At A Glance - NIAID HIV/AIDS Vaccine Research

FY 1999 Expenditures	$136.3 million NIAID ($181.7 million NIH)
FY 2000 Estimate	$181.8 million NIAID ($238.7 million NIH)
FY 2001 Estimate	$204.7 million NIAID ($267.5 million NIH)

The Disease

Acquired immune deficiency syndrome (AIDS) is caused by the human immunodeficiency virus (HIV). Infection with the virus leads to destruction of a person's immune system, making the victim highly susceptible to multiple infections and certain cancers. AIDS is a fatal disorder, and a vaccine is not available.

Worldwide Incidence

• About 5 young people become infected with HIV every minute
• More than 16 million people have died from AIDS, including 3.2 million children
• Ninety-five percent of worldwide AIDS cases occur in developing countries, with nearly 70 percent of all cases occurring in sub-Saharan Africa
• Over 80 percent of global HIV infections result from heterosexual intercourse
• Mother-to-child (vertical) transmission has accounted for more than 90 percent of all HIV infections worldwide in infants and children

United States Incidence

• Between 650,000 and 900,000 people in the United States are living with HIV infection
• Of new infections among men in the United States, CDC estimates that 60 percent of men were infected through sex with other men, 25 percent through injection drug use, and 15 percent through sex with women. Of newly infected men, 50 percent are black, 30 percent are white, 20 percent are Latino, and a small percentage are members of other racial or ethnic groups.
• Of new infections among women in the United States, CDC estimates that 75 percent of women were infected through sex with men and 25 percent through injection drug use. Of newly infected women, 64 percent are black, 18 percent are white, 18 percent are Latino, and a small percentage are members of other racial or ethnic groups.
• AIDS deaths have been declining in the United States since 1996

NIAID's Strategy to Identify a Safe and Effective HIV Vaccine

• Maintain a program of scientific inquiry that integrates fundamental research and empiric development to advance a broad front of critical knowledge and a variety of vaccine designs through laboratory, animal, and human research
• Develop more and better-defined partnerships between NIAID and industry sponsors of vaccine development
• Identify and exploit scientific opportunities to accelerate HIV vaccine research
• Strengthen linkages with communities and other public or private organizations working in the field

Recent Accomplishments and Developments

• The first human trial of a candidate vaccine in Africa was launched in 1999; preliminary results will be available in summer 2000
• Since 1987, NIAID has enrolled over 3,357 volunteers in 53 Phase I & Phase II preventive HIV vaccine trials of 28 candidate vaccines
• The candidate vaccines evaluated to date appear safe
• Major components of NIAID's vaccine efforts include
• AIDS Vaccine Innovation Grants
• HIV Vaccine Research & Design Program
• Integrated Preclinical/Clinical AIDS Vaccine Development Program
• HIV Vaccine Trials Network
• HIV Prevention Trials Network
• NIH Dale & Betty Bumpers Vaccine Research Center (with NCI)
• Animal studies have shown for the first time that it is possible to have a single HIV protein elicit a broad immune response against multiple types of HIV; efforts are underway to make a more practical design for use in people
• Preclinical research has shown that vaccines consisting of inactivated, HIV-like monkey viruses can cause AIDS in infant and adult macaques, even when these viruses are missing major portions of their DNA
• Revealed more about the immune response associated with HIV infection, opening new avenues for vaccine design
• Candidate vaccines using different proteins from HIV, different delivery vectors, and different immunization protocols produced durable T cell and antibody responses against HIV
• Two new networks are being established: the HIV Vaccine Trials Network (HVTN) and a dedicated HIV Prevention Trials Network (HPTN). The goal of these networks is to create stronger, investigator-led, cooperative clinical trials networks that are optimally focused and designed to address scientific and public health needs both in the United States and internationally. The HPTN will be cosponsored by the National Institute of Mental Health, the National Institute of Child Health and Human Development, and the National Institute of Drug Abuse

Future Plans

• Expand the HVTN to initiate vaccine efficacy trials
• Expand the HPTN to initiate prevention efficacy trials