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Controlled Human Malaria Infection study to assess gametocytaemia and mosquito transmissibility in participants challenged with Plasmodium falciparum by sporozoite challenge to establish a model for the evaluation of transmission-blocking interventions

Primary objectives:1) To evaluate the safety of four different CHMI-trans protocols in healthy malaria-naïve volunteers challenged with Plasmodium falciparum by sporozoite challenge. 2) To determine the best CHMI-trans protocol for induction of…

Controlled Human Malaria Infection study to assess gametocytaemia and mosquito transmissibility in participants challenged with Plasmodium falciparum by sporozoite challenge to establish a model for the evaluation of transmission-blocking interventions

Primary objectives:1) To evaluate the safety of CHMI-trans protocols in healthy malaria-naïve volunteers challenged with Plasmodium falciparum by sporozoite challenge and blood stage challenge. 2) To assess gametocyte infectiousness for Anopheles…

Safety and protective efficacy of chemoprophylaxis and sporozoite immunization with Plasmodium falciparum NF135 against homologous and heterologous challenge infection in healthy volunteers in the Netherlands

Primary Objective: To determine the safety and tolerability of NF135.C10 sporozoite immunization under chemoprophylaxisSecondary Objectives:• To determine the dose-dependent protective efficacy of NF135.C10 CPS-immunization against homologous…

Identification of pre-erythrocytic target antigens induced by Plasmodium falciparum sporozoite immunization under chemoprophylaxis.

Primary objective: To delineate the antibody repertoire directed against the pre-erythrocytic stages of Plasmodium falciparum induced by CPS-immunization.Secondary objectives: • To assess the functionality of CPS-immunization induced antibodies.• To…

Experimental human malaria infection after immunization with Plasmodium falciparum sporozoites under chloroquine prophylaxis.

Primary objective: To investigate whether CPS immunization confers protection to a blood stage challenge.Secondary objectives: • To study and compare parasitemia after challenge between study groups• To analyze and compare the immune responses…

Experimental human malaria infection by intradermal injection of Plasmodium falciparum sporozoites (PfSPZ Challenge)

• Primary objective: To achieve a 100% infection rate of human volunteers by intradermal injection of aseptic, purified, cryopreserved Pf sporozoites (PfSPZ Challenge). • Secondary objective: To compare parasite kinetics between different doses of…

Re-exposure of previously immunized and challenged human volunteers to a heterologous strain of P. falciparum sporozoites

To determine protective immunity against a heterologous P. falciparum sporozoites re-challenge after previous CPS immunization and challenge.

Re-exposure of EHMI-8 human volunteers to live malaria sporozoites

Objectives: • Primary objective (parasitological): To explore the longevity of immunity against P. falciparum sporozoite challenge that was induced in the EHMI-8 study. • Secondary objective (immunological): To dissect mechanisms of protection and…

Safety, Tolerability and Plasmodium falciparum transmission-reducing activity of R0.6C vaccine adjuvanted with Alhydrogel alone or combined with Matrix-M in healthy malaria-naïve adults in the Netherlands

Primary safety objective: 1) To evaluate safety of R0.6C immunizations in healthy malaria-naïve volunteers in four dose-adjuvant combinations.Primary efficacy objective:1) To assess transmission reducing activity (TRA) to mosquitoes in the standard…

Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics and pharmacodynamics of monoclonal antibody TB31F in healthy malaria-naïve adults in the Netherlands

(protocol section 2) This phase 1 study aims to assess the safety and tolerability of monoclonal antibody TB31F administered intravenously or at escalating dose levels or subcutaneously in healthy, malaria naïve, adults. This study will also…

Safety and protective efficacy of genetically modified Plasmodium berghei (Pb(PfCS@UIS4)) malaria parasites in healthy volunteers

Phase 1Primary objective:To determine the safety and tolerability of administration of Pb(PfCS@UIS4) to healthy volunteers delivered by infectious mosquito bites.Secondary objective:Immunogenicity of Pb(PfCS@UIS4) as assessed by ELISA and IFA.…