decide the fate of future generations. The fight against HIV and AIDS is not over, and a concerted effort must be made to prioritize research to develop new tools — both those that are within arm’s reach, and those which still require much more study. Research is a long-term investment, and we must not give up on the commitments which have taken us this far. The US government is a leading supporter for research that has yielded many of the innovations we have today, and this support must not waiver even in the midst of today’s constrained budget environment. Will our leaders continue to set the stage? Imagine the breakthroughs that would be possible if so.

Tiffany Moy is the Global Health Research & Development Advocacy Intern at Research!America (R!A). R!A is the nation's largest not-for-profit public education and advocacy alliance committed to making research to improve health a higher national priority. R!A, in partnership with Aeras, the International AIDS Vaccine Initiative, the International Partnership for Microbicides and OneWorld Health, hosted a Capitol Hill briefing Nov. 15 on the role of product development partnerships (PDPs) in global health R&D. The event was co-sponsored by Reps. Brian Bilbray (R-CA) and Chris Van Hollen (D-MD). During the event, Bilbray acknowledged that the health challenges ahead of us will require sustained investment in the R&D process from both the public and private sectors, and he called for bipartisan support for both funding streams. “We can’t spend time patting ourselves on the backs,” Bilbray said. “[While we can’t] forget to celebrate our successes, we must continue to look at the challenges.” He declared the public and private collaborative network essential, saying without the basic research—or what he called the “sea plankton”—there would be no venture capital or opportunity to invest in the “krill.” Rep. Brian Bilbray (R-CA) speaks at Research!America's event on product development partnerships at the Rayburn House Office Building in Washington, DC, on Tuesday. “We must create the opportunity for people to invest their funds,” he said, “not just for the next iPhone for but the next breakthrough cancer treatment. Otherwise we just have good intentions without good solutions.” Mary Woolley, president and CEO of Research!America, moderated the discussion between panelists Ann Ginsberg, MD, PhD, vice president of Scientific Affairs at Aeras; Brid Devlin, PhD, executive vice president of Product Development at the International Partnership for Microbicides (IPM); Eugenio de Hostos, PhD, MBA, director of Research and Pre-Clinical Development at OneWorld Health; and Steve Fling, PhD, site director of the International AIDS Vaccine Initiative (IAVI) Neutralizing Antibodies Center at The Scripps Research Institute. Woolley’s opening remarks emphasized the role of health research as a major driver of the American economy and a key factor in our country’s global leadership. The panelists discussed how the non-profit PDP model speeds medical progress on diseases like HIV and AIDS, tuberculosis (TB), malaria and diarrheal diseases. PDPs play a vital role in accelerating the research and development of critical health technologies like vaccines, drugs, and diagnostics. The model allows risk sharing but also the sharing of technical resources and scientific expertise. Fling expressed pride in IAVI’s breakthroughs in the field of HIV and AIDS, as well as in its partnership with Seattle-based biotech Theraclone, which has led to additional partnerships with Pfizer and other drug companies. Devlin noted that IPM’s microbicide ring, designed to give women greater control over protecting themselves from HIV, is the first such product to come so far in the R&D pipeline. “HIV is the leading cause of death for women ages 15 to 44 worldwide,” she noted. The ring will enter late-stage clinical trials in early 2012. OneWorld’s de Hostos added that “this is not just about bringing technologies to bear on these diseases but it’s also about capturing the intellectual capital we have here.” Of solving one of the world’s greatest health challenges through the PDP model, Ginsberg said, “Using business practices, we are combining the public health need and expertise wherever we can find it. Ten years ago, there were no candidates and now there are 12 TB vaccine candidates in the R&D pipeline. [This is] the first time in history that so many TB vaccines have gotten so far” in the development process. A new, more effective TB vaccine could reach the market as early as 2020 and has the potential to greatly reduce the 1.4 million lives lost to TB each year. “This,” Ginsberg said, “could not have happened without the PDP model.” To learn more about how global health R&D is impacting the health and economies of other states, click here.

John Donnelly is a writer who accompanied the GHTC on its recent trip to Kenya. One of the most overlooked benefits of US-funded global health research is the training provided to scientists to do the work in their own communities.During the GHTC’s trip to Kenya last month, this type of capacity building was evident in several stops. One was from conversations with scientific investigators who have been researching the RTS,S malaria vaccine candidate. The first Phase 3 efficacy results of RTS,S—which is a public–private venture between the PATH Malaria Vaccine Initiative (MVI) and the pharmaceutical company GlaxoSmithKline (GSK), supported by funding from the Bill & Melinda Gates Foundation—found that it reduces the risk of clinical and severe malaria by roughly half in African children ages five to 17 months over a 12 month period.At one of the 11 trial sites, the Kombewa Clinical Trial Centre in western Kenya, the research has helped build a large staff of Kenyan researchers, doctors, nurses, and field workers. The Mal 55 trial, which was the main RTS,S research project at Kombewa, employed 124 Kenyans and just a handful of Americans.“Americans should know that we are not just giving people fish—we are teaching them how to fish,” said Dr. Louis Macareo of the US Army Medical Research Unit-Kenya and director of the Kombewa trial centre. “The biggest thing we are leaving behind is intellectual capital. They are becoming some of the best researchers in the world, even better than people in our own organization because of the volume of the work in the trials that they are involved in.”One of the most overlooked benefits of US-funded global health research is the training provided to scientists to do the work in their own communities.The research also provided the opportunity for many of the scientists to access education and training. In one case, physician investigator Dr. Lucas Otieno received his master’s degree in public health at the London School of Hygiene and Tropical Medicine partially due to support from the project. In return, Dr. Otieno agreed to stay for several years on the project.The RTS,S trial was just one example of capacity building. Dr. Pauline Mwinzi, a Kenyan, is the principal research officer at the neglected tropical diseases branch at the KEMRI-CDC office in Kisumu. The Kenya Medical Research Institute (KEMRI) and the US Centers for Disease Control and Prevention (CDC) have been partnering together in Kenya for more than 30 years. She said US training made all the difference for her.“We have benefitted from US government funding in terms of capacity building,” she said. “I was trained through the CDC. I wouldn’t be here without the CDC training that allows me to design these experiments that we are conducting at the moment and it’s not just me, but my entire department, my colleagues, and the funding that continues to come from the US government through the CDC” and the US Agency for International Development (USAID).Mwinzi added: “Without the US funding, we wouldn’t have moved much. We wouldn’t be able to move the sophisticated research that we do now.”Lynn Adrian, USAID’s health team leader in Kenya, told us that the training of Kenyan staff was one of those little-told stories that will have impact for years to come.“If I look at my own office, to start, in Nairobi, I have 38 staff and just three are Americans. The rest are Kenyans with incredible educational backgrounds and who very, very dedicated, very able to be able to influence policy and oversee programs,” she said. “This is not just true of the people in our office but as I go to the Ministry of Health I am also surrounded by technical experts who deliver leadership in fields like tuberculosis, in fields like malaria, maternal child health.”Adrian said the results of these trainings are being seen now, but will be even greater in just a few years.“For me as an American, as a taxpayer, and as a mom, these are the kinds of investments that we want to be making to be able to see out in five years or 10 years and see that the kinds of capacity building means institution strengthening going on all over this country,” she said. “It really will have a long-lasting effect.”

Jamie Rosen is the media & communications manager for Aeras, a GHTC member. Aeras and the TuBerculosis Vaccine Initiative (TBVI) recently hosted a booth at the Union World Conference on Lung Health to hear from conference attendees about the need for a new TB vaccine. This blog post reflects what Aeras heard and experienced at the conference. “TB vaccines, urgently needed. For how long should we be patient!” Nigerian Egbagbe Eruke’s eloquent words were echoed through the halls of the Lille Grand Palais. Physicians, academicians, and members of civil society and the private sector from over 100 countries gathered in Lille, France from Oct. 26-30 to discuss challenges in controlling tuberculosis (TB) and other lung health issues at the 42nd World Conference on Lung Health, hosted by the International Union Against Tuberculosis and Lung Disease. Conference participants were not shy in their calls for new vaccines to fight the world’s second deadliest infectious disease. “In TB, we are stuck with a 90-year-old vaccine that has limited efficiency! We need to move on!” appealed Lucica Ditiu, executive secretary of the Stop TB Partnership. “It’s time to think that we are all in the same boat of humanity,” added patient advocate Alberto Colorado, who lives along the US/Mexico border. Dr. Milton Chemhuren of Zimbabwe had this to say: “Prevention is the best, so I support the introduction of new vaccines. We can save a lot of lives and resources. Today our health services systems are overwhelmed by TB patients, especially with the HIV which has fueled TB in our countries.” This resounding support was captured on a world map at the exhibit booth shared by Aeras and the TuBerculosis Vaccine Initiative (TBVI). By the end of the conference, the map was covered with demands for new vaccines against TB. A slideshow was made to showcase the other messages. Modeling studies have shown that without new tools to fight TB, including vaccines, we will not come close to meeting the international goal to eliminate TB by 2050. Fortunately, after decades of research neglect, the past 10 years have welcomed dramatic progress in TB vaccine development, with 12 vaccine candidates currently in clinical trials. While scientific challenges remain—for example, there is no shortcut that accurately predicts immunity by looking at animal models or immune responses when the vaccine is given to people—progress has been substantial. These challenges help to explain the long timelines of TB vaccine development. Researchers estimate that we could have a new TB vaccine by 2020, assuming there is sufficient financial support and at least one of the current candidates meets efficacy requirements. Developing new vaccines against TB requires giving candidate vaccines to thousands of people in areas where TB is highly endemic—and then waiting to see how many get sick with TB in the vaccine group versus the control group. Before beginning these large-scale efficacy trials, each vaccine candidate must also be evaluated for safety in smaller trials in multiple populations. Right now, the most advanced TB vaccines under development are in Phase IIb clinical trials, sponsored by Aeras. In addition to co-hosting an exhibit booth, Aeras co-organized two sessions at this year’s Union Conference, “Partnerships to Accelerate TB Vaccine Development” and “Synergies in the Development of New Diagnostics, Drugs and Vaccines for Tuberculosis.” Two of the presentations from the first session are currently available as webcasts online, one by Aeras’ Chief Scientific Officer Tom Evans on “New Tuberculosis Vaccines in Clinical Development” and one by Videlis Nduba, Primary Investigator at the Kenya Medical Research Institute/US Centers for Disease Control and Prevention (KEMRI/CDC), on “Ensuring Site Capacity for Large-Scale and Multicentre Vaccine Trials.” Perhaps the highlight of the conference for many of us involved in TB vaccine development was a reception at the Institut Pasteur de Lille co-hosted by Aeras, Institut Pasteur de Lille, TBVI and the Stop TB Partnership Working Group on New Vaccines. After the formal reception, attendees had the surprise opportunity to tour the museum at the Institut Pasteur de Lille, which in addition to chronicling the life and work of Louis Pasteur also details the work of Albert Calmette and Camille Guérin in co-discovering the BCG vaccine. To make BCG, Calmette and Guérin passed bovine TB bacteria over potatoes from 1908 to 1921 to weaken its infectious properties and then gave it to a newborn infant in Paris, in whom it was effective in protecting against TB disease. Of particular interest were some of the original potatoes that these bacteria were passed over, as well as a model of an experiment using BCG to protect cows against bovine TB. BCG was given to 11 cows, then 12 were exposed to bovine TB. The dead cow on the left is the “control group” for this experiment, the only cow who did not receive BCG. Sylvain Guérin, the great grandson of Camille Guérin, expressed his support for modern TB vaccine research. “Camille Guérin has devoted his life to this fight and has tried to contribute with the BCG, and I would like to continue in order to perpetuate the family tradition,” he wrote on the exhibit booth map. While BCG has not been effective in preventing adult pulmonary TB, the most common and infectious form of the disease, it remains the most widely used vaccine in the world and has saved the lives of countless children who may otherwise have developed severe forms of disseminated TB. But with advances in modern science, we know we can do better, and with repeated pleas from conference-goers and others, we know we must. Aeras and its partners will continue to heed these calls until the world has new TB vaccines that are safe and effective for people of all ages, including people living with HIV, and are affordable and available to all who need them throughout the world.