Completed clinical studies
Research with new transmission-blocking malaria vaccine (2021-2022)
R0.6C is a vaccine aimed at blocking the spread of malaria. In this study (called STOP-TRANS study) we study the safety and possible side effects of the R0.6C vaccine and whether the R0.6C vaccine elicits immunity in healthy subjects. We are testing R0.6C in two different strengths in healthy study participants. The results of this research are important to further develop the R0.6C vaccine to stop the spread of malaria.
Results: will be published within a year.
TB31F study - research with a medicinal product (2019 -2021)
TB31F is an antibody which we believe may stop transmission (spreading) of malaria to a next person. TB31F has been tested in the laboratory and in animals but it has not been tested in humans before. In this study, TB31F will be tested in various dosages. The results of this research are important for the development of TB31F as a medicine to stop the spread of malaria.
Results:
This new drug TB31F, blocks the transmission of malaria parasites by mosquitoes from human to human.
Administration to healthy study participants appears safe and the drug in the blood of volunteers prevents malaria parasite reproduction in the mosquito. Therefore the are not able to infect new human victims with malaria. A single injection of the drug could prevent transmission of parasites, and thus new malaria cases, during an entire malaria season.
This is only a first step in testing this new drug. Further studies, especially in malaria endemic areas, are needed before it can be widely deployed.
Manuscript: https://pubmed.ncbi.nlm.nih.gov/35963275/
CPS135 malaria study - 2019-2020
In this study we wish to investigate the Safety and protective efficacy of chemoprophylaxis and sporozoite immunization with Plasmodium falciparum NF135 against homologous and heterologous challenge infection in healthy study participants in the Netherlands.
Publication: https://doi.org/10.1186/s12916-023-02788-9
CHMI-Trans1 & CHMI-Trans2 study (2018)
The primary aim of these projects was to develop a controlled human malaria infection transmission model (“CHMI-trans”) or ‘challenge model’ to evaluate the capacity of vaccines, biologics (monoclonal antibodies, or mAbs), and drugs to block malaria parasite transmission. CHMI-trans2 was a sequel on CHMI-trans1 for the optimization of the transmission model.
Outcome: A clinical protocol to measure transition of the malaria parasite from men to mosquito. The novel clinical model will allow testing of transmission-blocking interventions.
Links:
https://www.ncbi.nlm.nih.gov/pubmed/29482720
https://pubmed.ncbi.nlm.nih.gov/32239171/
PbVac study (2017/2018)
This study was focused on the safety and protective efficacy of genetically modified Plasmodium berghei (Pb(PfCS@UIS4)) malaria parasites in healthy study participants. This multi-center study was performed in close collaboration with Erasmus MC.
Outcome: Immunization with PbVac is safe and well tolerated with induction of functional immune responses in in vitro assays. No complete protection was not observed, but there was significant delay in parasite patency after the controlled human malaria infection challenge.
Link: https://pubmed.ncbi.nlm.nih.gov/32434846/
GA1 study (2017/2018)
The primary aim of this project was to determine the safety and tolerability of direct venous inoculation (DVI) of PfSPZ-GA1 in healthy study participants. Secondary we aimed to investigate the short-term protective efficacy of PfSPZ-GA1 against Controlled Human Malaria Infection (CHMI) by mosquito bite. The GA1 study was a multi-center study with Leiden University Medical Center
Outcome: Immunisations with PfSPZ-GA1 are well tolerated and safe with modest induction of immune responses and modest protection after challenge. However, no definite conclusion can be drawn from this trial on the potential protective efficacy PfSPZ-GA1.
Link: https://pubmed.ncbi.nlm.nih.gov/32434847/