HVTN 505 is the name of a clinical trial that tests a combination of 2 experimental HIV vaccines. Scientists think that this study regimen may provide insight into how to make future HIV vaccine products.

The products used in this trial are not produced from live HIV or from HIV infected human cells. These study vaccines cannot cause HIV infection

We are doing this study to answer several questions:

Does the group that gets the study vaccines have a lower chance of HIV infection than the group that gets the placebos?

Can the study vaccines reduce the level of HIV in the blood of people who become infected with HIV?

Are the study vaccines safe to give to people?

The study vaccines have been given to people before.The vaccines used in this trial have been given to hundreds of people in previous clinical trials over the past five years without serious side effects.

This trial will include 2200 participants from various US sites: half of the participants will receive the study vaccines and half of participants will receive a placebo, which is a solution that does not contain the vaccines. In Seattle, we hope to enroll 180, hiv-negative, healthy men who have sex with men (MSM) or transgender women. They must be 18-50 years old and they must be circumcised. Study volunteers will be scheduled for clinic visits for about 2 years, followed by annual contacts for 3 more years after enrollment.

Several groups watch over this study to see that we are protecting volunteer rights, keeping volunteers safe, and following the study plan.

These groups include:

The Seattle HIV Vaccine Trials Unit Community Advisory Board;

The US NIH and its study monitors,

The US Food and Drug Administration (FDA),

The Fred Hutchinson Cancer Research Center,

The Vaccine Research Center, which is part of the US National Institutes of Health.,

The HIV Vaccine Trials Network (HVTN),

The HVTN Safety Monitoring Board (SMB),

The US Office for Human Research Protections (OHRP).

HVTN 505 FAQs: download pdf here

If you have questions about this study or would like to participate, please call us at 206.667.2300

About 45 people will take part in this study in Seattle.

We are doing this study to answer several questions:

How do people’s immune systems respond to the study vaccines? (Your immune system protects you from disease.) We especially want to know how the immune system responds in certain tissues of the genital tract and rectum. This tissue is called mucosal tissue.

Are the study vaccines safe to give to people?

Are people able to take the study vaccines without becoming too uncomfortable?

The study vaccines cannot give you HIV.

The study vaccines are not made from live HIV or from HIV-infected cells. The study vaccines are man-made. They do not contain live or killed HIV. It is impossible to get HIV from the study vaccines. Also, they cannot cause you to give HIV to someone else.

We do not expect the study vaccines to prevent HIV infection.

Because of this, we counsel volunteers to help them learn how to avoid getting HIV and not do things that can expose them to HIV, like having unprotected sex or sharing needles or injection equipment.

These study vaccines are used only in research studies.

The US Food and Drug Administration (FDA) has not approved the study vaccines for any other use. They are experimental phase of research. This means that they have not been approved for treating or preventing HIV infection. The US FDA allows their use in research only.

Several groups watch over this study to see that we are protecting volunteer rights, keeping volunteers safe, and following the study plan.
These groups include:

The Seattle HIV Vaccine Trials Unit Community Advisory Board;

The US NIH and its study monitors,

The US Food and Drug Administration (FDA),

The Fred Hutchinson Cancer Research Center,

The Vaccine Research Center (VRC),

The HIV Vaccine Trials Network (HVTN),

The HVTN Safety Monitoring Board (SMB),

The US Office for Human Research Protections (OHRP).

HVTN 076 FAQs: download pdf here

If you have questions about this study or would like to participate, please call us at 206.667.2300

People in the HVTN 910 study will not be getting any experimental vaccines or treatments. They will only have blood tests.

The body makes antibodies naturally to fight germs after it is exposed to them. The antibodies attack germs and keep them from infecting the body’s cells. Most vaccines help prevent disease by telling the body to make antibodies. Most commonly available tests for HIV only look for antibodies. If a person is making antibodies to HIV because of the vaccine(s) he or she received, some tests could come back positive even if the person is not infected with the virus. This is called a VISP (vaccine-induced seropositive) test result. You may also see this called a "false positive" test result.

The HIV Vaccine Trials Network (HVTN) has tests that tell the difference between VISP test results and real HIV infection. We can also tell volunteers when they no longer test VISP. If this happens on several tests in a row, they may no longer need the specific testing the HVTN offers.

People participating in HVTN 910 can stay in the study as long as they need testing that can tell the difference between VISP test results and real HIV infection.

We are doing this study to answer several reasons:

• To help our volunteers with problems caused by VISP test results;

• To find out how long HIV vaccines cause VISP results on common HIV tests;

• To find out if VISP results are always the same, or if they switch between positive and negative on repeated tests; and

• To help provide information for new HIV tests that may become available in the future.

For more information on VISP, please visit: www.hvtn.org/visp

If you were in an HVTN HIV vaccine study yesterday or years ago, it's never to late to be a part of HVTN 910, please call us at 206.667.2300

Twins can help us make unique discoveries in our search to find an HIV vaccine. As researchers work to develop vaccines for various illnesses, information about why people react differently to vaccines, based on their genes or their environmental exposures, could be helpful to move their knowledge forward.

HVTN 082 is looking at immune responses to different combinations of 2 experimental HIV vaccines. The products used in this study are not produced from live HIV or from HIV infected human cells. These study vaccines cannot cause HIV infection The main purpose of the study is to learn more about how a person’s genetic makeup shapes the way the immune system responds to vaccination. We know that a person’s genes, passed down from his or her mother and father, may influence how a person might react to HIV vaccines. However, we do not know what this influence may look like. We are hoping to better understand the role of genetics by looking at the immune responses of twins to the HIV vaccines in this study. Knowing the answer to this question could help researchers design vaccines with greater potential to help fight HIV. The study vaccines have been given to people before. In the past study of these vaccines, people were able to take the vaccines without too much discomfort and only minor reactions. Vaccines similar to these study vaccines have been given to hundreds of people in earlier studies without serious side effects. Each participant's health and safety will be wathced closely throughout the study. The trial will involves twin pairs from Seattle, Boston and San Francisco.

HVTN 082 FAQs: download pdf here.

If you have questions about this study, please call us at 206.667.2300

About 40 people are in this study. They were divided into 2 groups. Group 1 has 20 people who got a study vaccine in an earlier HIV vaccine study and Group 2 has about 20 people who did not. This study will be done in Seattle and other sites in the US.

We are doing this study to answer several questions.

• Is the study vaccine safe to give to people?

• Are people able to take the study vaccine without becoming too uncomfortable?

• How do people’s immune systems respond to the study vaccine? (Your immune system protects you from disease.)

• Is there a difference in the immune response between the two groups?

The study vaccine was developed by Novartis Vaccines and Diagnostics, Inc. The study vaccine is made out of man-made proteins which are similar to proteins from the outer surface of HIV. Your body’s immune system may respond to this study vaccine by making cells and antibodies that recognize and fight against HIV proteins. Antibodies are special proteins made by the body that can recognize and prevent infections. Sometimes the body responds better when the vaccine is combined with another substance that helps to alert the immune system. These substances are called adjuvants. The study vaccine includes an experimental adjuvant.

The study vaccine has not been given to people before. It has been tested in mice, rabbits, and monkeys and it did not cause any health concerns. Even if something looks like it is safe or works in animals, that may not be true for people.

The study vaccines cannot give you HIV.

The study vaccines are not made from live HIV or from HIV-infected cells. The study vaccines are man-made. They do not contain live or killed HIV. It is impossible to get HIV from the study vaccines. Also, they cannot cause you to give HIV to someone else.

We do not expect the study vaccines to prevent HIV infection.

Because of this, we counsel volunteers to help them learn how to avoid getting HIV and not do things that can expose them to HIV, like having unprotected sex or sharing needles or injection equipment.

These study vaccines are used only in research studies.

The US Food and Drug Administration (FDA) has not approved the study vaccines for any other use. They are experimental phase of research. This means that they have not been approved for treating or preventing HIV infection. The US FDA allows their use in research only.

Several groups watch over this study to see that we are protecting volunteer rights, keeping volunteers safe, and following the study plan.
These groups include:

• The Seattle HIV Vaccine Trials Unit Community Advisory Board,

• The US NIH and its study monitors,

• he US Food and Drug Administration (FDA),

• The Fred Hutchinson Cancer Research Center ,

• The HIV Vaccine Trials Network (HVTN),

• The HVTN Safety Monitoring Board (SMB),

• The US Office for Human Research Protections (OHRP).

HVTN 088 FAQs: download pdf here

If you have questions about this study, please call us at 206.667.2300