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Completed

NCT Number: NCT01031524

Trial to Assess the Efficacy of Malaria Vaccine PfCS 102

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.

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Key information

Conditions

Plasmodium Falciparum Malaria Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Ambulatory Care and Community Medicine; University Hospital

Lausanne, 1011, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PfCS102

Biological

Antigen of the sporozoite protein

Montanide ISA 720

Biological

adjuvant alone

Primary outcomes

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

    Time frame: 1month

Secondary outcomes

  1. Incidence of adverse events

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Swiss Tropical & Public Health Institute

Other

Collaborators

  • Centre Hospitalier Universitaire Vaudois
  • Radboud University Medical Center

Registry information

Official study 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

Acronym: DG002

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Dec 14, 2009
Registry last updated
Dec 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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