Malaria is still high on the list as one of the leading causes of deaths worldwide. While this parasitic infection is most deadly to children under five years old, pregnant women represent the second largest group to be affected by this disease. It has been estimated that pregnancy-associated malaria (PAM) results in roughly 20,000 maternal and 200,000 infant deaths annually. Now, investigators at the University of Copenhagen have just released Phase I clinical trial data from a newly developed PAM vaccine and the results are 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,” explains senior study investigator Morten Nielsen, PhD, associate professor from the department of immunology and microbiology at the University of Copenhagen. “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.”
The findings from the new study were published today in Clinical Infectious Diseases through an article titled “First-in-human, randomized, double-blind clinical trial of differentially adjuvanted PAMVAC, a vaccine candidate to prevent pregnancy-associated malaria.”
The researchers applied the normal method for testing new drugs by assembling a randomized, double-blind study. 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 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,” states co-senior study investigator Ali Salanti, PhD, a professor in the department of immunology and microbiology at the University of Copenhagen. “We expect to be able to publish the results of these studies sometime next year.”
This research towards a malaria vaccine began with Salanti’s discovery of the protein hook in the placenta of pregnant women to which the malaria parasite may attach itself. Subsequently, Salanti and his research team have been trying to utilize this knowledge to produce an actual vaccine against the fatal disease.
“Our development and production of the vaccine have 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,” remarks 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 II 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,” Nielsen concludes.