Malaria, Plasmodium
Conditions
Interventions
Healthy, malaria-naïve adult male and female volunteers, 18 to 45 years old
Sponsors
University of Oxford
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Healthy, malaria-naïve adult aged 18 to 45 years • Able and willing to provide informed consent to participate in the study • Able and willing (in the opinion of the Investigator) to comply with all study requirements • Participants of childbearing potential only: must practice continuous highly effective contraception until 3 months after completion of Primaquine treatment • Normal G6PD screen
Exclusion criteria
Exclusion criteria: • Red blood cells negative for the Duffy antigen/chemokine receptor (DARC) • CYP2D6 genotype suggestive of poor or intermediate metabolism of Primaquine • History of clinical malaria (any species) or previous participation in any malaria vaccine trial or CHMI • Pregnancy, lactation or intention to become pregnant during the study • Any clinically significant abnormal finding on biochemistry or haematology blood tests, or clinical examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Safety of primary and relapsing P. vivax infection following sporozoite-administered CHMI as measured by (S)AE occurrences - Primary P. vivax infection following sporozoite-administered CHMI as measured by detectable parasitaemia by qPCR +/- clinical symptoms - Frequency of P. vivax relapse infections as measured by number of malaria episodes confirmed by qPCR occurring within a 6-month follow-up period after treatment of primary infection, and time to relapse infection | — |
Secondary
| Measure | Time frame |
|---|---|
| - Serological response to a panel of P. vivax antigens by ELISA | — |
Countries
Netherlands
Contacts
Public ContactB.G. Mordmüller
Radboud Universiteit Nijmegen
Outcome results
None listed