February 04, 2002
Novel vaccine candidate can be administered orally;
expected to be inexpensive to manufacture, easy to store and transport
BERNE, Switzerland, and NEW YORK, 4 February 2002—Swiss vaccine manufacturer Berna Biotech Ltd. has joined a cross-national team to test a new vaccine to prevent HIV infection and AIDS designed specifically for use in developing countries. Berna will produce doses of the vaccine for human trials starting this year in Uganda and the US. This public-private partnership to speed AIDS vaccine science was announced at the World Economic Forum in New York.
Under the leadership of Dr. Robert Gallo, credited with the co-discovery of HIV, and Dr. George Lewis, the vaccine is in the final stages of laboratory development at the Institute of Human Virology (IHV), a center of the University of Maryland Biotechnology Institute in Baltimore, Maryland. Development and testing of the vaccine are being pursued with financial and scientific backing from the International AIDS Vaccine Initiative (IAVI).
Berna is developing new manufacturing processes for the novel vaccine, which consists of synthetic pieces of HIV’s genetic material inserted into weakened bacteria.
Berna adds Switzerland to a growing roster of European companies working with IAVI to accelerate progress toward finding an AIDS vaccine. On other vaccine projects, IAVI is partnering with manufacturing firms in the UK and Germany as well in Africa, India and the US. In addition, the governments of the UK, Netherlands, Ireland, Norway and Denmark as well as Canada and the US have pledged direct monetary support to IAVI.
The IAVI-IHV vaccine has been tailored for optimal use in developing countries:
- The techniques needed to manufacture the vaccine are relatively inexpensive.
- The formulation is designed to facilitate storage and transportation in developing countries.
- The vaccine can be administered orally, without the need for injection equipment.
In addition, the vaccine is expected to engage the arm of the human immune system that protects the mucous membranes of the genitalia. This could be critical in preventing heterosexual transmission of HIV, the dominant mode of infection in developing countries.
“A preventive AIDS vaccine is the world’s best hope to stop the spread of the deadly epidemic. We have both a moral and public health obligation to develop a vaccine that is safe and effective as well as practical for use where it is needed most,” said Dr. Seth Berkley, President and CEO of IAVI.
The United Nations estimates that in sub-Saharan Africa alone, nearly 10,000 people are infected with HIV each day. In southeast Asia, an additional 5,000 new infections occur daily. Yet many of these countries spend no more than US$10 per person annually for all health care expenses.
“From the beginning, this vaccine was designed to keep manufacturing and delivery costs down and to be administered in the easiest way,” said Dr. Reinhard Glück, Head of Research and Development for Berna. “An AIDS vaccine with a high price tag and that is difficult to administer would be of little help in most regions.”
“Our shared goal is to develop a less costly AIDS vaccine that will be readily available for prevention efforts worldwide,” said Dr. Gallo, whose research center is collaborating in the study of other AIDS vaccine candidates as well. “We are very excited about the progression of this vaccine into human trials and are delighted that our early seminal research helped form the basis for this novel approach.”
Like other AIDS vaccines in development, the IAVI-IHV vaccine is intended to immunize individuals uninfected with HIV against the chance of future exposure to the virus. The vaccine does not contain whole HIV but rather only small pieces of it, specifically, synthetic units of the virus’s gag gene inserted into weakened bacteria. While these pieces of the virus cannot cause disease, the hope is that they will mimic exposure and stimulate the immune system to build capabilities that could fight off a real HIV infection.
With different strains of HIV circulating worldwide, researchers do not yet know if it is possible to make one AIDS vaccine that works against all variants of the virus, or if multiple vaccines will be needed. For this reason, this vaccine is constructed from subtype A of HIV, a strain of the virus predominant in East Africa. Most other AIDS vaccines are built for subtype B, common in industrialized countries but rare elsewhere. This vaccine, which will be tested in conjunction with the Uganda Virus Research Institute in Entebbe under the direction of Dr. Pontiano Kaleebu, will be only the second for HIV-A to enter human testing.
The International AIDS Vaccine Initiative (IAVI, www.iavi.org) is a global nonprofit organization working to speed scientific progress toward finding safe, effective and accessible preventive AIDS vaccines. To date, IAVI has invested more than US$35 million in six cross-national product development teams, each pursuing one or more AIDS vaccine possibilities for Africa or Asia. IAVI also works to guarantee that AIDS vaccines, once found, will be swiftly distributed to all who need them.
IAVI, founded in 1996, has drawn major support from the Bill & Melinda Gates Foundation; the Rockefeller, Sloan and Starr foundations; the World Bank; BD (Becton, Dickinson and Company); and the governments of the United Kingdom, Netherlands, Canada, Ireland, United States, Norway and Denmark. IAVI is a collaborating centre of UNAIDS.
About Berna Biotech Ltd.
Berna Biotech Ltd. (www.bernabiotech.com), founded in 1898 as the Swiss Serum and Vaccine Institute Berne, is an independent biotechnology company in the field of immunization. Berna has outstanding expertise and experience in the development and production of bacterial and viral vaccines designed for oral administration and the induction of mucosal immunity. Based in Berne with subsidiaries in Italy, Spain and Switzerland, the company employs more than 700 people and has generated a turnover of around CHF 200 million and a profit before restructuring costs of CHF 4.8 million in the year 2000. Berna Biotech is a public company with a broad shareholder base. Its shares are listed on the SWX Local Caps index.
About the Institute of Human Virology
The Institute of Human Virology (IHV, www.ihv.org) was established to create and develop a world-class center of excellence focusing on chronic viral diseases and virally linked cancers. IHV is dedicated to discovery, research, treatment and prevention of these diseases and cancers. The Institute was formed in 1996 as a partnership among the State of Maryland, the City of Baltimore, the University System of Maryland and the University of Maryland Medical System. It is a center of the University of Maryland Biotechnology Institute and affiliated with University of Maryland Medicine.
About the Uganda Virus Research Institute
The Uganda Virus Research Institute, founded in 1936, is a government institution under the Ministry of Health whose broad mission is to carry out scientific research concerning communicable diseases, especially viral diseases of public health importance, and to advise the government on strategies for control and prevention. A number of international organizations are collaborating with UVRI on HIV research. UVRI serves as a World Health Organization primary laboratory for HIV-1 isolation and characterization.