Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442377
Status:
COMPLETED
Last Update Posted:
2007-08-16
First Post:
2007-02-28
Brief Title:
Study to Investigate the Induction of an Protective Immune Response to Malaria
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Exposure of Human Volunteers to Live Malaria Sporozoites Under Chloroquine Prophylaxis
Status:
COMPLETED
Status Verified Date:
2007-08
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:
The objective of the study is to induce a protective immune response against malaria in healthy human volunteers The different parts of the immune response will then be studied
Detailed Description:
Efforts to develop vaccines against malaria still represent a substantial focus of current research activities Factors that have hampered the development of a subunit vaccine include the complexity of the malaria life cycle the wide variety of immune response induced by the malaria parasite and an incomplete knowledge of protective immunity This study is therefore aimed at inducing protective immunity against malaria in 15 healthy volunteers Volunteers will be exposed to the bites of infectious mosquitoes 3 times with live P falciparum sporozoites under chloroquine prophylaxis Challenge with infected mosquitoes will be given after stopping chloroquine prophylaxis
Five volunteers will form a control group they will be exposed to non-infectious mosquitoes under chloroquine prophylaxis
Endpoints include the time and height of parasitemia after challenge the development of fever and immunological parameters
Five volunteers will form a control group they will be exposed to non-infectious mosquitoes under chloroquine prophylaxis
Endpoints include the time and height of parasitemia after challenge the development of fever and immunological parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None