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Trial to Assess the Efficacy of Malaria Vaccine PfCS 102

NCT01031524 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2009-12-14

No results posted yet for this study

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.

Conditions

  • Plasmodium Falciparum Malaria

Interventions

BIOLOGICAL

PfCS102

Antigen of the sporozoite protein

BIOLOGICAL

Montanide ISA 720

adjuvant alone

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • Swiss Tropical & Public Health Institute

    lead OTHER

Principal Investigators

  • Blaise Genton, MD PhD · University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2004-07-31
Completion
2004-11-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01031524 on ClinicalTrials.gov