What is a Vaccine?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).

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?Why Do We Need An HIV Vaccine?

Why Do We Need a Preventive HIV Vaccine?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 died1.

• 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

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

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 MenImpact 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.

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

IMPACT OF HIV AMONG MSMImpact of HIV/AIDS:

Hispanics and LatinosImpact 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.

• Black gay and bisexual men are disproportionately impacted by HIV/AIDS in the U.S.

Impact among Black gay menImpact of HIV/AIDS

Black Gay and Bisexual MenImpact 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

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 PossibleAn HIV Vaccine Is Possible

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 PossibleAn HIV Vaccine Is Possible

Why do we think an HIV vaccine may be possible?

Vaccine Success StoriesVaccine Success Stories

Viral DiseaseYear of Peak US

PrevalencePeak Number of Cases

per Year in US

Number of Annual US Cases in Modern

Vaccine Era (2007)

Diphtheria 1921 200,000 0

Hepatitis A 1971 59,606 2,979

Hepatitis B 1985 26,654 4,519

Measles 1958 – 1962 503,282 43

Mumps 1967 185,691 800

Pertussis 1934 265,269 10,454

Polio 1951 – 1954 16,316 0

Rubella 1966 – 1968 47,745 12

Smallpox 1900 – 1904 48,164 0

Success Takes TimeSuccess Takes Time

Disease Years to develop vaccine

Typhoid 105

Haemophilus influenzae 92

Pertussis 89

Polio 47

Measles 42

Rotavirus 33

Human Papillomavirus 23

Hepatitis B 15

Herpes 45 + ?

HIV 25 + ?

DISCOVERYVACCINE DESIGN

PRECLINICAL RESEARCH CLINICAL TRIALS

How Is A Vaccine Developed?How Is A Vaccine Developed?

HVTN 505 HVTN 505

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

Why Human Volunteers are NeededWhy 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

•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 Boardso Office of Human Research Protectiono 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 The Safety of the Volunteers is Important

I will get HIV from the vaccine being tested.

FALSEThe 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 ResearchMyths about HIV and HIV Vaccine Research

There is already an HIV vaccine.

FALSENo 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 ResearchMyths about HIV and HIV Vaccine Research

Magic Johnson is cured of AIDS, so I don’t have to worry about getting infected.

FALSEMagic 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 ResearchMyths about HIV and HIV Vaccine Research

You have to have HIV to volunteer in a preventive HIV vaccine trial.

FALSEAll 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 ResearchMyths about HIV and HIV Vaccine Research

• 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.

YOU can help in the search for an HIV vaccine!

YOU can help in the search for an HIV vaccine!

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