According to statistics published by UNAIDS and the World Health Organization in November 2011, the global population of people living with HIV/AIDS in 2010—the most recent year for which such statistics are available—stood at 34 million.1 Yet in spite of the ongoing urgency to develop HIV/AIDS vaccines, various research groups and small biopharma companies around the globe are encountering challenges in raising the levels of funding that are necessary to sustain effective research and clinical trials.
For example, HIV researchers in India recently asked the country’s government to increase funding for their efforts. According to the Times of India, experts at an international symposium on HIV and infectious diseases in Chennai called funding levels “largely insufficient and disappointing” given the number of people suffering from the viral infection. 2 Meanwhile, The Gazette of the University of Western Ontario reported that the National Research Council of Canada recently awarded Sumagen Canada Inc. $728,000 for a Phase 1 human clinical trial for its HIV vaccine candidate; yet the lead researcher, Chil-Yong Kang, acknowledged that the complete trial is “going to take almost ten times that amount.”3
The difficulties being encountered by researchers and small biopharma companies engaged in HIV/AIDS vaccine research can be traced to a number of factors, but three stand out. First, the notion that the crisis has lessened since it first came to public prominence in the early 1980s; second, the view that the lack of a viable vaccine to date means that none is forthcoming; and third, the nature of financial support from the National Institutes of Health and potential investors. These beliefs will be examined in turn.
First, why has the crisis faded from the public consciousness, domestically and elsewhere, in spite of the continued high cost of existing treatment regimens?
Consider attitudes within the United States. There are segments of the American public who believe HIV is a nonissue based on the fact that antiretroviral therapy drugs can be effective and provide an extended lifespan to those living with HIV. What they fail to realize is that the current high cost and substantial side effects of these treatments are still problematic—not a long-term solution, and certainly not a solution for developing regions of the globe.
The residents of developed nations in 2012, and the governments they elect, may be tempted to believe the HIV/AIDS crisis is a problem for other parts of the world. In fact, every year in the United States there are 55,000 new HIV infections,4 a number that has remained unchanged since the mid-1990s despite the use of counseling, medications, and protective measures.
In this sense, government attitudes may be mirroring media coverage of HIV/AIDS, which, according to a recent study, fell more than 70% in developed countries over the last two decades. This study—the Trends in Sustainability Project, a joint project of the University of Leeds, Queen’s University Belfast, the Berlin-based Institute for Futures Studies and Technology Assessment (IZT), and Euromed Management School in Marseille—tracked coverage of a variety of sustainability issues in 115 leading broadsheet newspapers in 41 countries from 1990 until May 2010. Although it is true that newspaper readership has been steadily eroding over the past decade due to the rise of alternative online news sources, this study is still a clear indicator of the priority that traditional news organizations assign to various topics. In the early 1990s, an average of 1.5 articles about HIV/AIDS was found in every issue of these newspapers; since 2008, that average has fallen to less than 0.5.5
The second principal factor that may be contributing to government reticence for long-term HIV/AIDS research funding: the spotty record of vaccine efforts to date. It is true that over the last couple of decades, there have been many false hopes, and plenty of failures, on the road toward a resolution of the HIV crisis. As a result, it is tempting to doubt that a cure or treatment lies on the horizon. Yet, individuals in governments who hold this belief are not paying attention to the positive news from clinical studies that shed a very real ray of hope on finding a safe, cheap, universal treatment.
Tremendous progress is being made toward the development of an effective vaccine. In autumn 2009, a collaborative effort between the Ministry of Health in Thailand, the U.S. military, and the U.S. National Institute of Allergy and Infectious Disease (NIAID) announced the first encouraging results from an efficacy trial—31% prevention of infection in a 16,402 person community-based trial in Thailand.6 This result achieved significance in an analysis that excluded the seven subjects who were found to have been infected at the time of the first vaccination, demonstrating for the first time that an HIV vaccine can prevent infection.
Meanwhile, a research group at Emory University may be one step closer to finding a vaccine that will provide long-lasting protection against HIV/AIDS. Harriet L. Robinson, PhD, senior vice president for research and development at GeoVax Inc. working alongside her team at Emory University, showed that a novel class of vaccines against HIV/AIDS has demonstrated significant protection against the most potent strains of HIV infections in animal models.7
The novel class of vaccines is a combination vaccine in which the first component is a DNA vaccine co-expressing granulocyte-macrophage-colony stimulating factor (GM-CSF) and HIV virus-like particles that prime the immune response, and the second component is an attenuated vaccinia virus (MVA) also engineered to express HIV virus-like particles to boost that response. Using a vaccine candidate in monkey models, Robinson’s team has been able to demonstrate that this combination is capable of preventing infection during 12 rounds of infection in simians. Most notably, the GeoVax candidate has shown effectiveness against SIV251, the simian or primate version of the most virulent and hard-to-treat form of HIV in humans. Finally, the nature of National Institutes of Health (NIH) funding for biopharma companies—as well as the tendencies of investors—must be taken into account. The NIH is very supportive of new protocols and the running of clinical trials. However, during the long clinical trial period, a company must separately fund general overhead and vaccine production. Once a vaccine candidate exhibits human efficacy in later stage trials, equity investors and partnering opportunities are more prevalent. Meanwhile, finding equity investors is a challenge due to the long timescales involved in developing a viable vaccine; investors are more likely to seek out opportunities that pay off in a relatively shorter term.
As previously noted, there is more than one factor driving the challenges currently facing small biopharma companies engaged in HIV/AIDS vaccine work. Better recognition of these and other factors will lead to a more realistic level of funding for a disease that still threatens millions worldwide.
1. “Global HIV and AIDS estimates, 2009 and 2010.” AVERT. Available at: https://www.avert.org/worldstats.htm. Accessed on Feb. 23, 2011.
2. “Experts ask Centre to increase funding for HIV/AIDS research.” The Times of India, Jan. 22, 2012. Available at: https://articles.timesofindia.indiatimes.com/2012-01-22/chennai/30652579_1_international-aids-vaccine-initiative-aids-research-institute-vaccine-candidates. Accessed on Feb. 22, 2012.
3. Carmona A. “HIV vaccine research gets funding boost from federal government.” The Gazette. Janurary 20, 2012. Available at: https://www.westerngazette.ca/2012/01/20/hiv-vaccine-research-gets-funding-boost-from-federal-government/. Accessed on Feb. 22, 2012.
4. “HIV/AIDS Prevention Today.” National Prevention Information Network. Available at: https://www.cdcnpin.org/scripts/hiv/prevent.asp. Accessed on: Feb. 23, 2012.
5. Mazzotta M. “Where has all the AIDS news coverage gone?” Science Speaks: HIV & TB News. Available at: https://sciencespeaksblog.org/2011/01/04/where-has-all-the-aids-news-coverage-gone/. Accessed on Feb. 22, 2012.
6. Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, et al. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med. 2009 Dec 3;361(23):2209-2220.
7. Robinson H. Long-term protection by a GM-CSF co-expressing DNA/MVA vaccine in the SIV/macaque model. Poster to be presented at 19th Conference on Retroviruses and Opportunistic Infections (Seattle, March 5-8, 2012).
Filed Under: Drug Discovery