A vaccine against fatal pregnancy malaria
shows promising results in the first tests in humans. The new study has taken a
vaccine all the way from discovery of a mechanism through development and
production to clinical trials in humans.
For many years, a team of researchers at
the University of Copenhagen have been focussing on developing a vaccine that
can protect against the disease pregnancy malaria from which 220,000 people die
every year.
Now they have come a significant step
closer to being able to introduce such a vaccine in the market. In a new study
published in the scientific journal Clinical Infectious Diseases the vaccine
has been subjected to so-called phase one clinical trial, and the results are
uplifting: The vaccine is safe to use, and it passes the test by inducing the
right antibody response in the blood.
'It is a great milestone for us to be able
to show that our vaccine is completely safe and induces the exact antibody
response in the blood we want. Because it is the immune response that has been
shown to be connected with protection from pregnancy malaria. The next step is
to document that it prevents pregnancy malaria in African women who would
otherwise have contracted the disease', says main author of the study,
Associate Professor Morten Agertoug Nielsen from the Department of Immunology
and Microbiology.
Safety
First
The researchers have applied the normal
method for testing new drugs by doing a so-called randomised, double-blind
study. This means that the test subjects were randomly given the vaccine and
placebo, respectively, and neither the subjects nor the researchers performing
the study knew who got what.
The effect of the vaccine was examined
among 36 German women and men who had volunteered for the trial. After
injecting the test subjects with the vaccine, the researchers were able to
detect the right immune response with antibodies against the malaria parasite
in the blood, and the subjects showed no serious side effects.
The German test subjects are described as
'malaria naïve', because they are not and will not be exposed to the malaria
parasite and therefore will never develop pregnancy malaria. They were
nevertheless used as test subjects to document that the vaccine is safe and
appears to work, before it is introduced in a group of African women vulnerable
and at risk of developing pregnancy malaria.
'Of course we will be doing more tests,
because we want to take the vaccine as far as we can. We are therefore
cooperating with hospitals in Benin in Africa, where we can conduct studies in
women in risk of developing the disease. We expect to be able to publish the
results of these studies sometime next year', says co-author of the study,
Professor Ali Salanti from the Department of Immunology and Microbiology.
Cooperation
Ensures Medicine for People in Need
The researchers' journey towards a malaria
vaccine began with Ali Salanti's discovery of the protein hook in the placenta
of pregnant women to which the malaria parasite may attach itself.
Subsequently, Ali Salanti and his research team have been trying to utilise
this knowledge to produce an actual vaccine against the fatal disease.
'Our development and production of the
vaccine has only been possible due to our close public-private collaborations.
It is a strong example of how such a constellation can make it possible to
develop medicine for people in need, including people with few resources', says
Professor Ali Salanti.
In academia, it is also unusual to see
researchers take their discovery further to clinical trials. Clinical trials
can be extensive and expensive, and therefore the pharmaceutical industry is
typically the one developing and safety-testing drugs before introducing them
in the market. But in this case the researchers have managed to do so
themselves.
'The next step in the process is a phase
two clinical trial, which will show whether the vaccine is still safe, but also
whether it can prevent disease. Concurrently, we have developed a method for
transforming the vaccine into a virus-like particle. This increases the
antibody response. But the crux of the matter is whether it is sufficient for
attacking all the different forms of the protein hook found in the malaria
parasite', says Associate Professor Morten Agertoug Nielsen.
Culled from Science Daily
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