Press Release

A public statement from the Global Campaign for Microbicides and the AIDS Vaccines Advocacy Coalition on the impact of stopping Tenofovir trials in Cambodia and Cameroon

Recently clinical trials have been launched in Africa, Asia and the United States to explore the potential use of oral Tenofovir as a “once a day” pill to prevent HIV in uninfected individuals – an intervention known as pre-exposure prophylaxis (PREP). Yet concerns from a few activists opposed to these efforts have resulted in government decisions to halt the trials in Cambodia and Cameroon.

The decisions to halt the trials have generated a firestorm of controversy in the HIV/AIDS treatment, prevention, advocacy, and research communities. In both countries, the public allegations criticizing the trials were not completely evidence-based, and the media’s coverage was highly provocative. As a result, government decisions to stop the trials may have been premature.

Left unchecked, these forces threaten to undermine future trials. The cost is paid in people’s lives – the lives of those who might benefit from new technologies or treatments. This is not to say that unethical research should proceed. But derailing trials without high levels of evidence to support the claim that they are unethical, is a costly practice.

The Global Campaign for Microbicides and the AIDS Vaccines Advocacy Coalition (AVAC) are international networks of advocates who have worked to forge meaningful collaborations between researchers, communities and activists. Both organizations are committed to ensuring that as science proceeds, the public interest is protected and the rights and interests of trial participants, users, and communities are fully represented and respected. Good prevention research must be accelerated, must be ethical, must involve communities and must result in products accessible and acceptable to the people who need them most.
We are convinced that the concerns raised by those who oppose the trials are solvable and need not have resulted in stopping trials. Issues can and should be addressed by researchers and sponsors working collaboratively with local communities and governments. Controversy over the ethics of research is an opportunity to engage communities in partnership. As Gregg Gonsalves of Gay Men’s Health Crisis recently noted, shutting down an HIV prevention study “is not a victory – it is a defeat. A victory would have been to be able to craft a solution to fix the local study.”

In this spirit, the Global Campaign and AVAC are planning to generate various materials that accurately reflect current events, assist all stakeholders with working though these issues and provide specific recommendations to accelerate ethical development of new technologies. Among the materials we will produce are:
�    A fact-sheet designed to correct some of the common misperceptions and errors of fact that have been made in the course of public discussion of these trials. This fact sheet will be available on our websites (http://www.global-campaign.org/ and http://www.avac.org/) in the next few weeks.
�    A background document that attempts to articulate the basics about Tenofovir, the current PREP studies and the various issues involved will be available in early March.
�    Two on-the-ground case studies to document what actually happened in Cambodia and Cameroon from each sector’s perspective, to identify lessons learned that could help prevent similar situations in the future. This project is already underway, and we hope to have these materials available in the coming three months.

The following key principles are pivotal:
1.    The HIV pandemic creates an incredibly urgent demand for additional safe and effective tools with which to treat HIV infection and stop transmission. This can only be achieved by responsible, credible scientific studies.
2.    Research to create these tools must be done in a way that protects the rights of vulnerable populations and contributes to overcoming the global imbalance in access to health care resources.
3.    Communities affected by research must be actively involved in its conceptualization and implementation.
4.    The rights of trial participants should be respected and participants should be admired for their contribution to helping others.
5.    Researchers and funding agencies must be held accountable for their studies, and advocates must demand that problems be resolved.
6.    AVAC and the Global Campaign are dedicated to developing effective collaborations among a broad range of civil society actors, researchers and sponsors.
We cannot combat AIDS effectively without research and development of new technologies. Without clinical trials, we cannot know what does and does not work – or how different drugs and interventions work in various populations and settings. This means wrestling, collectively and collaboratively, with the complexities of designing trials that are simultaneously ethical and scientifically rigorous. Simply objecting to existing trial designs and shutting down trials is not a solution. We must, instead, proceed with the much harder job of shaping a research standard we can support and then demanding that trials be designed and adequately funded to meet that standard.

For more information:
�    AIDS Vaccine Advocacy Coalition (AVAC): Mitchell Warren, Executive Director, mitchell@avac.org, +1 (212) 367-1084, http://www.avac.org/

�    Global Campaign for Microbicides: Lori Heise, Executive Director, lheise@path-dc.org, +1 (202) 822-0033, http://www.global-campaign.org/

Press Release

AIDS Advocates Partner to Involve African Americans in search for an AIDS vaccine

LOS ANGELES and NEW YORK, February 7, 2005 — In recognition of National Black HIV/AIDS Awareness Day, the AIDS Vaccine Advocacy Coalition (AVAC) and the Black AIDS Institute (the Institute) are pleased to announce the release of Myths About HIV Vaccines and Vaccine Research, a fact sheet that addresses misconceptions in African American communities about the search for a preventive HIV vaccine.

This fact sheet is part of a partnership between the Institute and AVAC to ensure that African Americans are involved in research efforts to develop vaccines for HIV/AIDS. The fact sheet is available on-line at http://www.blackaids.org/.

The US Centers for Disease Control and Prevention (CDC) reported 69% of women who tested HIV-positive between 2000 and 2003 were African American. Similarly, African American men had the highest rate of new HIV/AIDS diagnosis among all other racial/ethnic groups in 2003, seven times that of their white counterparts. For African Americans and all communities highly impacted by HIV/AIDS, an effective vaccine could make the difference between life and death.

“One thing we clearly learned from the first large-scale clinical trial of an experimental vaccine for HIV was that African Americans and other communities of color highly impacted by HIV must be represented,” said Edd Lee, AVAC’s Director of Community Education & Outreach.

Recognizing this, AIDS vaccines have been a core component of the Institute’s African American HIV University (AAHU) curriculum, ensuring African American AIDS experts are informed and prepared to tackle the issues of HIV vaccine research.

“This is a great example of how strategic partnerships can create needed resources for communities — AVAC brings expertise in AIDS vaccine research, we bring expertise in African American HIV capacity building, and in the end it is the community that benefits,” said Antonne Moore, Director of Programming for the Institute.

AAHU is a comprehensive training and internship program to decrease stigma and misperception and increase HIV science literacy in Black communities. The Institute is currently accepting applications for the next AAHU session. The deadline for submissions is February 11, 2005, and applications can be found at http://www.blackaids.org/.

About the Black AIDS Institute: The Institute’s mission is to stop the AIDS pandemic in Black communities by engaging and mobilizing Black institutions and individuals in efforts to confront HIV. The Institute interprets public and private sector HIV policies, conducts trainings, offers technical assistance, disseminates information and provides advocacy from a uniquely and unapologetically Black point of view.

About the AIDS Vaccine Advocacy Coalition (AVAC): AVAC is a not-for-profit, non-partisan community organization dedicated to accelerating the ethical development and global delivery of vaccines for HIV/AIDS. For more information, visit http://www.avac.org/.

Press Release

AIDS Vaccine Advocates Hail South African Focus on Youth

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.”

Press Release

Advocacy Group Voices Disappointment: Calls for Reinvigorated Effort to Design and Test AIDS Vaccines

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/.

Press Release

Advocacy Group Issues Guide to Forthcoming AIDS Vaccine Trial Results

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 avac@avac.org. 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.

Press Release

Medicines Control Council Begins Phase I Clinical Trial of South Africa’s First AIDS Vaccine

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.

Press Release

New Industry Survey Finds Need for Increased Government Role in Search for AIDS Vaccine

  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/.

Press Release

Advocacy Group Praises Merck-Aventis Pasteur Vaccine Collaboration

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.

Press Release

Vaccine Fails to Show Efficacy: Data from subgroup analysis is intriguing But drawing conclusions would raise false hopes

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.

Press Release

AIDS Vaccine Advocacy Coalition (AVAC) Announces Appointment of Director of Science Communication and Advocacy

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.