Primary objective (parasitological): To induce protection against malaria by exposure to infectious mosquito bites under chloroquine prophylaxis. Secondary objectives (immunological): 1. To induce an effective immune response against natural malaria…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints (parasitological):
1. A significant difference in time of thick smear positivity between exposed
and control groups
2. A significant difference in parasitemia as measured by 18S Pf NASBA between
exposed and control group
3. A significant difference in kinetics of parasitemia between exposed and
control groups as measured by 18S Pf NASBA.
4. A difference in occurrence or height of fever between exposed and control
groups.
Secondary outcome
Secondary endpoints (immunological):
1. Significant differences in immune response between exposed and control
volunteers
2. Significant differences in the outcome of in vitro functional malaria assays
between exposed and control volunteers
3. Significant differences in cellular reactivity against Pf antigens
4. Significant differences in parasite VAR gene expression during infection
5. The identification of immune mechanisms that correlate with protection
6. The identification of potential vaccine candidates that correlate with
protection
Exploratory endpoints (pathophysiological):
1. To identify early changes in iron metabolism
2. To identify early plasma changes in endothelial activation markers
3. To identify early changes in flow-mediated vasodilatation (FMD)
Background summary
Development of a malaria vaccine is hampered by our limited knowlegde of
(immunological) correlates of protection. Therefore it is of the utmost
importance that factors that contribute to protection are identified, in order
to develop a vaccine.
Study objective
Primary objective (parasitological): To induce protection against malaria by
exposure to infectious mosquito bites under chloroquine prophylaxis.
Secondary objectives (immunological):
1. To induce an effective immune response against natural malaria parasites in
healthy human volunteers by exposure to infectious mosquito bites under
chloroquine prophylaxis.
2. To dissect mechanisms of protection and identify correlates of protection.
Exploratory objectives (pathophysiological): To explore the pathophysiology of
early malarial infection, with specific attention to:
1. iron metabolism
2. endothelial activation markers
3. endothelial reactivity
Study design
Trial design : unicenter, double blind, randomised
Trial procedure : Volunteers will be exposed to the bites of infectious
mosquitoes 3 times (interval 1 month) with live P. falciparum sporozoites under
chloroquine prophylaxis. Challenge with infected mosquitoes will be given 28
days after stopping chloroquine prophylaxis.
Intervention
Volunteers will be exposed to infectious mosquitoe bites. They will be treated
with chloroquine, and later with riamet.
Study burden and risks
The main burden to the volunteers that is related to this study is the
intensive follow-up period with many visits and venapunctures.
Postbus 9101
6500 HB Nijmegen
Nederland
Postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Healthy 18-45 y/o
Exclusion criteria
Systemic disorders
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-006074-16-NL |
| CCMO | NL14967.091.06 |
| Other | nog niet bekend |