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

S

Swiss Tropical and Public Health (TPH) Institute

Status and phase

Completed
Phase 2
Phase 1

Conditions

Plasmodium Falciparum Malaria

Treatments

Biological: Montanide ISA 720
Biological: PfCS102

Study type

Interventional

Funder types

Other

Identifiers

NCT01031524
09/04

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

16 participants in 2 patient groups, including a placebo group

vaccine
Experimental group
Description:
30 µg of PfCS102 formulated in Montanide ISA 720
Treatment:
Biological: PfCS102
adjuvant
Placebo Comparator group
Description:
Montanide ISA 720
Treatment:
Biological: Montanide ISA 720

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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