News

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.

Mitchell Warren, the executive director of AVAC and a founding member of GHTC, wrote the following op-ed in reaction to Secretary of State Hillary Clinton’s speech at the National Institutes of Health and her announcement to prioritize achieving an AIDS-free generation. This op-ed originally appeared in The Hill’s “Congress Blog” this week. Last week at the National Institutes of Health (NIH), Secretary of State Hillary Clinton laid out an ambitious vision to end the HIV and AIDS pandemic. In a statement that no US leader has made before, Clinton said that it is possible to achieve an AIDS-free generation. The goal Secretary Clinton lays out is indeed possible, and we welcome her announcement of an additional $60 million for implementation of a combination of prevention strategies in four sub-Saharan African countries and evaluation of their impact. But this funding can only be viewed as a down payment on the work that needs to be done. In order to get there, the Obama administration, along with developed and developing country governments around the world, need to add specific commitments, milestones, and strategies to the vision. And they need to commit to the long haul. It is 16 days to World AIDS Day, and we expect to hear additional commitments and see leadership from President Obama, with an eye to both the international and domestic epidemics. The good news is that, as Secretary Clinton emphasized, there is a strong foundation on which to build. Thanks in large part to prior US support for HIV research and implementation, particularly via the NIH, we have today three key tools to help end the epidemic: voluntary medical male circumcision, effective treatment for people living with HIV, and prevention of mother-to-child transmission. If taken to scale, the number of new infections will plummet. But Secretary Clinton also noted the need to continue developing new tools for tomorrow. The commitment to both research and implementation must be unwavering. There are three critical research priorities that require long-term investment to truly close the door on AIDS. First, we need real-world research to understand how best to use additional HIV prevention tools that were recently found effective in clinical trials, including topical microbicides and pre-exposure prophylaxis, or PrEP. Second, we need to sustain the search for a vaccine to prevent HIV, especially now that the vaccine field is being re-energized by promising new scientific advances. Third, we need to pursue the increasingly real possibility of developing a functional cure for HIV infection. It is critical to sustain investments in research and development for additional powerful prevention tools. On World AIDS Day, we will be listening for a strong, specific commitment to scaling up the tools we have at our disposal immediately, with a focus on combination prevention and an emphasis on HIV testing and counseling, which is the gateway to male circumcision, prevention of mother-to-child transmission, and treatment and care for HIV positive people. Now is the best possible moment to invest in research, when the possibilities for long-term success are greater than ever before. This is when we should double down on some of the amazing successes we’ve seen in the past few years. As Secretary Clinton said in her speech, it is possible to create an AIDS-free generation. Research has made this goal possible, and we must stay focused on the future. We cannot turn back now. Not when there is a potential end to this epidemic finally in sight.

Heather Ignatius is the senior policy manager for the TB Alliance, a not-for-profit, product development partnership dedicated to discovering, developing, and ensuring access to better, faster-acting, and affordable drugs to fight tuberculosis (TB) and drug-resistant TB. She is also a member of the GHTC’s Steering Committee. The most recent WHO TB Control report noted that rates of TB declined this past year for the first time in decades. However, even with such progress, TB remains one of the most devastating global health crises today, with ripple effects that extend beyond health to cripple prosperity and development of regions overwhelmed by the disease. New and improved tools to prevent, diagnose, and treat TB in its many forms—including MDR-TB and XDR-TB—are vital to eradicate the disease, but a reinvention of such an arsenal can’t be achieved by any single organization. To this end, last week marked another notable achievement for TB: the launch of a collaboration between four pharmaceutical companies, along with the TB Alliance and the World Health Organization (WHO), which enables information-sharing on TB drug candidates within their respective pipelines. The partnership aims to bring these groups together to quickly and collaboratively identify and develop the most promising new TB drug regimens, regardless of sponsor. Representatives from (left to right) TB Alliance, Tibotec, Sanofi, Bayer, Sequella, and AstraZeneca gather at the CPTR Workshop to discuss new approaches to TB drug R&D. The collaboration was brokered under the Critical Path to TB Drug Regimens (CPTR), a cross-sector initiative designed to speed the introduction of shorter, safer, and more effective new TB drug regimens. The partners include AstraZeneca, Bayer, Sanofi, Tibotec, the TB Alliance, and the WHO. Combinations of drugs are required to treat TB to avoid the development of resistance. Since the launch of CPTR in March 2010, regimen development—testing and seeking the approval of combinations of new TB drugs as opposed to developing individual drugs, one at a time—is emerging as the gold standard within the field. Regimen development can telescope the time it takes to develop novel drug combinations, which show promise to shorten, simplify, and create safer and more affordable treatment. In the context of appropriate drug-sensitivity testing, novel regimens can treat both TB and MDR-TB, and truly transform the tools to fight the epidemic. CPTR and this agreement establish mechanisms for cross-sponsor information-sharing and begin to chart the course for cross-company collaborations on new TB drug regimens. Those who signed onto the agreement represent the majority of global sponsors with TB drugs in clinical development. Earlier this year, the combination of PA-824 (a novel chemical entity), moxifloxacin (an existing antibiotic not yet approved for treating TB), and pyrazinamide (an existing TB drug) completed a Phase II clinical trial. Meeting this milestones further confirmed both its potential as a regimen and the co-development approach to TB drug development. With this “proof of concept” trial completed, the door is now open to bring forward additional multi-drug combinations. Progress to develop novel drug regimens also requires advances in regulatory science to enable regulators to support and evaluate clinical trials that use this paradigm. This theme was echoed at the CPTR Workshop where this announcement was made, which featured a keynote address from the Director of the Center for Drug Evaluation and Research at the US Food and Drug Administration (FDA), Dr. Janet Woodcock. “I congratulate all of you coming together to solve what was previously perceived as an intractable problem,” said Dr. Woodcock. “Working together, we can take the steps needed to control this disease worldwide. We at the FDA, we will do everything we can do ensure that the regulatory process is not a barrier to getting this problem solved.” It is uplifting to see such a collaborative approach being to TB drug development adopted by its stakeholders, including the pharmaceutical industry. While harnessing the resources necessary to conduct future regimen trials remains a challenge, there is justifiable optimism surrounding the scope and pace of TB drug development, and in turn, the impact that the introduction of new and improved TB therapies can have on the health and prosperity of millions.

After Secretary of State Hillary Clinton’s speech at the NIH earlier this week, GHTC asked our member organizations involved in HIV and AIDS why the US should continue to prioritize HIV and AIDS research. Here are answers from three of our members working on this issue: Elizabeth Glaser Pediatric AIDS Foundation: GHTC members stress the importance of prioritizing HIV and AIDS research in order to save lives around the world. Photo: Wendy Stone/PATH Discovering the medical interventions to prevent mother-to-child transmission of HIV (PMTCT) is one of the great success stories in the thirty-year fight against HIV and AIDS. But we cannot finish the job of eliminating pediatric AIDS worldwide without continued research. To implement the science that we do know, operations research is needed to address the global gaps in PMTCT coverage. Further clinical research is also needed to understand why approximately 60% of babies who are exposed to HIV from their mothers and receive no medical interventions still do not become infected. Answering this question could help in the development of an HIV vaccine that is safe and effective for children and adults, and provide lifetime immunity to the virus. International AIDS Vaccine Initiative: US support of HIV and AIDS research, including new HIV prevention tools, is vital to bringing an end to a pandemic that has taken and affected millions of lives in the US and worldwide, as well as cost the global economy billions of dollars. These investments also keep the US on the frontier of scientific innovation, as the lessons learned in trying to stop one most formidable foes ever encountered by scientists hold potential across many areas of medicine. Global Campaign for Microbicides/PATH: The generosity of the American people invested in HIV research can not only help to save the lives of poor people in other countries most greatly affected by HIV—but that same generosity can benefit the American people whose lives can also be saved by the same innovations. The world is a small place. As good global neighbors, prioritizing HIV research can help save the lives of poor people in not-so-distant lands. The same innovations in HIV treatment and prevention can save the lives of our neighbors much closer to home.