About Step Study

The Step Study: An HIV Vaccine Trial

We are looking for an effective and safe vaccine against HIV/AIDS. Each year, more than 4 million people become infected with the HIV virus. A preventive vaccine against HIV offers the best hope in ending this worldwide epidemic. The Step Study is part of an international effort to test and find an HIV vaccine that will work safely in diverse populations.

Finding a safe and effective HIV vaccine that will protect people is a formidable task. We cannot do it without the help of volunteers. Participants in the study will NOT be at risk for HIV infection from the vaccine. A total of 3,000 people will participate in the Step Study. The Step Study is being conducted in the United States, Puerto Rico, Haiti, Dominican Republic, Canada, Australia and Peru.

Safety is the primary goal of the Step Study. This is a Phase II study, designed to yield limited information on the efficacy of the vaccine. The Step Study vaccine has been found to be safe in animals and humans in previous trials. The Step Study vaccine is made from an inactivated cold virus known as an adenovirus. The vaccine does NOT contain the HIV virus, and CANNOT cause HIV infection. Since the vaccine is not yet proven to prevent HIV infection, we urge our volunteers to practice safe sex.

The Science

The scientific name for the Step Study vaccine is Ad5 HIV-1 gag/pol/nef. It is composed of an adenovirus vector and an HIV gene insert.

A vector is used to carry a few non-reproducing HIV genes into the body to create an immune response. In this investigational vaccine, the vector is made from adenovirus type 5 (Ad5), a virus that causes the common cold and sore throats, but the vector has been crippled so that it cannot grow or spread in the body and it cannot cause you to get sick.

A synthetic insert consists of specific genes added to the vector. In this case, the genes added are HIV genes (gag, pol, and nef) which are man-made.

Neither the virus vector nor the HIV genes can cause HIV or AIDS.

Articles on The Step Study

› Genre
› Out
› Science Magazine (2)
› News 8 Austin
› Planetout.com
› Science Magazine (1)
› Seattle Post-Intelligencer
› Financial Times of London
› Seattle Times
› Press Release

The Step Study is a collaboration between the HIV Vaccine Trials Network, the National Institute of Allergy and Infectious Diseases and the vaccine developer, a pharmaceutical company.


	About the Step Study The Step Study: An HIV Vaccine Trial We are looking for an effective and safe vaccine against HIV/AIDS. Each year, more than 4 million people become infected with the HIV virus. A preventive vaccine against HIV offers the best hope in ending this worldwide epidemic. The Step Study is part of an international effort to test and find an HIV vaccine that will work safely in diverse populations. Finding a safe and effective HIV vaccine that will protect people is a formidable task. We cannot do it without the help of volunteers. Participants in the study will NOT be at risk for HIV infection from the vaccine. A total of 3,000 people will participate in the Step Study. The Step Study is being conducted in the United States, Puerto Rico, Haiti, Dominican Republic, Canada, Australia and Peru. Safety is the primary goal of the Step Study. This is a Phase II study, designed to yield limited information on the efficacy of the vaccine. The Step Study vaccine has been found to be safe in animals and humans in previous trials. The Step Study vaccine is made from an inactivated cold virus known as an adenovirus. The vaccine does NOT contain the HIV virus, and CANNOT cause HIV infection. Since the vaccine is not yet proven to prevent HIV infection, we urge our volunteers to practice safe sex. The Science The scientific name for the Step Study vaccine is Ad5 HIV-1 gag/pol/nef. It is composed of an adenovirus vector and an HIV gene insert. A vector is used to carry a few non-reproducing HIV genes into the body to create an immune response. In this investigational vaccine, the vector is made from adenovirus type 5 (Ad5), a virus that causes the common cold and sore throats, but the vector has been crippled so that it cannot grow or spread in the body and it cannot cause you to get sick. A synthetic insert consists of specific genes added to the vector. In this case, the genes added are HIV genes (gag, pol, and nef) which are man-made. Neither the virus vector nor the HIV genes can cause HIV or AIDS. Articles on The Step Study › Genre › Out › Science Magazine (2) › News 8 Austin › Planetout.com › Science Magazine (1) › Seattle Post-Intelligencer › Financial Times of London › Seattle Times › Press Release The Step Study is a collaboration between the HIV Vaccine Trials Network, the National Institute of Allergy and Infectious Diseases and the vaccine developer, a pharmaceutical company.