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Trial to Assess the Efficacy of Malaria Vaccine PfCS 102

NCT ID: NCT01031524

Last Updated: 2009-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2004-11-30

Brief Summary

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Phase I/IIa double-blind randomized (adjuvant)-controlled trial. 16 volunteers are randomized to receive two doses of either 30 µg of PfCS102 formulated in Montanide ISA 720 (verum) or ISA 720 alone (control), 60 days apart. Two weeks after the 2nd immunization, 14 volunteers are challenged with bites of 5 infected mosquitoes using the NF54 strain of P. falciparum. The main outcome will be the length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy performed twice a day.

Detailed Description

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Conditions

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Plasmodium Falciparum Malaria

Keywords

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Plasmodium falciparum malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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vaccine

30 µg of PfCS102 formulated in Montanide ISA 720

Group Type EXPERIMENTAL

PfCS102

Intervention Type BIOLOGICAL

Antigen of the sporozoite protein

adjuvant

Montanide ISA 720

Group Type PLACEBO_COMPARATOR

Montanide ISA 720

Intervention Type BIOLOGICAL

adjuvant alone

Interventions

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PfCS102

Antigen of the sporozoite protein

Intervention Type BIOLOGICAL

Montanide ISA 720

adjuvant alone

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* resident in or near Lausanne;
* age \>18 and \<45 years;
* written informed consent;
* \>10/12 correct responses to the questionnaire of understanding.

Exclusion Criteria

* history of malaria; possible exposure to malaria within the previous 6 months;
* positive serology for PfCS102by ELISA;
* history of severe reactions or allergy to mosquito bites, artemether/lumefantrine (Riamet®) or vaccines;
* pregnant or lactating female;
* any confirmed or suspected immunodeficient condition;
* seropostivity for HIV;
* chronic or active neurological, gastrointestinal, cardio-vascular or respiratory disease;
* hemoglobinopathies;
* history of \>2 hospitalisations for invasive bacterial infections;
* requirement of any chronic medication;
* suspected or known current alcohol or illegal drug abuse (excluding cannabis);
* any other significant finding which, in the opinion of the investigator, would significantly increase the risk of having an adverse outcome from participating in this protocol or of dropping out of the study;
* a body mass index \< 18kg/m2 or \> 32 kg/m2;
* evidence of past or present psychiatric condition;
* seropositivity for HIV, hepatitis C or B (other than HBs Ab);
* 10-year risk of coronary heart disease \<10%;
* any clinically significant deviation from the normal range in biochemistry or haematology blood tests or in urine analysis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role collaborator

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role lead

Responsible Party

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Department of Ambulatory care and Community Medicine, University of Lausanne

Principal Investigators

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Blaise Genton, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital

Locations

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Department of Ambulatory Care and Community Medicine; University Hospital

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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09/04

Identifier Type: -

Identifier Source: org_study_id