Trial to Assess the Efficacy of Malaria Vaccine PfCS 102 (DG002)

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

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.

Study Overview

• Status: Completed
• Conditions: Plasmodium Falciparum Malaria
• Intervention / Treatment: Biological: PfCS102; Biological: Montanide ISA 720

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1011
    • Department of Ambulatory Care and Community Medicine; University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vaccine; 30 µg of PfCS102 formulated in Montanide ISA 720	Biological: PfCS102; Antigen of the sporozoite protein
Placebo Comparator: adjuvant; Montanide ISA 720	Biological: Montanide ISA 720; adjuvant alone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	15 days

Collaborators and Investigators

• Sponsor: Swiss Tropical & Public Health Institute
• Collaborators: Radboud University Medical Center; Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Blaise Genton, MD PhD, University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (Actual): July 1, 2004
• Study Completion (Actual): November 1, 2004

Study Registration Dates

• First Submitted: December 9, 2009
• First Submitted That Met QC Criteria: December 11, 2009
• First Posted (Estimate): December 14, 2009

Study Record Updates

• Last Update Posted (Estimate): December 14, 2009
• Last Update Submitted That Met QC Criteria: December 11, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Plasmodium falciparum malaria
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria; Malaria, Falciparum; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Monatide (IMS 3015)
• Other Study ID Numbers: 09/04