Drs. Robert Gallo and Luc Montagnier to co-direct labs in U.S. & Rome

BALTIMORE, MD - On the heels of international news reporting AIDS the deadliest disease ever, Dr. Robert Gallo, who heads the Institute of Human Virology (IHV) in Baltimore, Md., and Dr. Luc Montagnier, President of the World Foundation for AIDS Research and Prevention, announced today their partnership in a global research endeavor designed to speed the discovery of AIDS vaccines - believed by scientists to be our greatest hope in halting the HIV/AIDS epidemic worldwide.

Created under the World Foundation for AIDS Research and Prevention working under the auspices of UNESCO, the Program for International Viral Collaboration will be co-directed by the two pioneering scientists, both universally recognized for their contributions to AIDS research over the last two decades.

Although AIDS was an unknown disease until 1981, this joint announcement comes as the severity of the epidemic reaches dramatic new proportions. Just last month, scientific journals and world news published reports that AIDS is the greatest epidemic and the deadliest disease in medical history, now surpassing the bubonic plague of the 14th Century.

"The Black Death came suddenly and then almost as suddenly disappeared," says Dr. Gallo, who with Dr. Montagnier, co-discovered the HIV virus in the 80s. "HIV/AIDS is worse. It is a chronic disease with no known cure and, like the common flu, continues to present new strains, making it difficult to treat, prevent, understand or anticipate. It is critical, as evidenced by the fact that some 25 million people worldwide have died of AIDS (three million in 2001) and another 40 million are believed to be infected with the HIV virus, that our attention and resources must be directed toward HIV/AIDS prevention."

Dr. Montagnier echos this sentiment. "HIV/AIDS is presently the greatest of threats to mankind and, unlike the Plague, it will not go away. This will occur only when medical science develops a treatment accessible to all and a successful vaccine to prevent infection."

Under the collaborative agreement, the Program for International Viral Collaboration is the platform for this joint research endeavor. The Foundation will provide leadership in developing resources to sponsor and fund an international research network involving research laboratories in Baltimore, Rome, Montreal, Nigeria, Cameroon, the Ivory Coast and other sites in Africa, Central America and Asia - all sites of high HIV prevalence where Drs. Gallo and Montagnier have longstanding research relations.

Research will be augmented by cohort studies as well as clinical trials. By targeting sites in Africa and other continents, the Program for International Viral Collaboration will provide the

optimal platform for a balanced international partnership and a comprehensive research program that will translate scientific concepts into practical and effective vaccines.

Two immediate opportunities utilize concepts developed at the IHV, one of the world's premiere research institutes whose work has revolutionized the field.

The vaccine unit, for example, has pioneered a novel oral vaccine delivery system utilizing Salmonella bacteria to more economically deliver a greater number of viral genes in order to stimulate an immune response in humans. The Salmonella delivery system is effective at enabling an immune response against sexual exposure to HIV.

The second vaccine targets tat, a molecule that the HIV virus uses to paralyze the immune system's response to the virus. The tat toxoid vaccine is based on research concepts developed by Dr. Daniel Zagury in Paris in collaboration with Dr. Gallo and has been developed by Aventis Pasteur, a European vaccine company and component of Aventis.

And, in another approach, IHV scientists have developed a novel vaccine that generates the broadest HIV immune response seen to date, blocking infection by diverse strains of HIV in laboratory experiments. Being developed at the IHV, the vaccine is expected to go into clinical trials in about two years.

Dr. Montagnier and his collaborators in Rome and Abidjan (Ivory Coast) are selecting HIV peptides from gag, tat, nef proteins which can be recognized by African AIDS patients, considering the HIV clades and the HLA genotypes present in the Ivory Coast. The research concept for a combined post-exposure vaccine based on synthetic HIV peptides has been developed by Dr. Vittorio Colizzi and his collaborators at the University of Rome "Tor Vergata" and at the UNESCO Laboratory established in 1998 by Dr. Montagnier at the Italian Institute for Infectious Diseases "L. Spallanzani" in cooperation with the Italian National Council (CNR). The practical aspect of this approach is that HIV peptides will be incorporated and associated to BCG, a vaccine used in newborns to induce protection against tuberculosis. This vaccine may be particularly helpful in the prevention of HIV vertical mother-to-child transmission in Africa. Both tat and nef are critical regulators of HIV infection and the scientists believe they are also released by infected cells and contribute to the impairment of an immune response against HIV.

In another approach, Dr. Montagnier, Dr. Thibodeau and colleagues in Montreal, are also developing a vaccine generating in animal models broadly neutralizing antibodies based on a genetically modified HIV envelope protein.

"By pooling resources and working in partnership on an international level, we can more quickly move these concepts forward at a level that will have a more immediate global impact," says Dr. Montagnier, "and we have the duty to facilitate transfer of knowledge working together with scientists and researchers from developing countries. HIV is an almost impossible virus to mastermind and it may not be possible until we come together, sharing our insights and moving forward together to advance this goal."

These efforts in research will be accompanied by activities concerning preventive education and training for transfer of scientific knowledge to make researchers in the developing countries players on the stage of stopping HIV/AIDS through cooperation with UNESCO.

Gallo and Montagnier have been colleagues for more than two decades and share a storied relationship that hasn't been without complications and conflict.

In 1983-84, both laboratories discovered the cause of AIDS. HIV (then called by different names) was first discovered in 1983 in Montagnier's laboratory. In the same year, several independent isolates of HIV were identified in Gallo's laboratory; this was reported in 1984. Both labs also provided the conclusive evidence that this virus was the cause of AIDS.

Both groups also contributed to the development of the blood test for HIV, which allowed the AIDS epidemic to be monitored for the first time and provided a screening mechanism to ensure safe blood transfusions to prevent the spread of HIV, which saved the lives of tens of thousands of people. The evidence of the causative role of HIV in AIDS and early testing for HIV made counseling and early treatment possible, thereby also benefiting the lives of millions around the world. (Prior to the HIV blood test, public health officials needed to see visible clinical evidence of AIDS, which generally takes 5 to 15 years).

Much public attention was given to this sequence of events. The particularly virulent HIV strain used for the blood tests was the source of accidental contamination in both laboratories in those early years of HIV research.

"Such events," explains Dr. Montagnier, "which are not exceptional did not affect the science nor the scientific contributions of either group, but it has occasionally been used to disparage the integrity of our research."

"Controversy surrounded what was in fact a sustained and extraordinarily productive period in international science," adds Dr. Gallo. Both scientists agree that it is now most important to move forward and make history, not rehash it. "We are friends and collaborators and we look forward to this new chapter in which we both strive for new solutions - which the whole world awaits -- in halting the destructive path of HIV/AIDS."