Frequently Asked Questions for Vaccine Studies
What is a vaccine study?
A vaccine is given to prevent infection or fight
disease. Currently there is no vaccine against HIV.
Part of the process of finding an HIV vaccine is testing
study vaccines that seem most likely to help the body
fight HIV. A vaccine study is a standard way to test
a specific study vaccine so that researchers can prove
that the study vaccine is safe, and can find out more
about whether it might work to prevent or fight disease.
Volunteers who participate in HIV vaccine studys play
an important part in this scientific research.
Can I get HIV from the 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 vaccines either living or dead.
Can a study vaccine cause HIV infection?
It is impossible to get HIV infection or develop
AIDS from experimental vaccines. They are not made
from live HIV, killed HIV, weakened HIV, or HIV-infected
cells. The investigational vaccine in our studys
cannot cause HIV infection.
What are the side-effects?
Possible side effects of the injections could include
fever, chills, rash, aches and pains, nausea, headache,
dizziness, and fatigue. Injections can cause pain,
soreness, redness, and swelling on the part of the
body where you receive the vaccine shot. The side
effects usually do not last long and participants
usually do not need any form of treatment. However,
if necessary, a clinician will advise you on treatment.
Will I test HIV positive as a result
of the vaccine?
The most common test for HIV is an antibody test.
Antibodies are proteins in the blood, made by your
body to try to defend itself against infection. If
you receive an HIV vaccine, you could develop antibodies
to the vaccine, so your HIV test could turn up antibody
positive even though you are not infected. This is
called a “false positive” or ”Vaccine Induced Seropositive“ or "VISP." VISP does NOT happen to everyone who receives
a vaccine. It also does not mean you are infected.
There are other tests for HIV that can prove that
you do not have HIV and we would do these tests in
our clinic to help you avoid any problems or misunderstandings
from testing VISP. There is NO possible
way that anyone can contract HIV or AIDS from the
Could my partner receive my antibodies?
No. Antibodies cannot be transmitted.
Does everyone get an HIV vaccine
in a vaccine study?
Some people don't. To have a true, controlled comparison,
some of the participants are given a placebo, an inactive
substance or substitute, instead of the vaccine. You
can't choose which you are given. Neither you nor
your clinician will know whether you receive a vaccine
or a placebo. This is called a "double blind"
study design and guarantees that all participants
are studied and followed in exactly the same way.
After the study is over, you and your clinician will
find out which you received—the vaccine or placebo.
Will the vaccine protect me against
No. It is not known whether any of the experimental vaccines will protect you against HIV. It is important for you to maintain a low risk of HIV infection. Your clinician will provide information and counseling on safe sex and on minimizing the risk of HIV infection.
Who is eligible to participate
in a study?
We are looking for healthy men and women, ages 18-50,
who are committed to making a difference in the fight
against HIV. Volunteers for vaccine studys should
be HIV negative and planning to stay in the Seattle
area for the duration of the study (at least 12-24
An important goal at our clinic
is diversity. People of different backgrounds may respond
differently to a vaccine and we need to make sure we
find an HIV vaccine that will work well for everybody.
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 is a study like?
A typical vaccine study lasts 12-24 months. You would go
to one or two screening visits to learn more about
the program and find out whether you are eligible
to join. If you join, you would be vaccinated approximately
3-6 times during the study. You would also come to
the clinic for about 7-10 other visits for checkups
and blood draws. Vaccine visits usually take about
90 minutes and checkups are about 30 minutes. You
will usually be seeing the same clinician (nurse or
doctor) most of the time during the study. You would
be tested for HIV several times during the study.
We would also regularly ask you questions about your
health, medications and drugs you are taking, and
your risks for HIV infection.
I work from 8AM to 6PM and I can’t
get off work. Do you have Saturday appointments or evening
Currently we have staff available from 7AM to 5:30PM
most weekdays and on Wednesdays we are in from 7AM to 8PM. We are closed on Saturdays and Sundays.
You would need to be able to have a few 90-minute
appointments for vaccination visits. If you can get
in to work at 8:30 AM a few times a year or leave
work early at 4PM or take an extended lunch break,
you might be able to join.
How will the safety and rights
of participants be protected?
Study participants play a very important role in
the search for an HIV vaccine, and the safety and
rights of participants are given the highest priority.
This study 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
During the study, all of the data is reviewed by a
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, our study location works with Fred Hutchinson Cancer Research
Institutional Review Board (IRB), sometimes called an Ethics
Committee, that reviews all of the details of the
study. 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 you join a study, volunteers are provided
with information about HIV and AIDS, about the reasons
for the study, about possible risks and benefits,
and about study procedures. Clinic staff will allow plenty
of time to talk with volunteers and answer their questions,
and information is also provided in writing.
For more information on participants' rights and responsibilites,
How do I join a study?
First, call us at 206.667.2300 so we may ask you a few simple questions and schedule a screening.
After the study has been fully explained, you will be asked to sign an informed consent form
before enrolling. This form will help to make sure
that you have been given all the information
you need. You will be given plenty of time
to consider whether or not you want to join the study.
You may decide not to join the study. If you do
enroll, you may still leave the study at any time
without losing the benefits of your standard medical
care or any other services provided at our location.
During the study, clinicians will monitor you
to make sure the study vaccine is not causing
problems. Throughout the study, any new information
researchers learn about the safety of the study vaccine
will be given to participants. You will be
able to decide whether or not to stay in the study
based on any new information we learn.
You will be reminded frequently that being part
of a vaccine study does not mean you are protected
from HIV infection. You will be offered counseling at each clinic
visit on ways to avoid HIV infection (for example,
correct and consistent condom use).
Is an investigational vaccine
Based on the data from animal studies and earlier
studys in people, scientists believe that the investigational
vaccines are safe enough to use for research. One goal of our research is to get more information about the
safety of investigational vaccines.
Many studies have previous tested some of the investigational vaccines
in more than 1000 people, many of whom were
given the investigational vaccines at the same dose
or higher than the dose used in a study you may be in.
Before being given to people, investigational
vaccines are tested in mice, rabbits, and monkeys.
While scientists believe that there are no serious
safety risks with the investigational vaccines, there
is always the possibility that there could be problems
that no one expected. This is why investigational
vaccines, like any new drug or vaccine, need to be
tested in participants in a controlled clinical setting.
Participants' health and safety will be closely monitored
throughout the study.
Because investigational vaccines do not contain
live HIV virus, there is no way for the study vaccine
to cause HIV infection.
How is the safety of an investigational
Several groups monitor our studies for safety and
make certain the study is being conducted according
to scientific and ethical standards. These groups
include the US Food and Drug Administration (FDA),
the US National Institutes of Health (NIH), the HIV
Vaccine Trials Network (HVTN), Fred Hutchinson Cancer Research Center's Institutional Review
Board and our own Community Advisory Board (CAB).
In addition, there will be an independent Data and
Safety Monitoring Board (DSMB). A DSMB is a group
of experts that are not part of the HVTN, or the researchers,
who will carefully monitor the safety of the study
participants. If there are safety concerns, the DSMB
can recommend that the study be changed or stopped.
Are there non-medical (social)
You will be asked to carefully consider all
risks before joining a study. Some risks are medical,
but there are also social risks. Study participation
takes time and commitment. It may also lead to complications
with others who do not agree with the participant's
choice to join the study, or who do not have enough
information about HIV vaccine research. For example, some
people have reported that being in a study has upset
their partner, spouse, friends or family members.
Participating in a study may also restrict the your
behavior. For instance, you will be asked not
to donate blood, and women should not get pregnant
during the study.
Some people have experienced discrimination when they
told people they were participating in clinical research
for an HIV vaccine. In the case of discrimination,
study staff can (at a participant's request and with
their permission) talk to insurance companies, employers,
and others to explain a participant's involvement
in the research.
An investigational HIV vaccine could cause a false positive
result on a standard HIV test, and such
a result may lead to being treated unfairly by others.
This will be explained to you in
more detial during the informed consent process.
It is important to remember that being given the study
vaccine does not mean you are protected
from HIV infection that is due to sexual contact,
sharing of injection drug equipment, or any other
transfer of blood or bodily fluids. We still do not
know if this study vaccine protects against infection.
You will also not know whether you
have gotten the study vaccine or the placebo, which
is an inactive substance (saline solution) that does
not provide any protection. You will be offered counseling
at every clinic visit to avoid behavior that will
put you at risk of HIV infection.
To help avoid problems that could come from participating
in a study, you will be offered an identification
card that shows that they have joined an HIV vaccine
study. A telephone number will be listed on the card
that may be called for information or for help in
I am going to move out
of the Seattle area in five months. Can I still join?
Our studies last at least 12 months and we will not
be able to enroll you unless there is a study site where you are moving to. Check out the HVTN
website and see if there’s a study site
in your new location.
What will happen to participants
if they become HIV-infected from their behavior during a study?
While the investigational vaccine cannot cause
HIV infection there is no guarantee that the investigational
vaccine will prevent HIV infection. All participants
must be HIV negative when they enroll in the 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.
Participants are offered counseling to avoid behavior that
would put them at risk of HIV infection. Those who
become infected during the study will stop receiving
injections, but clinic staff will ask to continue
monitoring their health for the rest of their scheduled
time in the study, and the researchers will test their
blood to see how the body fights the HIV infection.
There are many drugs that can be used to treat HIV
infection, but none of these drugs can cure HIV infection.
These drugs are not provided as part of this study.
Participants who become infected during the study
will be referred to an appropriate doctor or medical
agency for medical care, including antiretroviral
therapy, and counseling.
Who is conducting the studies?
The study will be conducted by the Seattle HIV Vaccine Trials Unit and HIV
Vaccine Trials Network (HVTN).
The HVTN is a global partnership of researchers, governments,
pharmaceutical companies, academic institutions, and
community members. The HVTN is dedicated to conducting
international clinical HIV vaccine studys 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
Who reviewed and approved the
Our study vaccines are considered experimental, meaning
that the FDA allows its use only in research studies.
It has been manufactured according to FDA guidelines
and was reviewed by the FDA. The protocol team (the
people from the HVTN, the pharmaceutical companies,
who designed the study also carefully reviewed the
information about the investigational vaccine before
deciding to begin the study.
The study has also been reviewed by the World
Health Organization (WHO) and the Joint
United Nations Programme on HIV/AIDS (UNAIDS).
The safety and rights of participants may also be monitored by our Institutional Biosafety Committee
(IBC) and Institutional Review Board (IRB). Community members are involved
throughout the study to ensure that the rights and
needs of participants are being met.
For more information
About the HIV Vaccine studys Network: www.hvtn.org
About AIDS vaccine clinical studys: AIDS Clinical
studys Information Service, 1-800-studyS-A (USA only);