What is HIV?
HIV (human immunodeficiency virus) is the name of the virus that causes AIDS. Scientists have identified the virus as a "retrovirus," which is a virus in a very specific family of viruses. This virus is passed from one person to another through blood-to-blood and sexual contact. In addition, infected pregnant women can pass HIV to their babies during pregnancy, delivery, or breast-feeding.

How is HIV contracted?
HIV is transmitted through the passage of body fluids from an infected person to an uninfected person.

• Blood (such as sharing needles with an injection
• drug user who is HIV infected)
• Semen
• Vaginal fluid
• Breast milk
• Other body fluids containing blood

How is HIV infection prevented?

• Safer sex (male and female condoms)
• Clean needle use
• Abstinence
• Use of HIV medications during pregnancy
• Avoidance of breast feeding by HIV infected mothers

Why we need new HIV prevention tools?
Despite the fact that we know how to prevent HIV, infections rates continue to increase. What are some reasons for increasing HIV infections despite known methods of prevention? Why donât we always use condoms or clean needles? (IF LEADING A DISCUSSION, ASK FOR RESPONSES FROM AUDIENCE.)

• Desire for pregnancy
• Desire for intimacy
• Forced intimacy
• Faith-based opposition to condoms
• Lack of a clean needle
• Etc·

We need alternative HIV prevention methods that will address some of the gaps in safer sex and injection drug use behavior. One new method under research is an HIV vaccine. A vaccine offers our best hope for ending the HIV pandemic.

What is a vaccine?
Vaccines introduce into the body an element Ð natural or engineered Ð of a disease. The element causes the immune system Ð which is the bodyâs disease fighting mechanism Ð to develop an antibody. Antibodies are the soldiers of the immune system, which fight off any foreign or unwanted bodies. Antibodies stay in your body and maintain the ability to recognize virus elements so that if later on the virus tries to enter, the antibodies stored in the body will go to war against the invading virus cells.

Vaccines have been used for decades around the world, most commonly in children. They are very safe when manufactured and used properly and are very cost-effective compared to treatment. 16 vaccines are now used in the United States. Vaccines have eliminated smallpox worldwide, soon polio.

How do HIV vaccines work?

• HIV vaccines are designed to stimulate the immune system to produce antibodies (cells that kill virus found free-floating in the blood) and/or cytotoxic lymphocytes (CTLs or "killer T cells" that destroy HIV infected cells).
• Vaccinated persons may test HIV positive on standard ELISA test due to HIV antibody presence. Western Blot test can distinguish if person is HIV positive due to vaccine-induced antibody or if person is truly HIV infected due to standard HIV transmission routes.
• HIV vaccines are being studied to see if they can prevent infection or diminish disease progression post infection.
• HIV vaccines under study do no contain real HIV and therefore cannot cause HIV infection.
  

How are HIV vaccines tested?
Potential vaccine products are first tested in the laboratory and in animal models. If these tests show that the vaccine appears to be safe and shows some ability to protect against HIV, the next step is to try the substances in humans.

Human subject trials proceed through 4 phases:

• Phase I -- few participants, safety is main objective
• Phase II -- more participants, safety and immune response are measured
• Phase III -- hundreds to thousands of participants, safety and effectiveness in HIV prevention are assessed
• Phase IV -- thousands to tens of thousands of participants, post FDA approval, safety and effectiveness in widespread use.
  

Status of HIV vaccine research
Numerous phase I trials and a handful of phase II trials have been conducted with potential HIV vaccine products. The first-ever phase III trial of a vaccine product concluded in December 2002. The vaccine tested was not shown to be effective in preventing HIV infection.

Would a vaccine eliminate the need for condoms?
No. When used consistently and correctly, condoms are likely to provide better protection against HIV and STDs, so they will still be the preferred option. But for people who cannot or will not use a condom, or for whom, use of a clean needle is not always realistic, a vaccine can save lives and have a substantial impact on the epidemic.

Community issues
Vaccine trials need community members to enroll. These trial volunteers need initial and on-going education to understand vaccine research and the particulars about the trial they are joining.

A particularly sensitive issue for volunteers is the possibility of testing HIV antibody positive due to the immune systemâs response to vaccination. Volunteers may experience social harms from immigration, incarceration, military, health/life insurance services and social stigmatization. Study staff are trained and are ethically bound to provide thorough education and supportive services to verify vaccine positive results versus positive results from true HIV infection.

Beyond study staff, trial volunteers need knowledgeable community advisors and representatives. Community leaders/representatives are needed to learn about vaccine research and to reach out within their community to educate others.

Finally, community activists are needed to continue to safeguard the interests of trial volunteers and to advocate for funding to conduct vaccine research. An effective vaccine could be identified within 10 years with adequate funding and well implemented clinical trials.

Questions for audience
How best do we reach at-risk communities regarding HIV vaccine research?
How do we overcome distrust of the medical community and vaccines in adults?