A new study out of Copenhagen has just broken some incredible news within the medical community. A vaccine that protects against pregnancy malaria has just passed a human safety check.
This is a major development in the fight against the deadly disease that kills over 220,000 people every year. The vaccine, which has already spent several years in development, was recently tested in a phase one clinical trial - and the results were extremely promising.
"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," said study co-author Morten Agertoug Nielsen, an assistant professor in the immunology and microbiology department at the University of Copenhagen.
Morten and his team examined the effect of the vaccine using a randomized, double-blind study. In a randomized, double-blind study, test subjects randomly receive either the vaccine or the placebo, and neither them, nor the researchers, know who gets what. Test subject volunteers - a total of 36 German men and women - were studied to see which effects, if any, resulted from the vaccine. To do so, researchers monitored for side effects when they detected the right immune response with antibodies against the malaria parasite in the blood.
Because the German test subjects are not and will not be exposed to the parasite, they are referred to as "malaria naïve." However, this trial was simply to document that the vaccine is safe and appears to work, which is crucial for the next steps: introducing it to a group of African women who are at risk of developing pregnancy malaria.
"We will be doing more tests, because we want to take the vaccine as far as we can," said study co-author and professor of immunology and microbiology, Ali Salanti. "We are therefore cooperating with hospitals in Benin in Africa, where we can conduct studies in women in risk of developing the disease."
Salanti was the one who discovered the protein hook in the placenta of pregnant women that the malaria parasite attaches itself to. Since this discovery, Salanti and his team have used this to work towards producing a vaccine. According to Nielsen, phase two is a two-fold process: first, it will determine whether the vaccine is still safe, and second, it must show whether it can prevent disease.
"The crux of the matter is whether [the method we developed for transforming the vaccine into a virus-like particle] is sufficient for attacking all the different forms of the protein hook found in the malaria parasite," he said.