Frequently Asked Questions
What is a clinical vaccine trial?
What is a Phase I, II, or III trial?
Can anyone join a research study?
Are these vaccines safe?
Could I be infected with HIV by this vaccine?
Will the vaccine I'll receive protect me against HIV
infection?
Can this vaccine or its effects be passed on to my
partner or family?
Will I know what vaccine I'm receiving?
How do I enroll in a study?
What is Informed Consent?
Will it cost me anything?
Will I still need my own doctor?
Who protects me while I'm in the trial?
Who's in charge of the trial?
Why join a study?
How do I finally decide?
What is a clinical vaccine trial?
A vaccine trial is a test of an experimental vaccine in people. In VTU
vaccine
trials, selected volunteers receive a vaccine designed to
prevent HIV infection. Their responses to the vaccine are carefully
monitored to determine how well the vaccine is
tolerated and how it stimulates the immune system. To have a true
comparison, some participants are given a
placebo, an inactive substance or substitute, instead of
the experimental vaccine. You will not know whether you have
received the vaccine or a placebo until the end of the
trial.
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What is a Phase I, II, or III trial?
There are three types, or phases, of vaccine trials
involving people:
A phase I trial studies side effects to make sure the
vaccine is safe, and also studies whether the vaccine can elicit an
response from the immune system. Phase I trials may also determine the
most effective dosage and vaccination
schedule.
A phase II trial takes the most promising vaccine(s) from Phase I trials.
In phase II, the vaccine is administered to
many more people than in phase I to collect more information on the
vaccine's possible side effects and its effects on the immune
system. A phase II trial can last up to a few years, and
may involve hundreds of people.
Phase III tests the protective benefits of a vaccine in
thousands of people. In these large studies, researchers may also identify
rare side effects that were not seen in smaller studies.
The VTU has participated in Phase I and II trials thus far.
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Can anyone join a trial?
No. Different studies have different requirements.
Whether a person can enroll in a trial depends on that
trial's particular needs.
Participants must be in good health and 18-50 years of
age. Because a study lasts 1 to 2 years, the
volunteer must be planning to live in the area at least
that long.
Women who are pregnant or planning to become pregnant in
the next year may not join a vaccine study.
People of color and ethnic minorities are encouraged to
apply. The participation of people from diverse ethnic
backgrounds is essential to our understanding of how a
vaccine will work throughout the world.
Factors that could exclude a volunteer from participation
in the study include: being HIV positive, certain medical
conditions, a history of serious allergic reactions and the
use of certain prescription medications.
Rejection from one study does not automatically
disqualify a volunteer from other studies.
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Are these vaccines safe?
The effects of the drugs being tested are not fully
known. The vaccine might produce pain, tenderness, redness or swelling at
the
injection site, or perhaps mild flu-like symptoms. Often, the recipient
feels no side effects at all. Every
drug is tested for many years to watch for possible side
effects.
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Could I be infected with HIV by this vaccine?
No, you cannot. The vaccines include only genetically
engineered copies of HIV proteins or HIV genes, designed to stimulate a
response in your immune system. The vaccines are not made from live or
killed or weakened HIV. No one can be HIV-infected by the
vaccine.
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Will the vaccine I'll receive protect me against
HIV infection?
No. There is, as yet, no vaccine to prevent HIV infection.
That's what these trials are all about. Since all the
vaccines are still being studied, you must practice the
safest behavior possible.
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Can this vaccine or its effects be passed on to my partner
or family?
Most of the vaccines we use are not known to be transferrable by close or
intimate contact.
You will be informed beforehand if precautions are advised with certain
vaccines. Women
who are pregnant or planning to become pregnant in the next year may not
join a vaccine study.
The vaccines we use are not known to affect future childbearing.
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Will I know what vaccine I'm receiving?
During your screening, you'll be told about what specific
vaccines or vaccines are being tested in the study.
Neither you nor your clinician will know whether you
receive a vaccine or a placebo (an inactive substance). This is called a
"double
blind," and guarantees that all participants are studied
and followed in exactly the same way. After the trial,
you and your clinician are told which vaccine you
received--or if you received a placebo. You will not be
able to participate in further HIV vaccine studies. You may,
however, be asked to be involved in follow-up studies.
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How do I enroll in a study?
Call the clinic at (206) 667-2300. First you will be asked some
questions to find out if you meet the basic requirements
for a study. If you do, you will be scheduled for a screening visit.
During the screen, the clinician will explain the study to
you in complete detail. You'll be asked
detailed questions about your health and your sexual
behavior. During the interviews, ask as many questions
as you wish. Blood tests, including an HIV test, are done. If your initial
tests show that you are
potentially eligible, you'll be scheduled for a complete
physical exam. When that's all done, you can be scheduled
for your first vaccination. You will also be asked to sign
an Informed Consent agreement.
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What is Informed Consent?
Informed Consent means that after being informed of all
the risks of the study and your responsibilities, you
consent, or agree, to enroll. Joining a
vaccine study means that you agree to meet the
study schedule and requirements. If you don't feel
comfortable with this, or if you can't make all the
appointments, talk to the people running the trial.
Perhaps they can be flexible, or together you may
decide that you cannot participate in the study. The
Informed Consent is not legally binding. You may
discontinue the study at any time.
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Will it cost me anything?
The vaccines (or placebos) used in the studies are given
free, as are the tests and exams you receive throughout
the trial. A small amount of money is usually given to
participants each time they receive the vaccine, to offset
the costs of participating--bus fare, time off from work,
or childcare costs.
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Will I still need my own doctor?
Yes. Joining a vaccine study is not the same as receiving
health care. Even while you are participating in a clinical
study, it is very important to maintain regular visits with
your doctor. The clinicians at the VTU are not
responsible for providing primary healthcare, although
they will be glad to answer any questions you might
have. Your trial clinician will be glad to talk with your
regular doctor about your participation in the study.
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Who protects me while I'm in the trial?
Every institution that conducts medical research
involving people as volunteers is required by the federal
government to have an Institutional Review Board (IRB).
The IRB is a group of people from various professions
who protect the rights of people in a trial. The board
reviews the trial on a regular basis. Nationally, the Data
and Safety Monitoring Board also reviews on-going
research. A Community Advisory Board made up of
volunteers and interested individuals outside the studies
also reviews all protocols. This board maintains a hotline
to receive volunteers' questions and concerns.
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Who's in charge of the trial?
The person in charge of a vaccine trial is a doctor, who
is called the "principal investigator." Physicians, nurses
and nurse-practitioners perform exams, take blood,
answer questions, and vaccinate and interview you.
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Why join a study?
There is no direct benefit from volunteering in an HIV
vaccine study. Most people join because they want to
help find a way to end the HIV epidemic.
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How do I finally decide?
Get the facts. Talk to a clinician to see what will happen
during the trial, and what's expected of you. Talk to
other participants, and see how they feel about their
involvement. We can arrange a confidential phone
conversation between you and a trial participant, so you
can ask them questions about their participation. Talk
with your regular healthcare providers about these
studies, and encourage them to call the VTU if they
don't know about the trials. Think it over. And don't join
a trial until you are comfortable with all you've learned.
It is important to
understand that the researchers plan their trials around
the participants; test results can lose their meaning
when volunteers drop out. If you think you might drop
out for any reason, it would be better not to enroll.
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