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

This study has been completed.
Sponsor:
Collaborators:
Centre Hospitalier Universitaire Vaudois
Radboud University
Information provided by:
Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier:
NCT01031524
First received: December 9, 2009
Last updated: December 11, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Plasmodium Falciparum Malaria
Biological: PfCS102
Biological: Montanide ISA 720
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Swiss Tropical & Public Health Institute:

Primary Outcome Measures:
  • Length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy [ Time Frame: 1month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: March 2004
Study Completion Date: November 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01031524

Locations
Switzerland
Department of Ambulatory Care and Community Medicine; University Hospital
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Swiss Tropical & Public Health Institute
Centre Hospitalier Universitaire Vaudois
Radboud University
Investigators
Principal Investigator: Blaise Genton, MD PhD University Hospital
  More Information

No publications provided

Responsible Party: Blaise Genton, Department of Ambulatory care and Community Medicine, University of Lausanne
ClinicalTrials.gov Identifier: NCT01031524     History of Changes
Other Study ID Numbers: 09/04
Study First Received: December 9, 2009
Last Updated: December 11, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by Swiss Tropical & Public Health Institute:
Plasmodium falciparum malaria

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014