FAQs for Potential Volunteers in HIV Vaccine Research
- Can I get HIV/AIDS from an investigational vaccine?
No. You cannot get an HIV infection from the vaccine 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.
- Who can participate in a vaccine trial?
Men and women of all racial/ethnic backgrounds are encouraged to volunteer. You
must be in good health and must be HIV-negative (you must not be infected with HIV).
For most trials, volunteers are 18 to 50 years old. There may be other requirements
for your specific trial that will be explained to you.
- 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.
- What side effects can I expect from the investigational vaccine?
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. The staff at the trial
site are available to discuss any side effects and to advise you on treatment, if
needed. Before the study, a clinician will describe all possible side effects.
- 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, there are ways to assist you with
this in the rare event it happens. 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 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, so that clinicians
can perform more sensitive tests that will accurately determine whether you have
contracted HIV due to an actual natural exposure. 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 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.
- 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 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 this vaccine works?
At specific intervals after receiving each injection, specialized blood tests are
done to see if your immune system responds to the vaccine. The results of these
tests will be evaluated and compared to what researchers already know about vaccine-induced
protective responses. The researchers will also compare the rate of infection in
those who received the vaccine with those who received a placebo 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 it to the investigational vaccine. You will not be exposed to HIV as part
of the trial at any time, and we ask you 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. Trials seeking to create a safe, effective
vaccine are an important part of a global effort to prevent the further spread of
- 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.
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.
Information published courtesy of NIAID
This article was last modified in: 06/18/2012