Trial to Assess the Efficacy of Malaria Vaccine PfCS 102

Study Overview
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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.

Official Title
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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

Conditions
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Plasmodium Falciparum Malaria

Intervention / Treatment
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* Biological: PfCS102
* Biological: Montanide ISA 720


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vaccine<br>30 µg of PfCS102 formulated in Montanide ISA 720 | Biological: PfCS102<br>* Antigen of the sporozoite protein<br>|
| Placebo Comparator: adjuvant<br>Montanide ISA 720 | Biological: Montanide ISA 720<br>* adjuvant alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy |  | 1month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plasmodium falciparum malaria