A Controlled Human Vivax Malaria Infection Study Through Inoculation of Infected Erythrocy
The primary objectives of this study are to assess the safety and feasibility of blood-stage controlled human P. vivax malaria infection (CHMI) in healthy adult Thai volunteers through experimental injection of cryopreserved P. vivax infected erythrocytes, and to choose the optimal inoculation dose for future P. vivax
| Condition(s) | Plasmodium Vivax Infection |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The primary objectives of this study are to assess the safety and feasibility of blood-stage controlled human P. vivax malaria infection (CHMI) in healthy adult Thai volunteers through experimental injection of cryopreserved P. vivax infected erythrocytes, and to choose the optimal inoculation dose for future P. vivax CHMI studies. In this study, blood-stage CHMI will be conducted in 8 volunteers per inoculum stock who will each be infected with P. vivax by experimental injection with cryopreserved P. vivax infected erythrocytes, which were collected from the controlled human Plasmodium vivax malaria infection model through experimental sporozoite infection in Thai adults (NCT04083508) . There are currently 4 stocks of inocula from 6 volunteers in the NCT04083508 study, which have differin |
| Who can participate | Inclusion Criteria: The volunteer must meet all of the following criteria to be eligible for the study: 1. Healthy Thai adult aged 20 to 55 years with weight at least 50 kg. 2. Red blood cells positive for the Duffy antigen/chemokine receptor (DARC) 3. Women only: Must practice continuous effective contraception for the duration of study period until 3 months post-challenge. 4. COVID-19 vaccination at least two doses of COVID-19 vaccines approved by WHO. 5. Agreement to refrain from blood donation during the course of the study and for 1 year after the initiation of antimalarial treatment. 6. Willing to be admitted in the Hospital for Tropical Diseases for clinical monitoring, until antimalarial treatment is completed and their symptoms are settling. 7. Willing to take a curative antimalar |
| Ages | 20 Years to 55 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of Oxford |
| Locations | Bangkok, Thailand |
| Start date | 2022-05-23 |
| NCT ID | NCT05071079 |
| Official listing | https://clinicaltrials.gov/study/NCT05071079 |