Clinical Trials
About Clinical Studies Core |
VRC
Home |
Frequently Asked Questions
How long are
vaccine studies, and how much time will I have to commit? |
Most studies
are about one year long. There may be 1 to 4 injections
and about 7 to 14 clinic visits depending upon the study
plan. Screening and injection visits can take up to 4
hours. All other visits are usually under an hour.
|
Where and when can
I go for appointments? |
Research study visits are at the Vaccine
Research Center Clinic at the National Institutes of Health
in Bethesda, Maryland. Free valet parking is available.
You can also get there by Metro. Take the Red Line, and
get off at the Medical Center Metro Station. Clinic hours
are Monday through Friday from 8:00 AM to 4:30 PM. We
can usually schedule clinic visits at other times; but
we cannot conduct visits on holidays or weekends.
|
How
can I find out if I can be in the vaccine research study? |
Please call
the Vaccine Research Center toll-free at 1-866-833-LIFE
(5433), or email us at VRCForLife@mail.nih.gov.
We are looking for healthy volunteers 18 to 60 years old.
We will ask you a few questions about your health. If
you meet certain criteria, we will set up a screening
visit. At this visit we will do a complete physical exam
and blood work to see if you are eligible to participate
in a vaccine clinic trial.
|
What side effects can I expect
from an investigational vaccine? |
You might have short-term
side effects, similar to those from any vaccination, such
as arm soreness or feeling tired or unwell. Since these
are the first studies of the vaccines in people, there
may be risks or side effects that are not known. We will
discuss potential side effects with you before you enroll.
|
Can
I donate blood during or after a study? |
You cannot donate blood,
blood products such as platelets, or bone marrow during
participation in the research study. In addition, blood
banks will not accept donations for one year after the
last dose of an investigational vaccine. Also, please
do not donate blood six weeks before you come in for screening.
|
Will I be paid for my
participation? |
Yes, volunteers are compensated for travel
expenses and time lost from work. These payments are not
likely to fully cover your real costs, however. Payments
are made after each visit. Most studies offer about $200
for vaccination visits, and $175 for most other visits,
but compensation varies by study.
|
What if I move
out of town? |
If you move out of the
area within the first few months of starting a study,
we may not be able to monitor you adequately. When you
contact a VRC staff member, please discuss with us any
relocation or extended travel plans.
|
Protocol Specific FAQs
Preventive HIV Vaccine Development
Can I get HIV/AIDS
from the investigational vaccine? |
No. You cannot get an
HIV infection from the vaccine. In this investigational
vaccine, scientists created synthetic (man-made) genes.
These synthetic genes are designed to make proteins that
resemble those present in a real virus. They do not contain
the information required to cause HIV infection. Proteins
in the vaccine are present for a short time before being
broken down by the body. These proteins are look-alikes,
are not live, so they cannot cause HIV. There is no virus
or infected material in the investigational vaccine, so
there is no way that it can cause HIV/AIDS.
|
How does this investigational HIV
vaccine work? |
The vaccine is designed to work by mimicking
the shapes and structures of HIV proteins. They cause
the immune system to produce antibodies and lymphocyte
responses that may recognize and attack HIV. In this way
the immune system may be educated to recognize and potentially
respond quickly if you were to encounter HIV. The hope
is that the body's natural immunity prepared by vaccination
will be able to fight off a real HIV exposure. Please
remember that this is an investigational vaccine. We don't
know if it works and extensive testing will be needed
to eventually answer this question.
[Adenovirus specific]: This vaccine is part
of a generation of vaccines called "vaccine vectors."
A vector is a packaging system that can help deliver
the vaccine more effectively into the right part of
the body or into the right cell, in order to produce
the best possible immune responses. In this study, an
adenovirus vector carries synthetic genes into human
cells. The adenovirus shell protects the vaccine genes
until they are in a cell that can produce the vaccine
protein. The adenovirus can not reproduce, cause infection,
or damage the immune system, and the HIV genes can not
produce infection or reassemble to make a virus.
|
What if I test
"false-positive" for HIV? |
To be eligible for a
study you must be HIV negative. Some investigational vaccines
may be strong enough to cause an antibody response detectable
on standard HIV tests. These tests measure the body's
antibody response to HIV, and do not directly measure
HIV itself. Therefore, having a false-positive antibody
test for HIV after vaccination is not unexpected. It does
not mean you are infected. At every visit, we perform
specialized testing to prove that you are not HIV infected.
No medical side effects or problems are associated with
having a false-positive antibody test. Remember, this
vaccine contains no live virus, so you cannot be infected
with HIV or develop AIDS from this vaccine.
|
Will this vaccine protect me from
HIV? |
No. There is no evidence that this investigational
vaccine will protect you from getting HIV infection. The
main purpose of this study is to test whether the investigational
vaccine is safe. You should avoid high-risk behavior that
would put you at risk for HIV infection.
|
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 HIV; therefore,
it is impossible to be infected with HIV or develop AIDS
from the vaccine.
|
How will you know if this vaccine
works? |
Certain times after receiving each injection,
specialized laboratory testing will be done on your blood
to see if your immune system responds to the vaccine.
The results of these tests will be evaluated and compared
to what we have learned about vaccine-induced protective
responses in animal studies. We will not expose you to
the virus at any time and ask that you avoid any risk
that may cause you to be exposed to the virus. Specific
counseling will be available to help you stay HIV uninfected
during the trial. This vaccine is part of a global effort
to create a safe, effective vaccine for HIV. After trials
are completed at this site, our vaccine will be placed
into expanded clinical trials in the United States and
around the world. Eventually large trials will be done
to see if the vaccine can reduce the rate of HIV infection.
|
Protocol Specific FAQs
Avian Influenza Vaccine Development
Can I get Avian
Influenza from the investigational vaccines being studied
at the VRC? |
No. You cannot get Avian
Influenza infection from the vaccines being studied at
the VRC. Scientists use synthetic (man-made) genes in
developing the investigational vaccines. These synthetic
genes allow the body's cells to make proteins similar
to those in a real virus but they do not have the genetic
information needed for Avian Influenza infection. The
proteins coded for by the vaccine that are made by the
body are only present for a short time before being broken
down. There is no Avian Influenza virus in the investigational
vaccines, so it is not possible for them to cause Avian
Influenza infection.
|
How are the investigational vaccines
supposed to work? |
The vaccine contains the DNA that codes for Avian Influenza
proteins. After vaccination, the body should make Avian
Influenza proteins for a short time. If this happens,
the immune system will be able to make antibodies and
cellular immune responses to these proteins. In this way
the immune system may recognize and respond quickly to
Avian Influenza in the future. Please remember that the
vaccines are investigational. We don't know if they work.
The first studies are to see if the vaccines are safe.
More testing will be needed eventually to see if vaccinations
can prevent Avian Influenza infection.
|
Will an investigational
vaccine protect me from Avian Influenza? |
The main purpose of this
research study is to test whether the investigational
vaccine is safe and well-tolerated. Since the VRC is studying
the new investigational vaccine for the first time, there
is no evidence about whether or not it will work. During
a study blood samples are collected at certain times after
each injection is given. Laboratory tests will be done
on your blood samples to see if your immune system responds
to the vaccine. The results of these blood tests will
be compared to the kind of immune responses seen in studies
where a vaccine protected animals from infection with
the Avian Influenza virus. We will not expose you to the
Avian Influenza virus at any time. This study will also
help us develop a plan of future investigation in order
to learn whether vaccination against Avian Influenza virus
works.
|
Will an investigational vaccine
cause me to spread Avian Influenza? |
No. The VRC Avian Influenza vaccines are
not made from live virus or Avian Influenza infected cells.
We will not expose you to the Avian Influenza virus at
any time. You cannot spread Avian Influenza virus from
the vaccine.
|
Protocol Specific FAQs
Ebola Vaccine Development
Can I get Ebola
from the investigational vaccines being studied at the
VRC? |
No. You cannot get Ebola
infection from the vaccines being studied at the VRC.
Scientists use synthetic (man-made) genes in developing
the investigational vaccines. These synthetic genes allow
the body's cells to make proteins similar to those in
a real virus but they do not have the genetic information
needed for Ebola infection. The proteins coded for by
the vaccine that are made by the body are only present
for a short time before being broken down. There is no
Ebola virus in the investigational vaccines, so it is
not possible for them to cause Ebola infection.
|
How are the investigational vaccines
supposed to work? |
The vaccine DNA codes for Ebola proteins.
After injection, the body should make Ebola proteins for
a short time. If this happens, the immune system will
be able to make antibodies and cellular immune responses
to these proteins. In this way the immune system may recognize
and respond quickly to Ebola in the future. Please remember
that the vaccines are investigational. We don't know if
they work. The first studies are to see if the vaccines
are safe. More testing will be needed eventually to see
if vaccinations can prevent Ebola infection.
|
Will an investigational
vaccine protect me from Ebola? |
The main purpose of this
research study is to test whether the investigational
vaccine is safe and well-tolerated. Since the VRC is studying
the new investigational vaccine for the first time, there
is no evidence about whether or not it will work. During
a study blood samples are collected at certain times after
each injection is given. Laboratory tests will be done
on your blood samples to see if your immune system responds
to the vaccine. The results of these blood tests will
be compared to the kind of immune responses seen in studies
where a vaccine protected animals from infection with
the Ebola virus. We will not expose you to the Ebola virus
at any time. This study will also help us develop a plan
of future investigation in order to learn whether vaccination
against Ebola virus works.
|
Will an investigational vaccine
cause me to spread Ebola? |
No. The VRC Ebola vaccines are not made
from live virus or Ebola infected cells. We will not expose
you to the Ebola virus at any time. You cannot spread
Ebola virus from the vaccine.
|
Why is the VRC
studying more than one kind of investigational Ebola virus
vaccine? |
The human immune system
is complicated. Different kinds of vaccines cause different
kinds of immune responses. Studying more than one vaccine
type allows us to compare responses. Also, we can see
if using a schedule that includes more than one type of
investigational vaccine might give a better response than
a schedule that includes only one type of vaccine.
|
If you have a question about a particular
VRC clinical trial, and it isn't answered here or elsewhere
on our website, please contact us via e-mail at VRCforlife@mail.nih.gov
or call 1-866-833-LIFE (5433).
|