Phase 1, dose escalation, randomized controlled trial to evaluate the safety, immunogenicity and efficacy of intravenously administered attenuated Plasmodium falciparum sporozoite vaccine (PfSPZ Vaccine) in Tanzanian adults
Malaria is one of the most severe diseases in tropical countries. During the last decade, great effort has led to success in controlling malaria transmission, morbidity and mortality. Nevertheless, still around 660 000 people die due to malaria infection per year. For further reduction and, ideally, to gain elimination of this of this burden, a vaccine is crucial. Since longtime, this purpose has been under investigation. Now, the vaccine PfSPZ (Plasmodium falciparum sporozoites) yields hope.
A study in the USA showed that this vaccine is safe, immunogenic and efficient in non-immune participants. These participants represented a non-endemic population, but are there any differences between naïve and endemic populations? To address this question, this phase I study will take place in Tanzania. Healthy voluntary Tanzanians will participate in this dose escalation, randomized trial. They will receive either lower doses of PfSPZ, higher doses of PfSPZ or doses of placebo. First, the researchers will investigate safety and tolerability of the vaccine as well as induction of immune response. Afterwards, protective efficacy is tested by controlled human malaria infection (see associated website).
Ideally, this study will demonstrate the safety, immunogenicity and efficiency of the PfSPZ in endemic population. This will signify an important step towards the long-term goal: the elimination of malaria.