NEW YORK — The AIDS Vaccine Advocacy Coalition (AVAC) praised a new partnership between the Nelson Mandela Foundation and the South African AIDS Vaccine Initiative (SAAVI), which was announced today in Johannesburg.

“This is an important step forward in advancing a comprehensive approach to HIV prevention, including the development of an AIDS vaccine, in South Africa,” said Mitchell Warren, AVAC executive director. “We are especially excited about this new partnership and its focus on ensuring that a vaccine licensed for adults also be made available to adolescents in a timely way.”

“Young people between the ages of 15 and 24 account for half of all new cases of HIV in the world,” Warren said. “In South Africa, the Mandela Foundation and SAAVI are now taking the lead to make adolescents a top priority in HIV vaccine development.”

AVAC, a non-profit advocacy group that works to speed the ethical development of AIDS vaccines, issued a report in May that called for the inclusion of adolescents in clinical trials of promising AIDS vaccine candidates that have reached the final stages of testing in adults.

Despite the fact that many teenagers around the world are at high risk of HIV, adolescents have generally been excluded from AIDS vaccine trials because of ethical, legal and logistic concerns.

“Although the inclusion of adolescents raises challenging issues, these are all solvable issues  — and they must be solved if we are to develop a vaccine that can reach those most at risk of HIV in a timely way,” Warren said.

He noted that two pharmaceutical companies, Merck & Co. and GlaxoSmithKline, are now conducting large international trials of their STD vaccines among adolescents.  

The full AVAC Report, including the chapter on adolescents, is available at http://www.avac.org.  It is titled “AIDS Vaccine Trials — Getting the Global House in Order.”

NEW YORK – The AIDS Vaccine Advocacy Coalition (AVAC) today expressed disappointment that the second Phase III trial of an AIDS vaccine did not show efficacy of the candidate vaccine, AIDSVAX. The trial tested AIDSVAX among 2,546 injection drug users in Thailand.

“We are disappointed that AIDSVAX alone did not prove efficacious in this population in Thailand,” said Chris Collins, Executive Director of AVAC. “This trial was not a failure because it tested a product and produced a result. More efficacy trials like the Thai AIDSVAX trial need to be run. Sometimes the results from those trials will be disappointing, but all of us need to be prepared for the long haul to find a vaccine against the biggest infectious disease killer.”

The Thai trial tested AIDSVAX B/E, a version of the vaccine modeled after two strains of HIV – the “B” strain and “E” strain – both found in the Thai population.

“Now is the time to reinvigorate AIDS vaccine research,” Collins said. “Research funding is still woefully inadequate, industry must become more engaged, global clinical trials capacity is insufficient, and there are no real plans to make an AIDS vaccine universally accessible.”

“AVAC applauds the continuing leadership of the Thai government on AIDS prevention, treatment and research, as well as the contributions of the thousands of individuals enrolled in the AIDSVAX trial,” Collins said. “VaxGen’s accomplishment should not be underestimated. Twenty-two years into the epidemic, the company sponsored the first AIDS vaccine efficacy trials and it demonstrated these trials could be completed successfully.”

AVAC is an eight year old community and consumer based advocacy organization dedicated to accelerating the ethical development and global delivery of vaccines against AIDS. The organization is funded by the Bill and Melinda Gates Foundation, the Ford Foundation, the International AIDS Vaccine Initiative, Until There’s a Cure Foundation, Broadway Cares/Equity Fights AIDS, the Gill Foundation, and many generous AVAC Members. More information on AVAC and the AVAC Report are available at http://www.avac.org/.

NEW YORK – The AIDS Vaccine Advocacy Coalition (AVAC) today released a guide for the public on the forthcoming results of the world’s first AIDS vaccine efficacy trial. Results of the clinical trial of AIDSVAX, made by the biopharmaceutical company VaxGen, are expected to be released early in 2003.

The AVAC guide is available in hard copy and can be requested by writing [email protected]. It is also available on the web at www.avac.org/pdf/results_of_the_AIDSVAX_trial.pdf.

“It is critical that the public, policy makers, and the media are prepared to put the outcome of the AIDSVAX trial in context,” said Chris Collins, AVAC’s Executive Director. “This vaccine has been the subject of both skepticism and optimism. Whether AIDSVAX proves efficacious or not, clinical research like this trial is essential to moving the field of AIDS vaccines forward.”

“Whatever the news about AIDSVAX, a highly effective, globally available vaccine against AIDS is years away,” Collins said. “Political leaders and the public must understand that expanded research, product development and testing, as well as stepped up efforts to make treatments and vaccines globally accessible, are critical to fighting the AIDS pandemic.”

“AVAC congratulates VaxGen on its groundbreaking work,” Collins said. “The VaxGen trial in North America, Puerto Rico and Europe, as well as its sister trial in Thailand, have advanced the field of AIDS vaccine research by proving efficacy trials can be done in the US and internationally. These trials should yield important lessons about clinical trial planning and preparation, infrastructure needs, ethics, recruitment, and community involvement.”

AVAC is a seven year old community and consumer based advocacy organization dedicated to accelerating the ethical development and global delivery of vaccines against AIDS. The organization does not accept funding from government or the pharmaceutical industry. AVAC’s work is supported by the Bill and Melinda Gates Foundation, the Ford Foundation, the International AIDS Vaccine Initiative, Until There’s a Cure Foundation, Broadway Cares/Equity Fights AIDS, the Gill Foundation, and many generous AVAC Members.

NEW YORK – The AIDS Vaccine Advocacy Coalition (AVAC) yesterday applauded South Africa’s Medicines Control Council for giving the go-ahead to a long-awaited Phase I clinical trial of the countrys first AIDS vaccine.

South African regulatory approval of the small safety study of the vaccine, made public today, clears the way for testing of the first HIV vaccine tailor-made to combat the particular strain of AIDS virus circulating in South Africa, which has 4.5 million people living with HIV, more than any other country.

Besides South Africa, the clade C strain of the virus is also found in Botswana, Zambia, Zimbabwe, Mozambique, Malawi and the southern part of Tanzania. If successful, a vaccine for that region could have an enormous impact on the AIDS pandemic.

“This is wonderful news,” said Huntly Collins, AVAC’s director of science communication and advocacy. “Though it will be years before we know whether the vaccine actually works, it is one of the more promising scientific approaches.”

The vaccine is the first anywhere made with C clade virus. Most experimental AIDS vaccines have been made with the strain of HIV circulating in the United States rather than in developing countries, where the majority of HIV infections are occurring.

The product, manufactured by AlphaVax Inc., of Durham, N.C., uses virus-like particles to deliver HIV genetic material to human cells. It was jointly developed by South African scientists and researchers at the University of North Carolina.

It is to be tested among 96 uninfected volunteers, half in South Africa and half in the United States. The joint trial will begin first in the U.S., probably in July, and then start in Johannesburg and Durban, South Africa.

The U.S. testing sites are at Johns Hopkins University, Columbia University, the University of Rochester and Vanderbilt University. The principal investigator of the trial in the U.S. is Dr. Donald Burke at Hopkins. The principal investigator in South Africa is Dr. Glenda Gray at Chris Hani Baragwanath Hospital in Soweto, just outside Johannesburg.

The vaccine is aimed at stimulating infection-fighting white blood cells to combat HIV. Though it may not provide sterilizing immunity, it could keep HIV in check so that infected people don’t become ill.

The viral particles that will be used as vectors to deliver the vaccine are made from Venezuelan equine encephalitis virus (VEE), which infects horses. It has been disabled so it can’t cause disease in humans.

Two other HIV vaccine candidates, one made by Merck & Co. and another sponsored by the International AIDS Vaccine Initiative, are awaiting approval by South Africas Medicines Control Council. Neither of those vaccines is made with Clade C virus.

A Phase I trial of the AlphaVax vaccine was approved by the U.S. Food and Administration on April 30. The product has been awaiting final approval by South Africa before moving ahead into human testing.

AVAC encouraged South Africas Medicines Control Council to accelerate its approval process for the two other vaccines in the pipeline.

“As the country suffering the most from HIV, South Africa needs to move as swiftly as possible to test all HIV vaccine candidates that have scientific merit and have proven safe in preliminary animal tests,” Collins said.

AVAC is a private, non-profit organization that provides objective analysis of AIDS vaccine candidates and works to accelerate the ethical testing and global access to AIDS vaccines. It is funded by the Bill & Melinda Gates Foundation, Ford Foundation, International AIDS Vaccine Initiative, Until There’s a Cure Foundation, Broadway Cares/Equity Fights AIDS, Gill Foundation and AVAC Members. AVAC accepts no government or industry funds.

  Advocacy Group Calls on Congress to Apply Bioterror Incentives in Battle Against Global Infectious Disease

NEW YORK – Private industry is stepping up its quest for an AIDS vaccine, but it needs increased government support to maintain the momentum, according to findings of a new survey released today by the non-profit AIDS Vaccine Advocacy Coalition (AVAC), a watchdog group that accepts no government or industry funding.

The AVAC survey of 11 pharmaceutical and biotech companies engaged in AIDS vaccine research found that more public-sector funding was needed to expand product development and manufacturing, increase the number of international sites where AIDS vaccine trials can be conducted, and guarantee the purchase of AIDS vaccines for rapid global delivery.

“When America became frightened by the bio-terror threat, Congress and the Administration moved swiftly to put funding and incentives in place,” said Chris Collins, AVAC’s Executive Director. “That same kind of decisive action is needed to accelerate research and ensure an AIDS vaccine is available to all who need it.”

Collins criticized a recent decision by the Bush administration directing cuts in research grants for AIDS and other infectious diseases in order to buy 25 million doses of anthrax vaccine. “We simply can’t afford to pit one global health threat against another,” Collins said.

Results of the AVAC survey were released as part of the group’s annual report on the status of AIDS vaccine research. Titled How Do You Fight a Disease of Mass Destruction?, the report includes in-depth articles on delays in getting AIDS vaccines into clinical trials, concerns about whether there are too many “me too” (or similar) products in the pipeline, and the work of the federal government’s Dale and Betty Bumpers Vaccine Research Center. This year’s report also includes an in-depth look at why the world’s first vaccine tailored to combat HIV in South Africa, which has more AIDS cases than any other country, has been stalled for more than a year in entering human trials.

The AVAC report recommends increased funding for the National Institutes of Health and the Food and Drug Administration, stepped up assistance to product developers, and expanded clinical trials capacity internationally.

AVAC will host a reception to release the new report from 5 p.m. to 7 p.m. tonight at the Marlborough Gallery at 211 West 19th Street, New York City.

AVAC is an eight year old community and consumer based advocacy organization dedicated to accelerating the ethical development and global delivery of vaccines against AIDS. The organization is supported by the Bill and Melinda Gates Foundation, the Ford Foundation, the International AIDS Vaccine Initiative, Until There’s a Cure Foundation, Broadway Cares/Equity Fights AIDS, the Gill Foundation, and many generous AVAC Members. More information on AVAC and the AVAC Report are available at http://www.avac.org/.

NEW YORK – The AIDS Vaccine Advocacy Coalition (AVAC) today said it is encouraged by the announcement that Merck & Co. would team up with Aventis Pasteur to work on a potential AIDS vaccine.

“This partnership will bring together some of the most thoughtful scientific minds working on HIV vaccines at two of the largest vaccine manufacturers in the world,” said Chris Collins, AVAC’s Executive Director. “The AIDS vaccine field needs more willingness on the part of product developers to work collaboratively and share lessons learned.”

Under an agreement announced today, the companies will combine products that each of them has developed separately and test them as a prime-boost vaccine. The prime will be with Merck’s adenovirus-vectored vaccine and the boost will be with Aventis’ ALVAC-vectored vaccine, which uses an attenuated bird virus to shuttle HIV genes into human cells.

Collins said he hoped the partnership would extend beyond existing vaccine candidates already on the shelves of these two specific companies. “Hopefully this collaboration will lead to better understanding of how prime-boost approaches work and how they can be optimized.” Collins said. “Considerations of proprietary information or product ownership run the risk of impeding research on AIDS vaccines. The Merck/Aventis partnership is a step in the right direction.”

AVAC is a community and consumer based organization dedicated to accelerating the ethical development and global delivery of AIDS vaccines. AVAC provides education, analysis and advocacy to advance AIDS vaccine research. The organization does not accept funding from government or the pharmaceutical industry. AVAC is supported by the Bill & Melinda Gates Foundation, the Ford Foundation, the International AIDS Vaccine Initiative, Until There’s a Cure Foundation, Gill Foundation, Broadway Cares/Equity Fights and many generous AVAC Members.

NEW YORK – The AIDS Vaccine Advocacy Coalition (AVAC) today expressed disappointment that the first efficacy trial of an AIDS vaccine failed to show protection in the study population. The trial was of the vaccine candidate AIDSVAX that is made by VaxGen.

“Of course it’s unfortunate that AIDSVAX did not demonstrate efficacy in the study population of over 5000 men who have sex with men and over 300 women at risk of HIV infection,” said Chris Collins, Executive Director of AVAC. “But this trial should not be characterized as a failed effort. More human trials of better candidates in several countries will likely be necessary to identify an AIDS vaccine.”

“The AIDSVAX results did provide surprising data in the sub-population of African American trial participants,” Collins said. “But the trial simply was not designed to demonstrate efficacy in this subgroup and the numbers of participants in this group are too small to draw any conclusions about the vaccine’s effects in this subpopulation.”

“The African American community has been devastated by AIDS, and finding a vaccine that could protect African Americans would be truly outstanding,” Collins said. “But given the overall finding, at this stage in the data analysis, it would be hazardous to jump to conclusions about what the AIDSVAX data mean for this subgroup. Such premature conclusions run the risk of raising false hopes in a world desperate for an AIDS vaccine. Further examination, and perhaps further trials, are necessary before conclusions can be drawn.”

There are over 20 other AIDS vaccine candidates in or nearing clinical trials and several are considered more promising than AIDSVAX. These candidate vaccines use multiple different approaches to protect from HIV. “AIDS vaccine research is a long term effort,” Collins said. “The North American AIDSVAX trial has been one important step in that effort.”

AVAC is a community and consumer based organization dedicated to accelerating the ethical development and global delivery of AIDS vaccines. AVAC provides education, analysis and advocacy to advance AIDS vaccine research. The organization does not accept funding from government or the pharmaceutical industry. AVAC is supported by the Bill & Melinda Gates Foundation, the Ford Foundation, the International AIDS Vaccine Initiative, Until There’s a Cure Foundation, Gill Foundation, Broadway Cares/Equity Fights and many generous AVAC Members.

NEW YORK – The AIDS Vaccine Advocacy Coalition (AVAC) today announced the appointment of Huntly Collins as its first Director of Science Communication and Advocacy. Ms. Collins was a respected staff writer at The Philadelphia Inquirer from 1983 to 2001, where she covered public health and AIDS among other issues.

“Huntly is an investigative journalist and science writer of the first rank,” said Chris Collins, Executive Director at AVAC. “She brings an ability to critically analyze scientific issues and clearly communicate on those issues. Huntly is widely known for her persistence and accuracy, as well as her passion for public health. She will be an effective advocate for accelerated, ethical AIDS vaccine research.” Huntly Collins and Chris Collins are not related.

Ms. Collins, whose journalistic career spans three decades, said she joined AVAC because of its mission and its commitment to providing accurate, fair and unbiased information about AIDS vaccine development. “With money, politics and prestige influencing the quest for an AIDS vaccine, it’s more important than ever that stakeholders and the general public have a reliable source of factual information about experimental vaccine candidates and issues surrounding their ethical testing in clinical trials both in the United States and abroad,” she said.

Ms. Collins, who began her journalism career as an investigative reporter for The Oregon Times magazine, spent nine years as a reporter at The Oregonian in Portland before joining the staff of The Philadelphia Inquirer in 1983. She has been a Nieman Fellow at Harvard University, a Ford Fellow in educational journalism and a Kaiser Teaching Fellow in South Africa, where she mentored reporters covering AIDS. She holds a B.S. from Portland State University and an M.A. from the University of Missouri at Kansas City.

Ms. Collins lives in Philadelphia with her life partner, Esther Miller, a public-interest attorney, and their eight-year-old daughter, Mia Qian Miller Collins.

AVAC is an eight year old community and consumer based advocacy organization dedicated to accelerating the ethical development and global delivery of vaccines against AIDS. The organization does not accept funding from government or the pharmaceutical industry. AVAC’s work is supported by the Bill and Melinda Gates Foundation, the Ford Foundation, the International AIDS Vaccine Initiative, Until There’s a Cure Foundation, Broadway Cares/Equity Fights AIDS, the Gill Foundation, and many generous AVAC Members.

AVAC Announces Appointment of New Director of Education and Outreach

NEW YORK – The Ford Foundation today announced a $250,000 grant over two years to the AIDS Vaccine Advocacy Coalition (AVAC). Founded in 1995, AVAC is a community and consumer-based advocacy organization working to accelerate ethical development and delivery of AIDS vaccines to populations throughout the world.

AVAC also announced the appointment of Edd Lee as the new Director of Education and Outreach. Mr. Lee is currently the Associate Director of Prevention Services at Asian & Pacific Islander Wellness Center in San Francisco. He will start in his new role with AVAC in July.

“Community engagement is essential to moving AIDS vaccine research forward,” said Chris Collins, Executive Director at AVAC. “From pushing governments and industry to accelerate research, to monitoring the ethics of clinical trials, to insisting on rapid global access to vaccines, members of AIDS-affected communities have an important role to play. We thank the Ford Foundation for their support of this important work.” Resources provided by the Ford Foundation will help fund a variety of community outreach and mobilization activities designed to inform and engage communities on AIDS vaccine research.

“Community participation and trust is crucial to the development of AIDS vaccines,” said Edd Lee, AVAC’s new Director of Education and Outreach. “I am thrilled AVAC and the Ford Foundation are committed to community inclusion in AIDS vaccine development and I am proud to become a part of this effort. Many communities in the United States and around the world are concerned about past abuses in medical research and limited access to the benefits of health research. Community members need to be involved to assure ethical conduct of studies, protection of clinical trial participants, and equitable access to AIDS vaccines when they become available.”

The Ford Foundation is an independent, nonprofit grant making organization. For more than half a century it has been a resource for innovative people and institutions worldwide, guided by its goals to strengthen democratic values, reduce poverty and injustice, promote international cooperation, and advance human achievement. With headquarters in New York, the foundation has offices in Africa, the Middle East, Asia, Latin America, and Russia.

AVAC is a watchdog, education and advocacy organization that has become a leading national voice on AIDS vaccines. The organization is coordinating a Vaccine Community Session on July 11, 2002 as part of the upcoming International AIDS Conference in Barcelona. AVAC is supported by grants from The Bill and Melinda Gates Foundation, the Ford Foundation, the International AIDS Vaccine Initiative, Until There’s a Cure Foundation, Broadway Cares/Equity Fights AIDS, the Gill Foundation, and contributions from many individuals.

NEW YORK (May 17, 2002) – Today, the AIDS Vaccine Advocacy Coalition (AVAC) issued its fifth independent assessment of AIDS vaccine development from a community perspective. Entitled “Five Years & Counting; Science, Urgency and Courage,” the report finds that the campaign to identify an effective AIDS vaccine needs to move more candidate vaccines into clinical trials, and cites the pressing need for increased community engagement and public pressure to accelerate research efforts.

“Five years ago the White House issued a challenge to the nation – to develop an AIDS vaccine within a decade,” said AVAC Executive Director, Chris Collins. “This month we hit the halfway mark and many scientists believe we will not meet the deadline, or even come close.”

The report notes some positive scientific news on AIDS vaccines, but also identifies significant challenges ahead. Last winter, plans to move forward with an efficacy trial on one vaccine candidate were canceled when initial testing revealed disappointing immune responses among vaccine recipients. “HIV continues to spread at the alarming rate of nearly 14,000 new cases each day. Additional basic research, clinical trials and new, creative approaches to vaccine design are all badly needed,” said Michael Powell, PhD, Chair of the AVAC Board of Directors.

Need for More Clinical Trials
While AVAC’s review finds that the U.S. government’s HIV/AIDS vaccine research effort is now moving with increasing energy to develop products and move them into trials, past under-investment in AIDS vaccines by both government and industry has led to a gap in products ready for human testing today.

“There has been only one candidate AIDS vaccine available that is prepared to move forward into Phase III trials. This is only partly because of the significant challenges presented by HIV, but also due to the failure of public and private sectors to fully engage in the vaccine effort for many years or to focus on more than one approach at a time,” said Powell. “At last, there are now more vaccine candidates in the pipeline that need to be moved forward into clinical testing as swiftly as possible.”

The AVAC Fund
One specific measure that AVAC is undertaking is the AVAC Fund, which will award small-scale emergency grants to sites around the world embarking on HIV vaccine clinical research. The money will help purchase equipment and supplies not covered by research protocols, but needed to support the work of scientists and communities. Starting small, but promising ease and speed in its grant-making, the AVAC Fund is designed specifically to give ancillary support to sites in resource-limited settings that are struggling with the devastation of AIDS and taking on the added challenge of testing vaccines.

Signs of New Engagement
AVAC notes that several new programs are furthering developing countries’ involvement in AIDS vaccine research. AVAC lauds the creation of the NIH-funded Comprehensive International Program of Research on AIDS, whose mission is to ensure long-term funding for these countries’ researchers. In Botswana, the Harvard AIDS Institute has teamed up with the national government to create the Botswana Harvard Partnership for HIV Research and Education, where a vaccine initiative is a central component of this partnership.

In the United States, the NIH’s new Vaccine Research Center is now up and running and has entered its first AIDS vaccine into human testing. For the first time, some state governments are also making a contribution. Georgia, for example, uses lottery funds to support Emory University’s groundbreaking HIV vaccine research. Still, federal lawmakers have so far failed to pass incentives for research and development on vaccines against malaria, TB and HIV contained in the Vaccines for the New Millennium Act. The bipartisan legislation has been introduced by Rep. Nancy Pelosi and Senator John Kerry.

Call to Increase Public Pressure
The report identifies many improvements in vaccine research infrastructure and regulatory capacity that could be made, but which will require clear and consistent advocacy voices aimed at elected officials, regulatory agencies, scientists, industry, research funders and governments worldwide.

“As much as anything, what we need is public pressure and political will – to increase public and private funding, to ensure ethical research, and to run efficacy trials when products demonstrate safety and promising immune responses,” said Collins. “Only public insistence on accelerated, universal access can ensure that an AIDS vaccine conquers the global epidemic, rather than solely benefiting those that are fortunate to live in the world’s wealthiest nations.”

The AVAC report acknowledges that AIDS vaccine research is likely to be a long-term endeavor and must be pursued in the context of a comprehensive response to the pandemic. “In many ways, AIDS vaccine research can help blaze a trail in health care delivery today,” the AVAC report notes. “Communities that participate in AIDS vaccine research are making an enormous contribution to future global health; they deserve tangible benefits today.”

About the AIDS Vaccine Advocacy Coalition
AVAC is a seven-year-old alliance of advocates dedicated to accelerating the ethical development and global delivery of vaccines for AIDS. Volunteers are located throughout the country, with staff now based in New York City. Through its education and mobilization activities, AVAC stimulates public awareness of the critical need for AIDS vaccines.

AVAC does not accept funding from governments or the pharmaceutical industry. AVAC’s annual reports and ongoing policy, advocacy and outreach work are made possible by the dedicated labor of AVAC advocates and contributions from The Bill and Melinda Gates Foundation, the International AIDS Vaccine Initiative, Until There’s a Cure Foundation, Broadway Cares/Equity Fights AIDS, the Gill Foundation, and many generous individuals.

Attention Media
AVAC has created a membership program designed to provide reporters and others with updates on HIV vaccine issues from a community and consumer perspective. Contact AVAC at 212-367-1084 or [email protected].

Copies of “Five Years and Counting” are available from Lauren Mazzella, 212-581-2770 (x26) or [email protected]. They also may be downloaded from AVAC’s web site.