This guide is designed to help readers gain a better understanding of the ethical issues involved in developing a preventive HIV vaccine. While much of the guide is intended for a prospective clinical trial participant, it provides a basic introduction for anyone who wants to learn more about ethical issues and HIV vaccine development.
Finding Your Way: A guide to understanding ethical issues related to participation in clinical trials for preventive HIV vaccines
AIDS Vaccine Handbook: 2nd edition, Global perspectives
The Handbook provides comprehensive introductory material on the key scientific, policy, social, ethical and economic facets of AIDS vaccine research. While the science has changed greatly over the decade since this second edition of the Handbook was published in 2005, the themes and content in many of the essays still hold true. Edited by Patricia Kahn, the handbook contains articles by community educators and advocates, trial staff and volunteers, scientists and researchers, and policy makers and journalists.
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.”
2003 AVAC Report: 4 Years and Counting: How do you Fight a Disease of Mass Destruction?
When America became frightened by the bio-terror threat, Congress and the Administration moved swiftly to put funding and incentives in place. That same kind of decisive action is needed to accelerate research and ensure an AIDS vaccine is available to all who need it. This Report looks at the bioterror model, and provides the results of our new industry survey.
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 [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.
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.