Can I get HIV from the study vaccine?
No. There is no way to contract HIV or AIDS from the vaccine. Because the vaccines are man-made, there is no HIV in the vaccine (either living or dead). You can only get HIV from unsafe sex with an HIV infected partner or sharing needles with someone who is HIV-infected.
Is this study vaccine safe?
The study vaccine has been tested in more than 600 people with few side effects. While scientists believe that there are no serious safety risks with the study vaccine, there is always the possibility that there could be problems that no one expected. This is why this study vaccine, like any new drug or vaccine, needs to be tested in participants in a controlled clinical setting. Participants' health and safety will be closely monitored throughout the trial.
Because the investigational vaccine does not contain the HIV virus, there is no way for the study vaccine to cause HIV infection.
Will the vaccine protect me against HIV?
No. The study vaccine is testing to see if it can reduce the amount of HIV virus in the body in people who become positive during the study. A vaccine that can reduce the amount of virus in the body could potentially lead to reduced infectiousness as well as a better immune response in people who become infected.
Remember that we still do not know if this study vaccine will work in reducing the amount of virus in the body. It is important for study volunteers to practice safe sex and to not share needles. Study participants are counseled at every clinic visit to avoid behavior that will put them at risk of HIV infection.
Will I test HIV-positive as a result of the vaccine?
Study volunteers could have what’s called a false-positive test result if they test outside the research clinic. Study volunteers are asked to ONLY test at the research clinic so we can ensure an accurate test result. Remember, there is no possible way that anyone can contract HIV or AIDS from the vaccine. You can only get HIV from unsafe sex or sharing needles with someone who’s infected.
How do I join the trial?
If you are an HIV-negative male, have sex with men, and live in the Greater Los Angeles area, you may be eligible to participate in this study. Please contact our clinic at (310) 358 2429 or email for more eligibility information.
If you live outside the Los Angeles area, there are other vaccine research sites throughout the US. Please visit http://www.hopetakesaction.org/locations/index.html for a full list.
AIDS Research Alliance supports cultural, ethnic, gender and sexual orientation diversity in research. Different people may respond differently to a vaccine and we need to make sure we find an HIV vaccine that will work well for everybody. While this study has a narrow focus (men who have sex with men), future vaccine studies will likely include women and men who have sex with women. To find other studies you may be eligible to join, visit http://aidsresearch.org/clinical_trials/currentclinicaltrials.html or www.clinicaltrials.gov.
What happens during the study?
After important study information has been fully explained, potential study volunteers are asked to sign an informed consent form. Those providing consent can then be screened to see if they are eligible to join the study. Screening includes blood tests, a physical exam, a questionnaire and an HIV test. Eligible study volunteers who join the study will visit the clinic every three months for an estimated 18 months for checkups, blood draws, and HIV risk reduction counseling and testing. Eligible volunteers will also be vaccinated 4 times during the study (either with the study vaccine or a placebo).
During the trial, clinic staff will monitor participants to make sure the study vaccine is not causing problems. Throughout the trial, any new information researchers learn about the safety of the study vaccine will be given to participants. Participants are reminded frequently that being part of a vaccine trial does not mean they are protected from HIV infection. They are counseled at each clinic visit on ways to avoid HIV infection (for example, correct and consistent condom use).
Why are you only studying circumcised men?
A previous HIV vaccine study found that men who were uncircumcised and received the vaccine appeared to be at greater risk of HIV infection when they had unprotected sex or shared needles. Those who were circumcised did not experience the same risk. As safety is our number one concern, we are only including circumcised men in this study in light of this. Scientists are still trying to better understand why circumcision mattered in this previous study, and we will update this section when more is known.
Does everyone get the HIV vaccine in the study?
No. People are randomly given either the study vaccine or a placebo. Neither you nor the onsite research staff will know whether you received a vaccine or a placebo until the end of the study. This is called a "double blind" study design and guarantees that all participants are studied and followed in exactly the same way.
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How will the safety and rights of participants be protected?
The safety and rights of participants are given the highest priority. This trial meets international standards for ethical research that were created by the Helsinki Declaration of the World Medical Association and Council for International Organizations of Medical Sciences (CIOMS) guidelines.
During the study, all data is reviewed by an independent Safety Monitoring Board. This group of experts can stop the study at any time if they feel that the risks for participants are too great. In addition, AIDS Research Alliance has an independent Institutional Review Board that reviews all of the details of the trial. These groups also make certain that the rights of participants are protected.
It is important for participants to know that any new study vaccine may have both medical and non-medical risks, and there may be additional risks that we do not know about yet. Before joining the study, volunteers are provided with information about HIV/AIDS, reasons for the study, possible risks and benefits, and trial procedures. Clinic staff spends significant time talking with volunteers and answering their questions. This information is also provided in writing.
For more information on participants' rights, please visit www.hvtn.org/community/rights.html.
If I volunteer, is there anyway I can change my mind later?
Although we would like our volunteers to be committed to completing the study, you are free to withdraw from the study at any time.
What will happen to participants who become HIV-infected during this study?
It's important to note that participants can still get infected with HIV through sexual contact, sharing of injection drug equipment, or any other exchange of blood or bodily fluids, even if they are receiving the study vaccine.
Study participants are counseled to avoid behavior that would put them at risk of HIV infection. Those who become infected during the study will stop receiving injections and will continue to be monitored for the rest of their scheduled time in the study. Participants who become infected during the trial will be referred to an appropriate doctor or medical agency for medical care.
Who is conducting this study?
This study is being conducted in 10 US cities by various research agencies under the direction of the HIV Vaccine Trials Network (HVTN). AIDS Research Alliance is serving as HVTN’s Los Angeles site for this study. Since 1989, AIDS Research Alliance has conducted more than 100 HIV/AIDS studies, including two of the first HIV vaccine trials.
HVTN is a global partnership of researchers, governments, pharmaceutical companies, academic institutions, and community members. HVTN is dedicated to conducting international clinical HIV vaccine trials in the safest, most efficient way possible. The HVTN is funded and supported by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), an agency of the US Department of Health and Human Services (DHHS).
For more information on AIDS Research Alliance, visit www.aidsresearch.org
For more information on HVTN, visit www.hvtn.org