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Is the center open yet? No. We are currently
building the infrastructure for the facility and anticipate the center
opening in early 2009.
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Are you recruiting volunteers? Not yet. SBRI will
begin actively recruiting volunteers for the trials closer to the time the
center opens.
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How many volunteers will you need? The number of
participants required for each trial will vary by study design and number of
trials.
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How old do you have to be to volunteer?
Eligibility criteria for each trial may vary, but in general healthy people
between the ages of 18-45 may be eligible to participate in this effort.
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Do volunteers get paid? Volunteers for clinical
trials are generally offered compensation for time and transportation. The
amount varies based on the design of each study and number of
required visits. The amount and schedule of compensation must be approved by an
independent oversight committee before the study begins. For these reasons,
it is not known at this time what the compensation for any particular trial
will be.
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Are there other centers that do this sort of testing?
Yes. The center at SBRI will be the fourth in the world. There’s a center in
England, another in the Netherlands and one at Walter Reed Army Institute of
Research (WRAIR) in Bethesda, MD. But the need is so great to develop new
solutions for malaria that additional capacity to test vaccines is required.
We’ll be working very closely with our colleagues at WRAIR to establish this
center as they have an outstanding safety record and relevant knowledge base. WRAIR
scientists will share their knowledge of how to conduct trials with SBRI
scientists, as well as provide the
mosquitoes and malaria parasites that are needed.
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Is it safe to participate in malaria clinical trials?
The model of “challenging” humans in malaria vaccine trials is a
well-established method for evaluating malaria vaccine and drug candidates.
The strain of malaria that volunteers are challenged with is a laboratory
strain that is easy to diagnose and treat because it s very responsive to
conventional malaria drugs. Other centers have conducted trials of this nature for decades with
an extensive safety record. Participants challenged with malaria may
develop flu-like symptoms with infection, but will be treated at the first
sign of infection. Out of nearly 900 people who’ve volunteered for malaria
trials at WRAIR, none have developed severe symptoms or needed to go to
hospital.
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Once the center is built, what happens next? The
first step is proving that we can infect a small number of volunteers –
typically six – with malaria through the bite of a malaria-infected
mosquito. To ensure the safety and health of our volunteers, we’ll follow
them very closely, conducting daily blood smears and treating at the first
sign of infection. Volunteers will spend a few nights at a hotel so they can
be closely monitored during the first part of the trial. After demonstrating that
volunteers can be safely infected with malaria and cured, the MCTC will be ready for trials
to assess whether or not specific candidate vaccines can prevent or delay
malaria infection.
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Why is the human challenge model helpful? It
provides researchers with valuable data to decide whether or not to move a
particular vaccine candidate forward. Focused testing at this early phase
allows more rapid assessment of candidate vaccines to select the
most effective for more wide scale testing in areas affected by malaria. By
accelerating the search for new malaria vaccines, this center will bring us
closer to the ultimate goal of eradicating malaria
