1. What is a Vaccine? What Is A Vaccine? A vaccine is a substance that teaches the body’s immune system to recognize and protect against a disease caused by an infectious agent (e.g. virus or bacterium).

2. WHY DO WE NEED AN HIV VACCINE? No major viral epidemic has been defeated without a vaccine. Vaccines have significantly reduced the number of illnesses and deaths from diseases such as polio, measles and Hepatitis B. An HIV vaccine is essential in the fight against HIV/AIDS along with other forms of prevention, treatment and care. Why Do We Need An HIV Vaccine?

3. Why Do We Need a Preventive HIV Vaccine? HIV/AIDS continues to claim the lives of too many people - in the last 30 years over 600,000 people with AIDS in the US have died 1. Even a partially-effective AIDS vaccine could save millions of lives. Unlike preventive measures like condoms, an HIV vaccine would not depend on the consent of both sexual partners. Vaccinating large numbers of people would require relatively little equipment and expertise. Source: CDC

4. Impact of HIV among AA and Latinos Gay and bisexual men of all races remain the group most critically affected by HIV. African Americans are most severely burdened by HIV/AIDS. Hispanics/Latinos are also disproportionately impacted by HIV/AIDS. Highly-Impacted Populations in the United States Highly-Impacted Populations in the United States

5. IMPACT OF HIV AMONG MSM In 2006, Gay/bisexual men (or men who have sex with men, MSM) accounted for more than half (53%) of all new infections in the United States as well as about half of people living with HIV. Impact of HIV/AIDS: Gay and Bisexual Men Impact of HIV/AIDS: Gay and Bisexual Men New HIV infections among gay/bisexual men have been increasing since 1990. Since the beginning of the epidemic, over 300,000 MSMs with AIDS have died.

6. IMPACT OF HIV AMONG MSM At some point in their lifetime, one in 16 black men will be diagnosed with HIV, as will one in 30 black women. In 2009, blacks accounted for more than half (52%) of new HIV diagnoses. In 2006, the rate of HIV infection for black men was 6 times as high as that of white men, nearly three times that of Hispanic/Latino men and twice that of black women. In 2006, HIV was the ninth leading cause of death for all African Americans. Impact of HIV/AIDS: African Americans Impact of HIV/AIDS: African Americans

7. IMPACT OF HIV AMONG MSM Impact of HIV/AIDS: Hispanics and Latinos Impact of HIV/AIDS: Hispanics and Latinos While Hispanics/Latinos only represented approximately 15% of the United States population in 2006, they accounted for 17% of new HIV infections in the US that year. One in 36 Hispanic/Latino men will be diagnosed with HIV at some point in their lifetime, as will 1 in 106 Hispanic/ Latina women. In 2008, an estimated 7,864 Hispanics/Latinos were diagnosed with AIDS in the U.S.

8. Black gay and bisexual men are disproportionately impacted by HIV/AIDS in the U.S. Impact among Black gay men Impact of HIV/AIDS Black Gay and Bisexual Men Impact of HIV/AIDS Black Gay and Bisexual Men Most new infections among black gay/bisexual men occur among young black gay/bisexual men. There are more new HIV infections among young, black gay/bisexual men (aged 13–29) than among any other age and racial group of gay/bisexual men Source: CDC, 2010

9. Why do we think an HIV vaccine may be possible? Results from the AIDS vaccine trial RV144 in Thailand were the first ever to show modest efficacy in preventing transmission of HIV. There were about 31 percent fewer infections among participants who received the vaccine compared with those who received the placebo. Neutralizing antibodies can prevent infection by SIV, the monkey version of HIV. An HIV Vaccine Is Possible

10. Why do we think an HIV vaccine may be possible? Some people’s immune systems can naturally control the virus for years, sometimes decades. Vaccines can protect monkeys from SIV infection or significantly delay disease. An HIV Vaccine Is Possible

11. Why do we think an HIV vaccine may be possible? Vaccine Success Stories Viral Disease Year of Peak US Prevalence Peak Number of Cases per Year in US Number of Annual US Cases in Modern Vaccine Era (2007) Diphtheria1921200,0000 Hepatitis A197159,6062,979 Hepatitis B198526,6544,519 Measles1958 – 1962503,28243 Mumps1967185,691800 Pertussis1934265,26910,454 Polio1951 – 195416,3160 Rubella1966 – 196847,74512 Smallpox1900 – 190448,1640

12. Success Takes Time DiseaseYears to develop vaccine Typhoid105 Haemophilus influenzae92 Pertussis89 Polio47 Measles42 Rotavirus33 Human Papillomavirus23 Hepatitis B15 Herpes 45 + ? HIV 25 + ?

13. DISCOVERY VACCINE DESIGN PRECLINICAL RESEARCH CLINICAL TRIALS How Is A Vaccine Developed?

14. HVTN 505 For up-to-date information on the HVTN 505 study, refer to the HIV Vaccine Trials Network site at http://www.hvtn.org

15. Why Human Volunteers are Needed To gather the best data about vaccine safety and effectiveness, preventive HIV vaccines are tested among individuals from diverse backgrounds. Participants come from different: – Sexes – Races/Ethnicities – Socioeconomic backgrounds – Potential routes of transmission – Environmental backgrounds

16. Today’s research studies have safeguards in place to protect the safety and well-being of participants. In the U.S., several organizations are responsible for vaccine research ethics: o Institutional Review Boards o Office of Human Research Protection o U.S. Food & Drug Administration (FDA) All participants in HVTN trials have a Bill of Rights and Responsibilities The Safety of the Volunteers is Important

17. I will get HIV from the vaccine being tested. FALSE The vaccines being tested do not contain live HIV, killed HIV, weakened HIV, or HIV-infected cells. Instead, scientists use individual HIV genes or proteins that trick the body in order to stimulate an immune response. Myths about HIV and HIV Vaccine Research

18. There is already an HIV vaccine. FALSE No vaccine has yet been proven effective enough for widespread use, but scientists are working on a number of approaches. Myths about HIV and HIV Vaccine Research

19. Magic Johnson is cured of AIDS, so I don’t have to worry about getting infected. FALSE Magic Johnson is, to this day, still living with HIV. He keeps his infection under control with the help of his health care providers and his prescribed medications, just like millions of people living with HIV around the world. Myths about HIV and HIV Vaccine Research

20. You have to have HIV to volunteer in a preventive HIV vaccine trial. FALSE All volunteers in preventive HIV vaccine trials are HIV-negative. In order to test whether an HIV vaccine actually works, all participants must be HIV- negative when they initially enroll in the trial. Depending on the trial, participants may need to be at low- or high-risk of HIV based on their behavior and demographics Myths about HIV and HIV Vaccine Research

21. Educate yourself and others about HIV vaccine research – visit http://www.bethegeneration.nih.gov. Talk to a friend or family member about HIV vaccine research. Talk about HIV prevention. Find out if you are a good candidate for an HIV/AIDS vaccine trial. Support trial volunteers. Visit www.hvtn.org to locate your community vaccine trial site and participate in a Community Advisory Board.www.hvtn.org YOU can help in the search for an HIV vaccine!

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