ADVOCATES FOR YOUTH

Imagine a World Without AIDS—HIV Vaccine Trials: Making the Dream a Reality

Participants' Statements
Tuesday, December 5, 2000

1. Mai T. Pham, International Youth Leadership Council, Advocates for Youth 
2. Marie-Emmanuelle (Emmie) Henry, International Youth Leadership Council, Advocates for Youth 
3. J. Lawrence Miller, Ph.D., Executive Director, Black Educational AIDS Project and AVAC Board Member 
4. Debra L. Hauser, M.P.H., Vice President, Advocates for Youth

Mai T. Pham

International Youth Leadership Council, Advocates for Youth

As a representative of the one billion young people worldwide, I am asking educators, policy makers, and parents to recognize that HIV/AIDS is devastating my generation—my peers are dying.

HIV/AIDS does not discriminate by race, gender, or age. Of the 5.3 million people newly infected with HIV, one-half are adolescents. Internationally, about five young people are infected with HIV every minute. In the 5 minutes since this press conference began, in the time it took for introductions to be made and statement begun, 25 young people have become infected with HIV. Sadly, most people living with HIV/AIDS are in developing countries, where they receive little or no treatment, and they will die.

As a resident of the United States with fairly traditional Asian parents, discussions about HIV/AIDS were not had with my parents. I took the initiative to learn about the dangers of HIV/AIDS. As a local college student in Washington DC, I have access to the information and services to protect myself from HIV/AIDS. Two summers ago I went to Vietnam to visit with my extended family. I have four cousins—ages 19, 17, 16, and 11, but would not be shocked to learn that they have never even heard of HIV. The silence around this epidemic is staggering. A study done in Indonesia showed that only 32% of youth had even heard of AIDS. This lack of information is killing us. I am frightened that my cousins, and many young people worldwide, are being kept in the dark about a disease that threatens their health and their lives.

Internationally, there is a general lack of education, resources, and care for young people who are vulnerable to or affected by HIV/AIDS. Young people are truly the heart of every nation, but they are denied the right to live their lives because they don't know. There is still too much misinformation about HIV/AIDS. Studies in Brazil and India show that despite a high level of awareness about of AIDS, youth are misinformed about the modes of HIV transmission, believing that HIV can be transmitted via casual contact, including sharing utensils and wearing the clothes of an infected person. In Columbia and Nigeria, many youth believe herbal medicines or soda and lime concoctions can cure sexually transmitted diseases.

There is also the problem of cultural limitations. In many cultures, girls are expected to be passive when it comes to making sexual decisions. In a study in Malawi, 57% of adolescent girls stated that it was easier to risk pregnancy and disease than to ask a boy to use a condom. Without the power to ask their partner to use a condom, or to make the choice to not have sex, young girls are at especially high risk for HIV infection. In some cultures boys are expected to prove their "manhood" by having sex at an extremely young age with prostitutes, or with as many partners as possible. These young men know nothing of the risks they are facing. There is simply a general lack of information about HIV/AIDS to allow young people to protect themselves. There is an urgent need for comprehensive sexuality education and services internationally.

The United States can and must do more to combat HIV/AIDS worldwide. When policy-makers speak of the "future generations" and the "young people of tomorrow", they must recognize that they can not just isolate America's youth, but they must include young people everywhere. HIV does not stop at country borders, and neither do today's youth. Young people worldwide need more money, more access to safe, confidential services, and more information to protect them from HIV/AIDS. As one young person among the one billion internationally, I ask you to recognize that HIV/AIDS is still a devastating international problem. HIV/AIDS is threatening the vitality of today's young people, the chances of tomorrow's youth, and the possibilities of the future international community. I am here today because I have made the choice not to let HIV/AIDS overshadow our future. I ask you to make the same choice.

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Marie-Emmanuelle (Emmie) Henry

International Youth Leadership Council, Advocates for Youth

The threat of AIDS in America is real. Future leaders are dying by the thousands. Advances in HIV/AIDS research means that people with HIV are living longer, but AIDS treatment does not equal HIV prevention. Every hour in the U.S., two young people contract HIV. AIDS is not over, and if we act like it is, it never will be. While we wait for science to produce a solution to the HIV epidemic, let's not forget to use the most powerful HIV/AIDS prevention tool that we have at our disposal right now—education.

I want to share a little story with you about a family called the Davidson's. The Davidson's just purchased a new home with a pool in the backyard. Mr. and Mrs. Davidson work full time and they are nervous that their two kids, neither of whom can swim, might come home from school, decide to play in the pool, and drown. So the Davidson's talk to the kids about the dangers of drowning and forbid them to go swimming. They even put up a locked fence to keep the kids out. This strategy works for a while as both Bob and Shelly are so scared of drowning that they stay out of the pool. As time goes by, fear turns into intrigue, and intrigue becomes curiosity. Every day Bob and Shelly are confronted with images of people swimming on TV as they watch shows like Baywatch. At school their friends talk about all of the different pool parties they've been to and how much fun they had. One day the kids decide to hop over the fence and go swimming. Sadly, Mr. and Mrs. Davidson's worst fears come true and both Bob and Shelly drown. The moral of the story: if you can't keep them out of the pool, you had better make sure they know how to swim.

When I talk about fences and pools in this day and age, this hypothetical story seems far-fetched. What if I changed a few of the variables? What if instead of the dangers of swimming, we were talking about the risks associated with having sex? What if instead of TV shows about swimming, Bob and Shelly were watching Sex and the City, the $treet, or G-string Divas? What if instead of talking about drowning, the Davidson's story talked about contracting a sexually transmitted disease like HIV/AIDS? What if I changed a few of the variables and told you that this story takes place every day, over and over again, in homes throughout the nation- homes like yours, homes like mine, homes like the Davidson's?

The lesson we should learn from the Davidson's story is this: If we aren't entirely certain we can prevent teens from having sex, we had better make sure they know how to protect themselves when they choose to become sexually active. The reality is, most teens make the choice to become sexually active. By the time they turn 18, almost 65% of young people will have had sex. Sadly, many make uninformed decisions placing themselves in high-risk situations. My childhood friend, James was one of those people. James contracted HIV from his high school girlfriend. He learned that he was HIV positive during his second semester junior year. While I was busy applying to colleges, James was dealing with taking his medication and staying healthy. While I was deciding what to do with my future, James was wondering

if he had a future. His story is the story of thousands of young people in America today. He, like so many of my peers, didn't believe he could become infected. Sadly, James has become another AIDS statistic. But we must remember that every statistic is someone's friend, someone's loved one, someone's child. How many friends do my peers and I have to lose before we are given the resources to protect ourselves from this deadly disease? So on James' behalf, and on behalf of young people throughout the United States, I ask parents, educators, and national leaders to give us the tools to be responsible. Help us to understand that the threat of AIDS is real. Let us make informed decisions. Give us a chance to save our lives, and the lives of our friends.

This year, 20,000 American youth will contract HIV. More than 130,000 15 to 34 year olds will die. In a country like America, where we have the resources to do something about the spread of HIV/AIDS let's act- and let's begin by educating young people and empowering them to educate each other. The fact of the matter is, young people are not just part of the problem. We are the solution. Every day that policymakers fail to recognize this, 55 of my peers contract HIV.

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J. Lawrence Miller, Ph.D.

Executive Director, Black Educational AIDS Project and AVAC Board Member

I represent the AIDS Vaccine Advocacy Coalition (AVAC). I am the Executive Director of the Black Educational AIDS project (BEAP), the oldest African American AIDS prevention group in Baltimore.

The young people have described the magnitude of the HIV/AIDS epidemic, especially in young persons in the United States. Worldwide, 5.3 million people were newly infected with HIV this year alone. A safe, effective preventive HIV/AIDS vaccine is the best way to end this global AIDS pandemic. Treatment and other prevention are vital, too. Vaccines are the cheapest, quickest, most effective, and maybe the only way to deal with many infectious diseases. Social progress to combat infectious diseases has been largely due to vaccines and sanitation. Further progress globally on infectious diseases requires vaccine development.

AVAC is a citizens' advocacy group with the mission to speed development of preventive HIV/AIDS vaccines. AVAC does this by analyzing obstacles to HIV vaccine development and advocating to overcome them. After almost 20 years of this epidemic, over 36 million people live with HIV. Yet, to date there's only one Phase III trial of a vaccine in the United States that might prevent this disease.

Let me give you some background about HIV vaccine development. Most scientists now believe that a vaccine against HIV/AIDS is possible. A vaccine is a substance that prepares or primes the body's own immune system to be ready to defend itself against an infectious agent that causes disease - whether a bacteria or virus. There are many successful vaccines—against diseases as diverse as smallpox, polio, diphtheria, tetanus, typhoid, hepatitis A and B, mumps, measles, and many more. There are many approaches to making preventive vaccines that are safe and effective. Traditionally, scientists used two methods: the first is a "whole killed" virus or bacteria that, when given to a person, causes the person's immune system to prepare itself to defend against the infectious bacteria or virus when the person became exposed to it in the future. Another approach—called "live attenuated"—used a version of the infectious agent—the virus or bacteria—that is changed or weakened in ways that keep it from causing the disease. The weakened virus prepares the body's immune system to protect itself when the person is later exposed to the actual virus or bacteria that causes the disease. Now scientists are using newer techniques to use genetically designed portions of a virus that cannot cause the disease but can prime (prepare) a person's immune system to defend against the disease causing virus.

Scientists are trying many approaches to develop an HIV/AIDS vaccine: there has been work on both "whole killed" and "live attenuated," but neither has reached the stage of human trials. There are, however, human trials currently underway in which scientists are testing the various vaccine candidates made from genetically engineered portions of the virus.

Let me describe the process of going from an idea to a licensed vaccine. Basic research underpins vaccine development for any infectious disease. Scientists study those who have had a disease and recovered; they look at what happens in a person's immune system—the antibodies or cellular immune response that the body mounts. Scientists then try different approaches—first in test tubes (in vitro), then in small lab animals, and next in larger animals (non human primates such as chimpanzees or monkeys) that have immune systems more like humans. Sometimes, scientists are able to identify and study an 'animal model'—that is, they find an animal that is affected by a virus similar to that that infects humans. The course of the disease is similar in the animal to the course the virus takes in humans. After an approach appears promising in vitro (in the lab) and in animals, safety testing is done. Initial safety tests are done in animals. Then Phase I trials are done—these require permission from the FDA (called an IND—investigative new drug)—and are done in small numbers, usually under 100 - of healthy volunteers. If a vaccine appears to be safe, then testing can move to Phase II, where additional safety studies and 'immunogenicity' studies are done. Immunogenicity means the vaccine causes the expected response in people—antibodies are produced or there is a cellular immune response. Phase II studies include healthy individuals at low and higher risk of HIV. After successful Phase I and II trials, testing can go to Phase III trials—done in many more volunteers. Phase III trials are designed to demonstrate efficacy. Or in other words, answer the question, "Does the vaccine protect against infection or disease?"

How do we know if a vaccine is efficacious in a Phase III trial for an HIV/AIDS vaccine? This is an important and difficult concept. Trials are double blind—neither the volunteers nor the researchers conducting the trials know which volunteers receive the vaccine and which receive a placebo—a substance is similar to the vaccine, but does not have any of the 'active ingredients'. Nothing in any AIDS vaccine being tested can give a volunteer HIV or AIDS. So how do we know if a vaccine being tested works or not? Large numbers of individuals who are at high risk of being exposed to HIV because of their behavior or activities are given either the test vaccine or the placebo. All volunteers are counseled to engage in behavior that will prevent HIV/AIDS (use condoms for intercourse, for example). During the period of the study—several years or more—individuals are followed, monitored for a variety of responses, and tested for HIV. Scientists know if a vaccine is effective by comparing the rate of actual HIV infections in the group getting the vaccine to the rate of infections in the placebo group. If a vaccine is effective, the group receiving it should have fewer infections than expected and less than the group getting the placebo. Scientists use statistics to determine how effective a particular vaccine is.

A quick review of what has happened so far in HIV/AIDS vaccine development shows there have been quite a few Phase I and Phase II trials. Vaxgen, a private company, is conducting phase III trials in the US and Thailand on a vaccine candidate called AIDSVAX, an approach that uses a genetically engineered portion of the envelope (outside—gp 120—glycoproteins) of the HIV virus. In the US there are approximately 5,000 volunteers, mostly men who have sex with men, in the VaxGen phase III trial. That trial does not include a single participant under 18 years old.

The National Institutes of Health (NIH) fund a network for conducting HIV/AIDS vaccine trials: the HIV Vaccine Trials Network (HVTN). This network is responsible for government-sponsored HIV trials. When we review the record of current and past HIV vaccine trials (only Phase I and Phase II trials, so far), only one of the 3,200 participants was under age 18.

The lack of youth participation is important to note. Sixty-five percent of all 18 year olds are already sexually active. For an HIV vaccine to have an impact on the incidence of this disease, it must be administered to individuals before they are placed at risk of acquiring the disease. That is, before they are sexually active. Yet, in current trials less than one percent of participants is under the age of 18. Without youth participation, we risk finding a vaccine that will be useful only for an adult population.

Today AVAC joins Advocates for Youth to call for two critical steps that will speed inclusion of young people in vaccine trials:

• First, the NIH must identify any scientific, legal, or procedural barriers to participation in trials by young people within the next 6 months and work with scientists, policymakers, and community groups to expeditiously overcome any barriers that are identified.
• Second, the HIV Vaccine Trials Network must include young people at every level in its community advisory boards, scientific committees, and protocol teams. The HVTN must create and fund a process that proactively includes young people in a community organizing effort for trial preparedness.

The NIH is currently considering proposals from academic centers to establish an Adolescent Trials Network (ATN). This is an important step that could make a contribution to speeding the inclusion of young persons in trials, but it does not itself guarantee anything. This network is supposed to conduct research, both independently and in collaboration with existing networks including the HVTN, on promising behavioral, microbicidal, prophylactic, therapeutic, and vaccine modalities in HIV-infected and HIV-at-risk adolescents, ages 12 through 24 years. This network and the HVTN must work together seamlessly to ensure the participation of young persons in HIV vaccine trials. The ATN and the HVTN must work with other groups addressing adolescent health needs to ensure today's youth get the best prevention and treatment interventions. These groups should include the CDC planning bodies, other research groups like the HIV Prevention Planning Trials Network (HPTN) and the Pediatric AIDS Clinical Trials Group (PACTG), privately funded youth organizations, and others. All of these groups must make sure today's youth have every opportunity to apply current knowledge of behavior changes to protect themselves and others from HIV infection.

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Debra L. Hauser, M.P.H.

Vice President, Advocates for Youth

Advocates for Youth is pleased to join with the AIDS Vaccine Advocacy Coalition in this important call to action.

For over 20 years, Advocates for Youth has worked diligently to insure that young people in the United States and in the developing world have access to the tools they need to make responsible decisions about sex. As such, Advocates believes that young people need access to comprehensive sexuality education, confidential reproductive and sexual health services, and a realizable stake in the future.

Young people are contracting HIV in great numbers. In the United States, as in sub Saharan Africa, young people under the age of 25 make up over 50 percent of all new infections. A teenager living in South Africa today has a 50 percent chance of dying from AIDS before his or her 35th birthday. Young African American women and young men who have sex with men in the United States, live with similar fear—each faces a disproportionate risk for contracting this infection.

Mai, a member of Advocates' Youth Council and one of the panelist, told us five young people become infected with HIV every minute of every day. She estimated that 25 young people had contracted the infection since her introduction her this morning. The clock has continued to tick—and by the time this press conference is over, almost 500 young people will have added their names to the ever-growing list of those infected with this deadly disease.

Yet young people are being left behind in one of the most promising avenues of research available to us today—research to find an effective HIV vaccine.

Dr. J. Lawrence Miller, Executive Director of the Black Educational AIDS project (BEAP), indicated that less than 1 percent of vaccine participants are under the age of 18. It is irresponsible, and in fact immoral, to continue conducting business as usual—to develop a vaccine tested entirely on adults and then to wait an additional five, ten, fifteen years before bringing to market a vaccine for youth.

Clearly, young people have the responsibility to protect themselves from contracting HIV in the present, but we, as a society, also have a responsibility—the responsibility to provide them with all of the tools necessary to safeguard their sexual health. To eradicate disease we must provide young people with access to HIV prevention education and services. Those already infected with the virus need ready access to effective drug treatment. Couple these strategies with an HIV vaccine that is safe and effective for young people and the dream will become a reality—HIV will go the way of small pox and polio. We must give young people the opportunity to participate in HIV vaccine research and to make certain that their participation is informed and voluntary. We must sort through and overcome the obstacles that keep us from creating a meaningful partnership with youth.

Ours is a society with a cultural propensity to view young people with little respect. Youth are often seen as part of the problem and rarely as part of the solution. But young people have an enormous contribution to make. Partnering with them, allowing them a meaningful seat at the table can yield fantastic results:

• They can help us understand the behavioral and developmental factors that will affect a vaccine's efficacy.
• They can reach out to their peers to help communities prepare for the advent of a vaccine.
• They can participate on community advisory boards, scientific committees and protocol teams.
• They can participate in clinical trials.

With commitment, foresight, and mutual respect, we can make their participation possible. And it is this participation that will insure that young people are not left behind when an HIV vaccine is found.

This past year, UNAIDS issued a statement declaring that "children, including infants and adolescents, should be eligible for enrollment in HIV preventive vaccine trials, both as a matter of equity and as a function of the fact that in many communities throughout the world they are at high risk of HIV." They further declared that "efforts should be taken to design vaccine development programmes that address the particular ethical and legal considerations relevant for children and teens, and safeguard their rights and welfare during participation."

Advocates for Youth and the AIDS Vaccine Advocacy Coalition believe that young people have the right to expect that they will be among the first able to avail themselves of a safe and effective HIV vaccine. We believe that young people, regardless of race, ethnicity, sexual orientation, or nation of residence have the right to expect to live past the age of 35, to enjoy a safe and healthy adolescence, and as they mature to enter into an intimate relationship free from the fear of HIV.

And so, it is on behalf of, and along with, young people, that Advocates for Youth and the AIDS Vaccine Advocacy Coalition issue this call for action.

We call on The HIV Vaccine Trials Network and all other HIV vaccine research efforts to immediately reach out to young people to include them as part of community advisory boards, scientific committees, and protocol teams.

We call on the National Institutes of Health to immediately identify all barriers to young people's inclusion in current and future HIV vaccine trials and to issue protocols within the next six months to overcome these barriers safely and effectively.

We, as a society, stand at a crossroad. Will we act with vision and foresight to aggressively seek an effective HIV vaccine appropriate for those most at risk of this disease? Or will we continue on the path of least resistance?

In 1997 President Clinton issued a challenge to the scientific community to find an HIV vaccine within ten years. Today, Advocates for Youth and the AIDS Vaccine Advocacy Coalition strengthen that challenge with this call to action.

The first safe and effective HIV vaccine available must be appropriate for young people and all barriers to their inclusion in the scientific and educational process that will make that possible must be overcome immediately. Future generations deserve the opportunity to live in a world without AIDS. Society has a responsibility to make that dream a reality.