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

Primary Purpose

Plasmodium Falciparum Malaria

Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
PfCS102
Montanide ISA 720
Sponsored by
Swiss Tropical & Public Health Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Plasmodium Falciparum Malaria focused on measuring Plasmodium falciparum malaria

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Ambulatory Care and Community Medicine; University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

vaccine

adjuvant

Arm Description

30 µg of PfCS102 formulated in Montanide ISA 720

Montanide ISA 720

Outcomes

Primary Outcome Measures

Length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy

Secondary Outcome Measures

Incidence of adverse events

Full Information

First Posted
December 9, 2009
Last Updated
December 11, 2009
Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Centre Hospitalier Universitaire Vaudois, Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01031524
Brief Title
Trial to Assess the Efficacy of Malaria Vaccine PfCS 102
Acronym
DG002
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

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Centre Hospitalier Universitaire Vaudois, Radboud University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasmodium Falciparum Malaria
Keywords
Plasmodium falciparum malaria

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vaccine
Arm Type
Experimental
Arm Description
30 µg of PfCS102 formulated in Montanide ISA 720
Arm Title
adjuvant
Arm Type
Placebo Comparator
Arm Description
Montanide ISA 720
Intervention Type
Biological
Intervention Name(s)
PfCS102
Intervention Description
Antigen of the sporozoite protein
Intervention Type
Biological
Intervention Name(s)
Montanide ISA 720
Intervention Description
adjuvant alone
Primary Outcome Measure Information:
Title
Length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy
Time Frame
1month
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blaise Genton, MD PhD
Organizational Affiliation
University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ambulatory Care and Community Medicine; University Hospital
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

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Trial to Assess the Efficacy of Malaria Vaccine PfCS 102

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