The global scale of the AIDS epidemic prompted Dr. Anne De Groot, HIV physician, Brown University AIDS Vaccine researcher and Biotech entrepreneur to use computer-based tools to search HIV databases for AIDS "Achilles' heel". On May 1, De Groot was awarded a $2.7 million vaccine grant from the NIH to support further development of her vaccine. This award provides much needed funding for in vitro studies of human response to "cross-clade" epitopes - the "Achilles' Heel" of the AIDS virus.

One of the greatest barriers to developing an effective HIV-1 vaccine is the diversity of HIV-1 viral strains and clades, due to the very high mutation rate of the HIV virus. Different types of HIV exist in every region of the world that has been affected by the epidemic. The most effective type of vaccine in the global context of the HIV epidemic would therefore include immunogenic regions, or epitopes, of the HIV-1 genome that are highly conserved across clades and strains of HIV-1, the so called "Achilles' heel' of HIV because these regions represent parts of the virus that it needs to function, and is therefore not able to mutate away from immune response.

De Groot invented the concept and named her vaccine the "GAIA Vaccine" about one year ago, which co-incided with the founding of a non-profit organization, the GAIA Vaccine Foundation, to help support the effort. Using powerful new bioinformatics tools developed at her TB/HIV Research Lab at Brown, De Groot and her colleagues at the Lab and at EpiVax, the company that has now licensed and refined the tools, have selected epitopes (virus protein sequences that turn on the human immune system) that are conserved (the same or very similar) across many different strains (clades) of HIV. These bioinformatics tools also enable De Groot to choose epitopes that are promiscuous (will work for genetically diverse human immune systems). The lab at Brown is engineering the epitopes into a delivery vehicle that will be stable under clinical conditions in the developing world and affordable for countries that are most in need of the AIDS vaccine.

The GAIA vaccine is expected to take four to five years and will require $6M (an additional $3.3M) in funding before it is ready for Phase I trials. Due to her concern about establishing a continuous source of funding for the project, Dr. De Groot decided to establish the GAIA Vaccine Foundation on May 18, 2001. The mission of the GAIA Vaccine Foundation is to provide bridge funding from private donors and foundations for the GAIA Vaccine and for other research groups that are working on developing "globally relevant, globally accessible" HIV vaccines.

In order to confirm that the GAIA vaccine is relevant to individuals living in those parts of the world that are worst affected by HIV/AIDS, in vitro (laboratory based) screening are planned in collaboration with Malian investigators, in Bamako, Mali. GAIA Vaccine Foundation has applied for funding to support the development of the GAIA vaccine in partnership with researchers in developing countries. In another departure from the standard approach to vaccines, De Groot has designated the GAIA vaccine to be a "not for profit" collaboration between EpiVax, the TB/HIV Research Lab, and GAIA Vaccine foundation. The vaccine would be licensed and distributed to developing countries at no cost or very minimal cost.

De Groot is assistant professor of Medicine at Brown University and Director of the TB/HIV Research Lab, where she and her associates are constructing epitope-driven vaccines for TB, HIV, HPV (human papilloma virus) and HCV (hepatitis C virus). She is also recipient of a $900,000 award from the Sequella Global Tuberculosis (TB) Foundation for a TB Genome-derived TB vaccine. That vaccine is expected to enter Phase I trials next year. De Groot teaches a graduate level course on vaccines at Brown and has also served as the "honors thesis" mentor for a number of undergraduates who have gone on to develop careers in biomedical research.

The rationale for developing the multi-epitope cross-clade GAIA vaccine is straightforward. In studies performed by other researchers (Bruce Walker, Sarah Rowland Jones), HIV-infected individuals with immune systems that respond to many different HIV epitopes are able to contain their HIV infection, when compared to individuals who don't respond to many epitopes. Most researchers now believe that the best candidate for an AIDS vaccine will be one that simulates this type of broad immune response that is seen in "long term survivors" of HIV infection. Therefore, the GAIA vaccine will contain many different HIV epitopes, derived from all of the HIV proteins, which will provide protection against a broad array of diverse HIV viruses. In pilot studies performed at the TB/HIV Research Lab, Brown University, the laboratory that developed the GAIA vaccine concept, 43 broadly conserved or cross-clade HIV epitopes have been confirmed in ELIspot assays. These assays proved that the epitopes elicited an immune response from healthy HIV infected subjects, and perhaps more important, that the epitopes selected by the Lab's computer programs were indeed processed and presented in the course of a natural HIV infection.

GAIA Vaccine Foundation board member Bill Twadell, former ambassador to Nigeria, has said "HIV/AIDS has been a catastrophe for individuals and societies everywhere but none have been more affected than Africa's. There, many countries and cultures are under great stress that will only increase until the pandemic abates. Adults in the years of their greatest productivity are primary sufferers and the potential of their minds and muscle is reduced or lost to a continent that desperately needs all their energy. Also, that essential generational link that imparts direction and example is at risk, with predictable dangerous social consequences. HIV/AIDS needs to be attacked at all points of possible intervention: education of those without the disease and treatment for those with it. Most important is the urgent need for research and development of a universal vaccine that will contain and ultimately eliminate the scourge."

Robert Morris, a Newport RI entrepreneur, has said "the globally present danger posed by the AIDS epidemic becoming the modern day equivalent of the Black Plague, is easily overshadowed. For this reason I believe the goal of GAIA is well worthy of our attention."

More information on GAIA can be found at http:/www.GAIAVaccine.org