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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00442377
Other study ID # EHMI-8
Secondary ID
Status Completed
Phase N/A
First received February 28, 2007
Last updated August 15, 2007
Start date January 2007
Est. completion date July 2007

Study information

Verified date August 2007
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Age > 18 and < 45 years healthy volunteers (males or females).

- General good health based on history and clinical examination.

- All volunteers have to sign the informed consent form.

- Negative pregnancy test.

- Use of adequate contraception for females

- Reachable by phone during the whole study period.

- Volunteer agrees to inform the general practitioner and agrees to sign a request for medical information concerning contra-indications for participation in the trial

Exclusion Criteria:

- History of malaria or residence in malaria endemic areas within the past six months.

- Positive serology for P. falciparum

- Previously participated in any malaria vaccine study

- Symptoms, physical signs and laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers.

- Cardiovascular risk >10% according to European guidelines, taking into account sex, age, cholesterol, weight, smoking habits, blood pressure, diabetes

- Any laboratory abnormalities on screened blood samples beyond the normal range, as defined at UMC St Radboud. Positive HIV, HBV or HCV tests.

- Volunteers should not be enrolled in any other clinical trial during the whole trial period.

- Volunteers should not receive chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the three months preceding the screening visit or during the study period.

- Pregnant or lactating women.

- Volunteers unable to give written informed consent.

- Volunteers unable to be closely followed for social, geographic or psychological reasons.

- Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study.

- Known hypersensitivity for anti-malaria drugs

- Volunteers are not allowed to travel to malaria endemic countries during the study period.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Procedure:
exposure to malaria sporozoites


Locations

Country Name City State
Netherlands Radboud University Nijmegen Medical Centre Nijmegen

Sponsors (1)

Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary A significant difference in time of thick smear positivity between exposed and control groups
Primary A significant difference in parasitemia as measured by 18S Pf NASBA between exposed and control group
Primary A significant difference in kinetics of parasitemia between exposed and control groups as measured by 18S Pf NASBA.
Primary A difference in occurrence or height of fever between exposed and control groups.
Secondary Significant differences in immune response between exposed and control volunteers (including NK-cell reactivity, TLR reactivity and regulatory T-cell reactivity)
Secondary Significant differences in the outcome of in vitro functional malaria assays between exposed and control volunteers
Secondary Significant differences in cellular reactivity against Pf antigens
Secondary Significant differences in parasite VAR gene expression during infection
Secondary The identification of immune mechanisms that correlate with protection
Secondary 6. The identification of potential vaccine candidates that correlate with protection
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