A team of researchers from University of Copenhagen in Denmark has reported positive results from a Phase I clinical trial evaluating the PAMVAC vaccine for the treatment of pregnancy-associated malaria (PAM).
PAMVAC is a newly developed vaccine that contains alhydrogel or glucopyranosyl lipid adjuvant (GLA) based adjuvants.
The vaccine has the potential to treat pregnancy malaria, which is estimated to result in the death of 220,000 people annually.
Results of the Phase I study showed that PAMVAC was safe to use and was able to induce the right antibody response in the blood.
No serious adverse events (AE) were reported during the trial, and the distribution and severity of AE was found to be consistent in all study arms.
PAMVAC was also found to be immunogenic in all the subjects.
The study’s main author and University of Copenhagen Department of Immunology and Microbiology associate professor Morten Agertoug Nielsen said: “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.”
The Phase I trial included a first-in-human, double-blind design.
It enrolled 36 ‘malaria naïve’ German women and men, who were randomised to receive either PAMVAC or placebo.
The trial received funding from several sources including the European Union’s (EU) FP7-Health-2012-Innovation programme and the Danish National Advanced Technology Foundation.
Phase II of the trial will see the University of Copenhagen researchers further test the safety of PAMVAC in the prevention of PAM.