- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01002833
Comparison of Three Plasmodium Falciparum Isolates in an Experimental Human Malaria Infection (TIP1)
November 8, 2010 updated by: Radboud University Medical Center
Plasmodium falciparum isolates display a wide genetic diversity with possibly different properties to induce immune responses.
These properties could directly influence the ability to induce protective efficacy.
Since 1998 an experimental human malaria infection model at the Radboud University Nijmegen Medical Center (RUNMC) has been very successful in answering questions with regards to immunological mechanisms of human Pf infection.
To date only the NF54 strain of Pf has been deployed in this Nijmegen model.
However, investigation of heterologous Pf challenge is not only highly informative for our basic understanding of induction of immune responses but also provides an essential model for protective capacity testing in the clinical development of candidate malaria vaccines.
Recently, the parasite culture laboratory of the RUNMC has been able to overcome technical hurdles to produce infectious mosquitoes of two genetically different isolates from different geographical regions to increase the portfolio for Phase IIa trials.
These isolates, PfA and PfB will be compared with the NF54 strain for parasitic, immunological and clinical features in humans.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Leiden, Netherlands, 2300 RC
- Leiden University Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age > 18 and < 35 years healthy volunteers (males or females)
- General good health based on history and clinical examination
- Negative pregnancy test
- Use of adequate contraception for females
- All volunteers have to sign the informed consent form following proper understanding of the meaning and procedures of the study
- Volunteer agrees to inform the general practitioner and agrees to sign a request for medical information concerning contra-indications for participation in the study
- Willingness to undergo a Pf sporozoite challenge
- Agreement to stay in a hotel room close to the trial center during a part of the study (Day 5 till Day T +3)
- Reachable by mobile phone during the whole study period
- Available to attend all study visits
- Agreement to refrain from blood donation to Sanquin or for other purposes, during the course of the study
- Willingness to undergo an HIV, hepatitis B and C test
- Negative urine toxicology screening test at screening visit and day before challenge
- Willingness to take a curative regimen of Malarone®
Exclusion Criteria:
- History of malaria
- Plans to travel to endemic malaria areas during the study period
- Previous participation in any malaria vaccine study and/or positive serology for Pf
- 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
- History of diabetes mellitus or cancer (except basal cell carcinoma of the skin)
- History of arrhythmia's or prolonged QT-interval
- Positive family history in 1st and 2nd degree relatives for cardiac disease < 50 years old
- An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system
- Body Mass Index (BMI) below 18 or above 30 kg/m2
- Any clinically significant deviation from the normal range in biochemistry or haematology blood tests or in urine analysis
- Positive HIV, HBV or HCV tests
- Participation in any other clinical study within 30 days prior to the onset of the study
- Volunteers enrolled in any other clinical study during the study period
- Pregnant or lactating women
- Volunteers unable to give written informed consent
- Volunteers unable to be closely followed for social, geographic or psychological reasons
- Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study
- A history of psychiatric disease
- Known hypersensitivity for anti-malaria drugs
- History of severe reactions or allergy to mosquito bites
- The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months before study onset (inhaled and topical corticosteroids are allowed) and during the study period
- Contra-indications to Malarone® including treatment taken by the volunteers that interfere with Malarone®
- Any confirmed or suspected immunosuppressive or immunodeficiency condition, including asplenia
- Co-workers of the departments of Medical Microbiology or Internal Medicine of the Radboud University Nijmegen Medical Centre or Leiden University Medical Center
- A history of sickle cell, thalassaemia trait and G6PD deficiency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PfA
Exposure of human volunteers to bites of mosquitoes infected with the A strain of Plasmodium falciparum
|
Healthy volunteers are exposed to the bites of 5 Plasmodium falciparum infected mosquitoes
|
Experimental: PfB
Exposure of human volunteers to bites of mosquitoes infected with the B strain of Plasmodium falciparum
|
Healthy volunteers are exposed to the bites of 5 Plasmodium falciparum infected mosquitoes
|
Active Comparator: NF54
Exposure of human volunteers to bites of mosquitoes infected with the NF54 strain of Plasmodium falciparum
|
Healthy volunteers are exposed to the bites of 5 Plasmodium falciparum infected mosquitoes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
A significant difference in kinetics of parasitemia between groups A, B and C
Time Frame: 35 days
|
35 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Immunological properties of different Plasmodium falciparum isolates
Time Frame: 140 days
|
140 days
|
Time to thick smear positivity between groups A, B and C
Time Frame: 35 days
|
35 days
|
Maximum parasitemia and duration of parasitemia as measured by PCR
Time Frame: 35 days
|
35 days
|
Frequency of signs and symptoms between groups A, B and C
Time Frame: 140 days
|
140 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Coffeng LE, Hermsen CC, Sauerwein RW, de Vlas SJ. The Power of Malaria Vaccine Trials Using Controlled Human Malaria Infection. PLoS Comput Biol. 2017 Jan 12;13(1):e1005255. doi: 10.1371/journal.pcbi.1005255. eCollection 2017 Jan.
- Teirlinck AC, Roestenberg M, van de Vegte-Bolmer M, Scholzen A, Heinrichs MJ, Siebelink-Stoter R, Graumans W, van Gemert GJ, Teelen K, Vos MW, Nganou-Makamdop K, Borrmann S, Rozier YP, Erkens MA, Luty AJ, Hermsen CC, Sim BK, van Lieshout L, Hoffman SL, Visser LG, Sauerwein RW. NF135.C10: a new Plasmodium falciparum clone for controlled human malaria infections. J Infect Dis. 2013 Feb 15;207(4):656-60. doi: 10.1093/infdis/jis725. Epub 2012 Nov 27.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
October 26, 2009
First Submitted That Met QC Criteria
October 26, 2009
First Posted (Estimate)
October 27, 2009
Study Record Updates
Last Update Posted (Estimate)
November 9, 2010
Last Update Submitted That Met QC Criteria
November 8, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TIP1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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