Controlled human malaria infection after immunization with frozen Plasmodium falciparum parasites under chloroquine prophylaxis

Phase 1

• Conditions: Controlled human malaria infection after immunization with cryopreserved Plasmodium falciparum sporozoites under chloroquine prophylaxis.; Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

• Registration Number: EUCTR2012-000322-21-NL
• Lead Sponsor: Sanaria Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-27
• Last Update Posted: 10 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Healthy volunteers (males or females) of = 18 and = 35 years of age
2.Good health based on history and clinical examination (physical examination and laboratory screening)
3.Negative pregnancy test
4.Use of adequate contraception for females
5.Signing of the informed consent form, thereby demonstrating understanding of the meaning and procedures of the study
6.Agreement to inform the general practitioner and to sign a request to release medical information concerning contraindications for participation in the study
7.Willingness to undergo administration of PfSPZ Challenge by needle and syringe and willingness to undergo challenge by mosquito bites
8.For volunteers not living in Nijmegen: agreement to stay in a hotel room close to the trial centre or living in Nijmegen with a third party that could contact the clinicians in case of alteration of consciousness during a part of the study (day 5 after challenge until treatment is finished)
9.Reachable (24/7) by mobile phone during the whole study period
10.For volunteers living in Nijmegen: living with a third party that could contact the clinicians in case of alteration of consciousness or agreement to stay in a hotel room close to the trial centre during a part of the study (day 5 after challenge until treatment is finished)
11.Available to attend all study visits
12.Agreement to refrain from blood donation to Sanquin or for other purposes, during the whole study period
13.Willingness to undergo HIV, hepatitis B and hepatitis C tests
14.Negative urine toxicology screening test at screening visit and the day before challenge
15.Willingness to take a prophylactic regime of chloroquine and a curative regimen of Malarone®
16.Willingness to undergo ophthalmologic examination after passing all other inclusion criteria

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.History of malaria
2.Plans to travel to malaria endemic areas during the study period
3.Plans to travel outside of the Netherlands during the challenge period
4.Previous participation in any malaria vaccine study and/or positive serology for Pf
5.Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers
6.History of diabetes mellitus or cancer (except basal cell carcinoma of the skin)
7.History of arrhythmias or prolonged QT-interval
8.Positive family history of 1st and/or 2nd degree relatives who experienced cardiac events when < 50 years old
9.An estimated, ten year risk of fatal cardiovascular disease of =5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system
10.Clinically significant abnormalities in electrocardiogram (ECG) at screening
11.Body Mass Index (BMI) below 18 or above 30 kg/m2
12.Any clinically significant deviation from the normal range in biochemistry or haematology blood tests
13.Positive HIV, HBV or HCV tests
14.Participation in any other clinical study within 30 days prior to the onset of the study
15.Enrolment in any other clinical study during the study period
16.For women: pregnancy or lactation
17.Volunteers unable to give written informed consent
18.Volunteers unable to be closely followed for social, geographic or psychological reasons
19.History of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study
20.A history of psychiatric disease
21.A history of convulsions
22.Known hypersensitivity to Malarone® or chloroquine
23.The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months of study onset (inhaled and topical corticosteroids are allowed) and during the study period
24.Contraindications to Malarone® or chloroquine including treatment taken by the volunteer that interferes with Malarone® or chloroquine
25.Any confirmed or suspected immunosuppressive or immunodeficient condition, including asplenia
26.Co-workers or trainees of the departments of Medical Microbiology or Internal Medicine of the RUNMC
27.Known history of sickle cell anaemia, sickle cell trait, thalassemia, thalassemia trait or G6PD deficiency. If there is any suspicion of G6PD deficiency (based on medical history during screening or ethnic background (Mediterranean, African, or Asian), we will assess G6PD status of that particular subject before inclusion.
28.Abnormalities during ophthalmologic examination

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified