This is a phase II study that is testing two types of experimental preventive HIV vaccines. The study vaccines are called pGA2/JS7 DNA and MVA/HIV62. From here on, we will call them the DNA vaccine and the MVA vaccine, or the “study vaccines.” They are experimental preventive HIV vaccines.

DNA vaccine
DNA is a natural substance found in all living things, including people and viruses. DNA instructs cells to make proteins. In this study, the DNA vaccine will tell your body to make a small amount of some proteins that are found in HIV. Your body’s immune system might recognize these proteins and prepare itself to fight HIV. This is called an immune response. The DNA vaccine is similar to natural DNA, but it was made in a laboratory. You cannot become infected with HIV or AIDS from the DNA vaccine or from these proteins.

MVA vaccine
The MVA vaccine was made from a virus called Modified Vaccinia Ankara virus, which was developed to protect against smallpox. The virus in the vaccine has been changed so that it will not spread in your body. It also will not be contagious to people around you. The MVA vaccine will instruct the body to make a few of the same proteins as the DNA vaccine, proteins that are found in HIV. These proteins may cause the body to have an immune response.

The study vaccines have been given to people before. HVTN 065, the first study of these vaccines in people, involved 120 participants. These people received the DNA vaccine and the MVA vaccine, or just the MVA vaccine, or sterile salt water without the vaccines. In that study, the DNA and MVA vaccines did not cause safety problems and were well tolerated.

Based on the safety results and immune responses seen in HVTN 065, researchers feel it is appropriate to continue studying these products in a larger group of people. In Seattle, we hope to enroll 20-24, hiv-negative, healthy volunteers.

HVTN 205 FAQs: download pdf here

This is a phase I study that is testing various injection methods for giving the vaccines. In this study they will be using two different study vaccines (and no placebos) that have been given to more than 100 people in studies before. People eligible for this study, will be assigned to one of three groups. People in all groups will get three injections of the study vaccines into the muscle of their arm. People in Group 1 will get an injection into the muscle in their arm. People in Group 2 will get an injection between the layers of their skin of their arm. People in Group 3 will get an injection under their skin of their arm. All three ways of giving the injection have been used for giving other vaccines. Participants are assigned to a group at random, like the toss of a coin. They have a 1-in-3 chance of being in any one of the groups. Participants and the researchers will know which group they are in. To date, the vaccines have been well tolerated with only a few expected side effects. The vaccines do not contain live or killed HIV, so there is NO possibility of getting HIV from them. A total of about 90 people will take part at all participating sites. Enrollment for this study is complete.

This phase II study will be testing the same product used in the Step Study(see below). This vaccine has been tested in over 1300 people in the United States as well as over 700 people outside of the United States. To date, the vaccine has been generally well-tolerated. The vaccine has also been tested in animals with no serious side effects. The vaccine is made in a laboratory. The purpose of this study is to test various dosages. This study will not use a placebo because it has been used in other studies. This study will be 9 months long and requires volunteers to be vaccinated at 3 different visits. This study enrolled volunteers who were at low risk of getting HIV. There will be a total of about 204 people in this study.  Enrollment for this study is complete.

Merck & Co., Inc. and the HIV Vaccine Trials Network announce that vaccination is being discontinued in the Step Study. The investigational vaccine has been found to be not effective. Click here to learn more.

This protocol is a Phase Ib open-label study that has the same vaccine that was used in the Step Study (Merck Ad-5 vaccine). Open label means that everyone in this study received the vaccine. There was no placebo. Volunteers received vaccine at day 0, month 1 and month 6. There were 35 nationwide enrolled and 11 were enrolled at the Seattle site. This study was intended to better understand the immune responses to this vaccine and also evaluate immune responses in cervical secretions and semen samples among willing volunteers. Volunteers were also asked to have a leukapheresis done at 2 time points during the study. This is a procedure done at the Puget Sound Blood Center. Blood is taken from the body, a large volume of white blood cells are removed, and all other components of the blood are returned to the volunteer. This provides the study laboratory scientists with millions of white blood cells to use for immunological tests. Volunteers are coming up on their final study visits.