Trial to Assess the Efficacy of Malaria Vaccine PfCS 102 (DG002)
This study has been completed.
Sponsor:
Swiss Tropical & Public Health Institute
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
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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
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 May 22, 2013