This thesis describes the development and clinical testing of the late arresting genetically attenuated malaria parasite (GAP) GA2: after confirming its attenuation phenotype in humans, the preliminary protective efficacy of the GAP was assessed against controlled human malaria infection (CHMI) with the homologous parasite strain Pf3D7. Additionally, the factors influencing the motivation and decision-making process of medical volunteers taking part in early drug and vaccine studies were analysed, specifically focussing on SARS-CoV-2 vaccine trial participants and analysing the differences between phase 1 clinical trials and controlled human infection (CHI) studies.
GAPs that arrest late in the liver stage of malaria have the potential to increase immunogenicity and protective efficacy. GA2, the first late-arresting GAP to be developed and tested in humans, has shown to be both safe and well-tolerated with high rates of protection in malaria-naïve individuals....
Show moreThis thesis describes the development and clinical testing of the late arresting genetically attenuated malaria parasite (GAP) GA2: after confirming its attenuation phenotype in humans, the preliminary protective efficacy of the GAP was assessed against controlled human malaria infection (CHMI) with the homologous parasite strain Pf3D7. Additionally, the factors influencing the motivation and decision-making process of medical volunteers taking part in early drug and vaccine studies were analysed, specifically focussing on SARS-CoV-2 vaccine trial participants and analysing the differences between phase 1 clinical trials and controlled human infection (CHI) studies.
GAPs that arrest late in the liver stage of malaria have the potential to increase immunogenicity and protective efficacy. GA2, the first late-arresting GAP to be developed and tested in humans, has shown to be both safe and well-tolerated with high rates of protection in malaria-naïve individuals. While further research is needed to confirm these preliminary findings, GA2 could represent a new tool in the fight against malaria.
The investigation of malaria vaccine candidates relies on clinical testing and hence on the participants who volunteer their time to help the advancement of science. The ethical implications of research involving humans are far-reaching and have been extensively discussed. One of the concerns is that the monetary compensation phase 1 participants receive, may cause them to overlook the risks and dangers of research. However, as outlined in this thesis, medical volunteers have a variety of motivations for participating in clinical trials, which are not all financial in nature. Rather than providing a definitive answer to this complex ethical debate, we would like to highlight the importance of being aware and respecting the value of clinical trial participants’ commitment to science.
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