Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04788862
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2021-02-25
Brief Title:
A Study of Blood-stage Controlled Human Plasmodium Falciparum Malaria Infection in Tanzania
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
Open Label Trial to Establish a Blood-stage Controlled Human Malaria Infection Model and Determine Its Safety in Healthy Tanzanian Adults With Varying Prior Exposure to P Falciparum
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be a single-centre open label trial to determine the safety and feasibility of CHMI model using Plasmodium falciparum-infected cryopreserved erythrocytes administered to healthy Tanzanian adults with varying prior exposure to P falciparum
Detailed Description:
This study will be a single-centre controlled human malaria infection study using adults with varying degrees of prior exposure to P falciparum The study will take place at Bagamoyo Clinical Trail Facility of the Ifakara Health Institute located in Bagamoyo town about 60 km north of Dar es Salaam
Twelve healthy male adults aged 18 to 35 years will be recruited into two cohorts of high and low previous exposure consisting of 6 volunteers each as determined by anti-schizont antibody levels Up to 5 back-up volunteers will be also be recruited and may take the place of another volunteer should they withdraw or become ineligible prior to challenge
Participants will be infected via IV administration of Plasmodium falciparum-infected human erythrocytes of the chloroquine-susceptible 3D7 strain Participants will then be closely monitored in a clinical trial facility for a maximum of 31 28 days plus 3 days of treatment with anti-malarial drugs days while undergoing frequent clinical and laboratory assessment Volunteers who do not reach malaria treatment criteria as per protocol at day 28 C28 will be treated presumptively with antimalarial medications ALU a single low dose primaquine under direct observation and will be discharged upon completion of treatment and on discretion of the study clinician
Identifying data will not be included on any trial documentation other than signed consent and participants will be referred to by the trial study ID number The study will be funded primarily by EDCTP grant supporting the evaluation of Multi-Stage Malaria Vaccine
Twelve healthy male adults aged 18 to 35 years will be recruited into two cohorts of high and low previous exposure consisting of 6 volunteers each as determined by anti-schizont antibody levels Up to 5 back-up volunteers will be also be recruited and may take the place of another volunteer should they withdraw or become ineligible prior to challenge
Participants will be infected via IV administration of Plasmodium falciparum-infected human erythrocytes of the chloroquine-susceptible 3D7 strain Participants will then be closely monitored in a clinical trial facility for a maximum of 31 28 days plus 3 days of treatment with anti-malarial drugs days while undergoing frequent clinical and laboratory assessment Volunteers who do not reach malaria treatment criteria as per protocol at day 28 C28 will be treated presumptively with antimalarial medications ALU a single low dose primaquine under direct observation and will be discharged upon completion of treatment and on discretion of the study clinician
Identifying data will not be included on any trial documentation other than signed consent and participants will be referred to by the trial study ID number The study will be funded primarily by EDCTP grant supporting the evaluation of Multi-Stage Malaria Vaccine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None