Trial to Assess the Efficacy of Malaria Vaccine PfCS 102

NCT01031524 | Completed Phase 1

• 1 other identifier: 09/04
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Plasmodium falciparum malaria

Outcome Measures

Primary Outcomes (1)

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

  1month

Secondary Outcomes (1)

• Incidence of adverse events

  15 days

Study Arms (2)

vaccine

EXPERIMENTAL

30 µg of PfCS102 formulated in Montanide ISA 720

Biological: PfCS102

adjuvant

PLACEBO COMPARATOR

Montanide ISA 720

Biological: Montanide ISA 720

Interventions

PfCS102 BIOLOGICAL

Antigen of the sporozoite protein

vaccine

Montanide ISA 720 BIOLOGICAL

adjuvant alone

adjuvant

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• resident in or near Lausanne;
• age \>18 and \<45 years;
• written informed consent;
• \>10/12 correct responses to the questionnaire of understanding.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• Centre Hospitalier Universitaire Vaudois: collaborator
• Radboud University Medical Center: collaborator

Study Sites (1)

Department of Ambulatory Care and Community Medicine; University Hospital

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

circumsporozoite protein (282-383), Plasmodium falciparum; mannide monooleate

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Blaise Genton, MD PhD

  University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 14, 2009
• Study Start: March 1, 2004
• Primary Completion: July 1, 2004
• Study Completion: November 1, 2004
• Last Updated: December 14, 2009

Record last verified: 2009-12

Locations

CH (1)