Status:
COMPLETED
Effect of Plasmodium Falciparum Exposure and Sickle Cell Trait on Infection Rates and Kinetics After IV Administration of PfSPZ Challenge
Lead Sponsor:
Sanaria Inc.
Collaborating Sponsors:
Centre de Recherche Médicale de Lambaréné
Institute of Tropical Medicine, University of Tuebingen
Conditions:
Plasmodium Falciparum Malaria
Malaria
Eligibility:
All Genders
18-30 years
Phase:
PHASE1
Brief Summary
The study is designed to establish infectivity of Plasmodium falciparum sporozoites (PfSPZ) via intravenous (IV) administration in three groups with different malaria immunity-status: 1. Adults with ...
Detailed Description
LACHMI-001 is a partially-blinded, human pilot trial to study immunity against P. falciparum malaria in a controlled infection setting. The main objective is to characterise the role of sickle cell tr...
Eligibility Criteria
Inclusion
- Healthy adult aged 18 to 30 years
- Able and willing (in the investigator's opinion) to comply with all study requirements
- Women only: must agree to practice continuous effective contraception for the duration of the study (a method which results in a low failure rate; i.e. less than 1% per year)
- Agreement to refrain from blood donation during the course of the study and after the end of their involvement in the study according to the local blood banking eligibility criteria
- Written informed consent to undergo CHMI
- Reachable (24/7) by mobile phone during the whole study period
- Willingness to take two curative anti-malarial regimens
- Agreement to stay overnight for observation during the period of intensive follow-up post-challenge if required
- Answer all questions on the informed consent quiz correctly
- A body mass index \< 35
- A haemoglobin concentration ≥10 g/dl for women and ≥12 g/dl for men
- Additional inclusion criteria for IA and IS group only:
- \- History of long term residence (\>10 years) in area known to have significant transmission of P. falciparum -
Exclusion
- Use of anti-malarials within 30 days of study enrolment
- Use of systemic antibiotics with known antimalarial activity within 30 days of study enrolment (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones, or azithromycin)
- Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period
- Prior receipt of an investigational malaria vaccine
- Immunization with more than 1 other vaccines within the past month.
- HIV infection
- Hemoglobin SS
- Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
- Use of immunoglobulins or blood products within 3 months prior to enrolment
- Pregnancy, lactation or intention to become pregnant during the study
- A history of allergic disease or reactions likely to be exacerbated by malaria
- Contraindications to the use of the first-line anti-malarial medications: artemether/lumefantrine or atovaquone/proguanil.
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of serious psychiatric condition that may affect participation in the study
- History of epileptic seizures
- Any other serious chronic illness requiring hospital specialist supervision
- Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 60 g (men) or 40 g (women) per day
- Suspected or known injecting drug abuse in the 5 years preceding enrolment
- Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for hepatitis C virus (antibodies to HCV)
- Falling in moderate risk or higher categories for fatal or non-fatal cardiovascular event within 5 years (\>10%) determined by non-invasive criteria for cardiac risk
- Abnormal electrocardiogram on screening: pathologic Q wave and significant ST-T wave changes, left ventricular hypertrophy, non-sinus rhythm except isolated premature atrial contractions, right of left bundle branch block, advanced A-V heart block (secondary or tertiary)
- A QT/QTc interval \> 450 ms
- Volunteers unable to be closely followed for social, geographic or psychological reasons
- Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination
- Any other significant disease, disorder or finding which, in the opinion of the Investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
- Additional exclusion criteria for NI group only:
- History of P. falciparum malaria
- History of long term residence (\>5 years) in area known to have significant transmission of P. falciparum
- Presence of sickle cell trait
- Known thalassemia or thalassemia trait
- Exclusion Criterion on Day of Challenge or Day before Challenge
- Acute disease, defined as moderate or severe illness with or without fever
- Pregnancy
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02237586
Start Date
July 1 2014
End Date
February 1 2015
Last Update
April 23 2015
Active Locations (1)
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1
Centre de Recherches Médicales de Lambaréné
Lambaréné, Gabon, BP 118