| 1. Can I get HIV/AIDS from the investigational vaccine? |
No.
You cannot get an HIV infection from the vaccine. In
this investigational vaccine, scientists created synthetic
(man-made) genes. These synthetic genes are designed
to make proteins that resemble those present in a real
virus. They do not contain the information required
to cause HIV infection. Proteins in the vaccine are
present for a short time before being broken down by
the body. These proteins are look-alikes, are not live,
so they cannot cause HIV. There is no virus or infected
material in the investigational vaccine, so there is
no way that it can cause HIV/AIDS. |
| 2. How does this investigational HIV vaccine work? |
The vaccine is designed to work by mimicking the shapes and structures of HIV proteins. They cause the immune system to produce antibodies and lymphocyte responses that may recognize and attack HIV. In this way the immune system may be educated to recognize and potentially respond quickly if you were to encounter HIV. The hope is that the body's natural immunity prepared by vaccination will be able to fight off a real HIV exposure. Please remember that this is an investigational vaccine. We don't know if it works and extensive testing will be needed to eventually answer this question. |
| 3. How can I find out if I'm eligible for the study? |
Please call the Vaccine Research Center (VRC) toll-free
at 1-866 833-LIFE (5433) or email us at VRCForLife@mail.nih.gov. We are looking for healthy HIV
negative volunteers between the ages of 18-50. When you contact our staff, you will have a brief phone conversation. If you meet
certain criteria, a screening visit will be arranged. At this visit a complete physical examination and blood work will be done
to determine if you are eligible.
|
| 4. How long is the study, and how much time will I have to commit? |
| Depending on the study, most VRC trials have 7-14 visits over a period of 6 to 12 months and include 1 to 4 injections. Screening and vaccination visits can take up to 4 hours. All other visits are under an hour. |
| 5. Where and when can I go for appointments? |
| Study visits are conducted on the Bethesda campus of the National Institutes of Health (NIH) Clinical Center in the Vaccine Research Center (VRC). Free valet parking is available. We are Metro accessible via the Red Line, at the Medical Center Station. Regular clinic hours are Monday through Friday from 8:00 AM to 4:30 PM. We can usually schedule clinic visits at other times to meet individual needs; however we cannot conduct visits on holidays or weekends. |
| 6. What if I move out of town? |
| If you move out of the area within the first few months of starting a study, we may not be able to monitor you adequately. When you contact a VRC staff member, please discuss with us any relocation or extended travel plans. |
| 7. Will I be paid for my participation? |
| You will be reimbursed for your visits to the VRC. We offer about $100 for vaccination visits, and $50.00-$70.00 for other visits. |
| 8. What if I test "false-positive" for HIV? |
| To be eligible for a study you must be HIV negative. Some investigational vaccines may be strong enough to cause an antibody response detectable on standard HIV tests. These tests measure the body's antibody response to HIV, and do not directly measure HIV itself. Therefore, having a false-positive antibody test for HIV after vaccination is not unexpected. It does not mean you are infected. At every visit, we perform specialized testing to prove that you are not HIV infected. No medical side effects or problems are associated with having a false-positive antibody test. Remember, this vaccine contains no live virus, so you cannot be infected with HIV or develop AIDS from this vaccine. |
| 9. Can I donate blood during or after the study? |
| You
cannot donate blood, blood products such as platelets,
or bone marrow during the study. In addition, blood banks
will not accept donations for one year after the last
dose of an investigational vaccine. Also, please do not
donate blood six weeks before starting a study because
we cannot draw blood required for screening. |
| 10. What side effects can I expect from the investigational vaccine? |
| You might have short-term side effects similar to those from any vaccination such as arm soreness. Since this vaccine has not been given to people, there may be risks or side effects that are not known. Prior to the study, a medical provider will describe all possible side effects with you, even those that are theoretical. |
| 11. Will this vaccine protect me from HIV? |
| No. There is no evidence that this investigational vaccine will protect you from getting HIV infection. The main purpose of this study is to test whether the investigational vaccine is safe. You should avoid high-risk behavior that would put you at risk for HIV infection. |
| 12. Will the vaccine cause me to transmit HIV? |
| No. This vaccine is not made from live virus or HIV infected cells. There is no possibility that it contains live or killed HIV; therefore, it is impossible to be infected with HIV or develop AIDS from the vaccine. |
| 13. How will you know if this vaccine works? |
| Certain times after receiving each injection, specialized laboratory testing will be done on your blood to see if your immune system responds to the vaccine. The results of these tests will be evaluated and compared to what we have learned about vaccine-induced protective responses in animal studies. We will not expose you to the virus at any time and ask that you avoid any risk that may cause you to be exposed to the virus. Specific counseling will be available to help you stay HIV uninfected during the trial. This vaccine is part of a global effort to create a safe, effective vaccine for HIV. After trials are completed at this site, our vaccine will be placed into expanded clinical trials in the United States and around the world. Eventually large trials will be done to see if the vaccine can reduce the rate of HIV infection. |
If you have a question about a particular VRC clinical trial,
and it isn't answered here or elsewhere on our website, please
contact us via e-mail at VRCforlife@mail.nih.gov
or call 1-866-833-LIFE (5433).
