About Preventive HIV Vaccines
Can I get HIV/AIDS from an investigational vaccine?
Will the vaccines being tested cause me to transmit HIV?
How will you know if a vaccine works?
About Preventive HIV Vaccine Clinical Trials
What is the time commitment for participating in a vaccine trial?
If I receive a study vaccination, will I test positive on an HIV test?
If I am in a vaccine study, am I protected from infection with HIV?
Health and Safety Questions
What side effects can I expect from the vaccines being tested?
Are there nonmedical risks to participating in a vaccine trial?
If I decide to participate, can I change my mind later?
About Preventive HIV Vaccines
Can I get HIV/AIDS from an investigational vaccine?
No. You cannot get infected with HIV from the vaccines being tested. In
vaccine trials, scientists create synthetic (man-made) genes. These synthetic genes make proteins that resemble those that are present in a real
virus, but they do not contain the information required to cause HIV infection. There is no virus or infected material in the investigational vaccine,
so there is no way that it can cause HIV/AIDS.
Will the vaccines being tested 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 whole HIV. Therefore, it is impossible to become HIV infected or develop AIDS from
the investigational vaccine or to transmit the virus as a direct result of receiving the vaccine.
How will you know if a vaccine works?
At specific times after receiving each injection, specialized
blood tests are done to see if your immune system responds to the vaccine. The researchers will also compare the rate of infection in those who
received the vaccine with those who received a placebo (inactive substance) injection to determine if there is a difference. If the rate of HIV
infection for those who received the vaccine is substantially lower than those who did not receive the vaccine, we will attribute the lower rate
of HIV infection to the investigational vaccine.
You will not
be exposed to HIV as part of the trial at any time, and you will be asked to avoid any risk that may cause you to be
exposed to the virus. Specific, ongoing counseling will be available to help you stay HIV uninfected during the trial.
About Preventive HIV Vaccine Clinical Trials
What is the time commitment for participating in a vaccine trial?
The time commitment varies from study to study. In general,
the first few visits are the longest because you are learning about the study, reviewing and completing the informed consent form, and undergoing
the screening physical and tests. Each study is different, but visits will require anywhere from 30 minutes to 3 hours. A typical trial lasts between
12 and 24 months and requires between 6 and 20 visits.
If I receive a study vaccination, will I test positive on an HIV test?
The most common HIV test checks
for antibodies to HIV, not for the presence of the virus itself. Investigational vaccines are designed specifically to
create immunity against HIV that may include the production of antibodies. If a study vaccine causes an antibody response,
it can result in a false-positive result on an HIV test. Because of this, you should limit your HIV testing strictly to the
study site or a lab referred to you by the site, so that clinicians can perform more sensitive tests that will accurately determine
whether you have contracted HIV outside the study. Since there is no live virus in any investigational HIV vaccines, you cannot
be infected with HIV or develop AIDS from the vaccine being tested. There are no known medical side effects associated with
having a false-positive antibody test.
If I am in a vaccine study, am I protected from infection with HIV?
You should not assume that you are protected from HIV because
of your participation in a vaccine trial. You should continue to practice safe sex and limit yourself to single-use, non-shared needles. It is
not known if a study vaccine will protect you from HIV, and you may have received a placebo injection, not the vaccine itself. If you think you
might be exposing yourself to HIV infection, you should seek counseling to protect yourself from doing so.
Health and Safety Questions
What side effects can I expect from the vaccines being tested?
Typically, there are few, if any, side effects reported by
vaccine trial volunteers. However, there may be short-term side effects similar to those from other vaccinations: arm soreness, fever, headache,
or fatigue. The side effects usually do not last long, and participants rarely require medical intervention. Trial site staff are available to
discuss any side effects and to advise you on treatment, if needed. Before joining a study, a clinician will describe all possible side effects
during the informed consent process—the process of deciding whether or not to join a clinical
trial, after learning enough information to make a responsible decision about participating.
Are there nonmedical risks to participating in a vaccine trial?
Some volunteers have reported that others have treated them
poorly when they learned about their participation in a trial. Some people erroneously believe that a trial participant
must be infected with HIV, even though volunteers must be HIV-negative to participate. On rare occasions, you may have difficulty
obtaining health insurance and/or traveling outside of the country. However, clinical trial staff and NIAID staff will assist
you with this in the event you experience trial-related discrimination. It is important to note that other than the study site
staff, no one will be informed that you are an HIV vaccine trial volunteer unless you make the decision to tell them yourself.
If I decide to participate, can I change my mind later?
You are encouraged to take your time in coming to a decision to participate
in a vaccine trial, so that you are comfortable and fully informed before enrollment. If you wish, you may want to speak with your doctor, family,
and friends before you decide to participate. It is always a voluntary decision to continue in a study, and you can withdraw at any time without
any negative consequences.
FAQ Source Information
McCluskey MM, Alexander SB, Larkin BD, Murguia M, Wakefield S. "An HIV Vaccine: As We Build It,
Will They Come?" Health Affairs 2005;
24(3):643-51.
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About the Campaign
The HIV Vaccine Communications Campaign was formed to create an environment in which HIV affected communities and individuals at higher risk for HIV infection are more aware, educated, and supportive of HIV vaccine research and have more positive attitudes towards clinical trial volunteerism.
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