Clinical trial NCT01031524: Trial to Assess the Efficacy of Malaria Vaccine PfCS 102
Official title: Randomized Double-blind Controlled Phase I/IIa Trial to Assess the Efficacy of Malaria Vaccine PfCS 102 (282-383) to Protect Against Artificial Challenge With P. Falciparum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Plasmodium Falciparum Malaria
Keywords: Plasmodium falciparum malaria
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
name: Radboud University Medical Center
First posted: 2009-12-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy
timeFrame: 1month
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 15 days
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Ambulatory Care and Community Medicine; University Hospital
Study officials:
affiliation: University Hospital
name: Blaise Genton, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: