A clinical trial is a test of a new medicinal product in human
subjects. Before a new drug or vaccine can enter into clinical
trials, it must undergo rigorous laboratory tests to establish
its safety and then it has to be approved by the
MHRA and COREC. All clinical trials also have to be approved by an Ethics
Committee before they are carried out. Initial clinical studies
of vaccines are carried out in small numbers (10 to 20) of healthy
volunteers (phase 1) before going on to larger field studies of
hundreds of volunteers (phase 2) and then studies of thousands
of individuals (phase 3). The aims of vaccine studies are initially
to demonstrate that the new vaccines are safe and that they can
stimulate an immune response and ultimately to see whether they
are effective in preventing disease.
No. Different clinical trials have different inclusion and exclusion
criteria. We are looking for healthy adults aged between 18 and
50 who have never had malaria. Volunteers should live in the Oxford
area and be able to travel easily to the Churchill Hospital where
the trials are conducted. Any serious medical condition would
exclude someone from volunteering. Women who are pregnant or intending
to become pregnant cannot participate in these studies.
Before entering into clinical trials, the vaccines have to undergo
rigorous toxicology testing in the laboratory and have to be approved
for use by the
(who regulate the use
of all drugs in the United Kingdom). Vaccination may be associated
with no side effects or symptoms. However, the vaccines may cause
some transient redness and tenderness at the site of vaccination.
Additionally volunteers may experience some short-lived flu-like
symptoms. Clinical trials of similar vaccines indicate that these
vaccines are likely to be safe.
No. We do not know at this stage whether the vaccines will offer
protection against malaria and so travellers would need to take
the relevant anti-malaria tablets if travelling to areas where
malaria is prevalent.
We believe that these studies are safe. After infection with malaria
there is an intensive period of follow-up with regular checks
for malaria infection. As soon as any malaria parasites are seen
in the blood, the volunteers are given the treatment. The treatment
is 100% effective and this type of malaria does not recur. During
this study, the clinical trial physicians are available 24 hours
a day to answer any concerns of volunteers.
No. The malaria used in the challenge study is falciparum malaria
and this does not recur. The strain used is a laboratory strain
and is 100% curable by a number of anti-malaria drugs including
Chloroquine. Other types of malaria can recur throughout a person's
life such as vivax malaria but this is not used in these studies.
No. It is impossible to spread malaria from person to person by
everyday contact. Malaria is a blood-borne pathogen and so volunteers
infected with malaria should not give blood.
There is no direct health benefit to volunteers taking part in
these studies. However, the information that we gain from them
is invaluable in the development of new malaria vaccines that
may help to prevent millions of deaths each year if successful.
The Principal Investigator, Professor Adrian Hill, is in charge
of the Malaria Vaccine Trials. The day-to-day running of the trials
is done by the Research Physicians.
Yes. This is a clinical study of new malaria vaccines and volunteers
should still see their GP for routine health matters. Volunteers
are encouraged to discuss any of their concerns during the study
with one of the trial physicians. The trial physicians are available
24 hours per day via the study pager.
You would need to contact the Malaria Vaccine Trials team (see
contact us [link to relevant page]) to get more information about
current studies so that you can decide whether you really want
to take part. The trials team would ask you some questions to
make sure that you were eligible to participate. If you decided
to enter a study, then you would need to attend a screening visit.
This is a general health check with a physical examination by
a doctor and a blood test to make sure that you are fit to take
part in the study.