RecruitingNot ApplicableNCT05071079

A Controlled Human Vivax Malaria Infection Study Through Inoculation of Infected Erythrocytes

A Clinical Study to Assess the Safety and Feasibility of Controlled Blood-stage Plasmodium Vivax Human Malaria Infection Through Experimental Inoculation of Cryopreserved Infected Erythrocytes in Healthy Thai Adults


Sponsor

University of Oxford

Enrollment

48 participants

Start Date

May 23, 2022

Study Type

INTERVENTIONAL

Conditions

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 differing quantities and stages of parasites. The total number of volunteers of this study will be up to 48 (8 volunteers per inocula stock). The volunteers will be monitored closely as in-patients in the Hospital for Tropical Diseases, and will be treated according to the Research Proposal. This study is funded by the UK Wellcome Trust. The grant reference number are Oxford/MORU: 212336/Z/18/Z and 212336/Z/18/A, and Mahidol University: 212336/A/18/Z and 212336/A/18/A.


Eligibility

Min Age: 20 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called An inoculum of malaria parasitised red blood cells with 1:10 dilution blood-stage inoculum, a biological treatment called An inoculum of malaria parasitised red blood cells with 1:20 dilution blood-stage inoculum, and others for people with plasmodium vivax infection. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALAn inoculum of malaria parasitised red blood cells with whole dose blood-stage inoculum

An inoculum of malaria parasitised red blood cells reconstituted in 0.9% normal saline, to a total volume of 5 mL; challenge with whole dose blood-stage inoculum (neat)

BIOLOGICALAn inoculum of malaria parasitised red blood cells with 1:5 dilution blood-stage inoculum

An inoculum of malaria parasitised red blood cells reconstituted in 0.9% normal saline, to a total volume of 5 mL; challenge with 1:5 dilution blood-stage inoculum

BIOLOGICALAn inoculum of malaria parasitised red blood cells with 1:10 dilution blood-stage inoculum

An inoculum of malaria parasitised red blood cells reconstituted in 0.9% normal saline, to a total volume of 5 mL; challenge with 1:10 dilution blood-stage inoculum

BIOLOGICALAn inoculum of malaria parasitised red blood cells with 1:20 dilution blood-stage inoculum

An inoculum of malaria parasitised red blood cells reconstituted in 0.9% normal saline, to a total volume of 5 mL; challenge with 1:20 dilution blood-stage inoculum


Locations(1)

Faculty of Tropical Medicine

Bangkok, Thailand

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05071079


Related Trials