Trial to Assess the Efficacy of Malaria Vaccine PfCS 102

Plasmodium Falciparum Malaria Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031524
• Other study ID #: 09/04
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 9, 2009
• Last updated: December 11, 2009
• Start date: March 2004
• Est. completion date: November 2004

Study information

• Verified date: December 2009
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Plasmodium Falciparum Malaria

Intervention

Biological:
• PfCS102
Antigen of the sporozoite protein
• Montanide ISA 720
adjuvant alone

Locations

Country	Name	City	State
Switzerland	Department of Ambulatory Care and Community Medicine; University Hospital	Lausanne

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	Centre Hospitalier Universitaire Vaudois, Radboud University

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy		1month	No
Secondary	Incidence of adverse events		15 days	Yes