|HVTN 105 (HIV-negative, 18-50 years old, women, men including Transgender* individuals)
HVTN 105 is the name of a study to test 2 research vaccines. Some people in this study will also get a placebo. A placebo does not contain any
vaccine. Sterile salt water is being used as the placebo for this study. We do not expect it to cause any health problems in people.
The 2 research vaccines used in this study are not produced from live HIV or from HIV infected human cells. These reseach vaccines cannot cause HIV infection.
We are doing this study to answer several questions:
- Are the study vaccines safe to give to people?
- Are people able to take the study vaccines without becoming too uncomfortable?
- How do people’s immune systems respond to the study vaccines? (Your immune system protects you from disease.)
- Does the order in which the study vaccines are given affect the immune responses to the study vaccines?
In addition to giving you the study products, we will:
- Do regular HIV testing, as well as counseling on your results and on how to avoid
- Do physical exams;
- Take blood and urine samples;
- Do pregnancy tests if you were born female; persons who have had a complete
hysterectomy (removal of the uterus and ovaries, verified by medical records), are
not required to have pregnancy tests;
- Ask questions about your health, including medications you may be taking;
- Ask questions about any personal problems or benefits you may have from being in
the study; and
- Ask questions about whether you have had any HIV tests outside the study.
When we take blood, the amount will depend on the lab tests we need to do. It will be an amount between 10 mL and 230 mL (a little less than 1 tablespoon to a little less than 1 cup). Your body will make new blood to replace the blood we take out.
We will be looking for side effects. We will review the results of these procedures and tests with you at your next visit, or sooner if necessary. If any of the results are important to your health, we will tell you. We will also offer you counseling and referral for needed care.
This trial will include 104 volunteers from various US sites and in Seattle, we hope to enroll 10 volunteers who are HIV-negative, healthy, 18 to 50 year-old women, men & Transgender* individuals. Study volunteers will be scheduled for 10 clinic visits over 12 month period.
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).
If you have questions about this study or would like to participate, please call us at 206.667.2300