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Trial record 1 of 1 for:    NCT01660854
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Re-exposure of Human Volunteers to a Heterologous Strain of P. Falciparum Sporozoites (TIP4)

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ClinicalTrials.gov Identifier: NCT01660854
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : February 13, 2013
Sponsor:
Collaborator:
Leiden University Medical Center
Information provided by (Responsible Party):
Radboud University

Brief Summary:

In a previous study (NL33904.091.10) the investigators challenged 24 volunteers after Chloroquine Prophylaxis Sporozoites (CPS) immunization with 45, 30 or 15 infected mosquito-bites respectively. The availability of this immunized cohort opens the unique opportunity to determine protection to a heterologous challenge for both of the protected and unprotected volunteers as the previous challenge infection might have served as immunological boost to the unprotected volunteers.

In the current observational, proof of principle study, the investigators aim to investigate the protection on an individual basis of these previously immunized and challenged volunteers against a heterologous P. falciparum challenge.


Condition or disease Intervention/treatment Phase
Malaria, Falciparum Biological: Heterologous challenge Drug: Malarone treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Re-exposure of Previously Immunized and Challenged Human Volunteers to a Heterologous Strain of P. Falciparum Sporozoites
Study Start Date : July 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Heterologous challenge

Biological: Heterologous challenge with 5 infected mosquito bites (NF135) after previous CPS immunization and challenge.

Drug: Malarone treatment When thick smear positive, of at day 21 after challenge, all volunteers will be treated with malarone.

Other Name: atovaquone/proguanil

Biological: Heterologous challenge
challenge by the bites of 5 Plasmodium falciparum infected mosquitoes.

Drug: Malarone treatment
Three days: 4 tablets 250/100mg per day
Other Name: atovaquon/proguanil

Active Comparator: Challenge control

Biological: Plasmodium falciparum mosquito challenge by the bites of 5 Plasmodium falciparum infected mosquitoes (NF135).

Drug: Malarone treatment When thick smear positive, of at day 21 after challenge, all volunteers will be treated with malarone.

Other Name: atovaquone/proguanil

Biological: Heterologous challenge
challenge by the bites of 5 Plasmodium falciparum infected mosquitoes.

Drug: Malarone treatment
Three days: 4 tablets 250/100mg per day
Other Name: atovaquon/proguanil




Primary Outcome Measures :
  1. Duration of prepatent period after challenge infection as measured by microscopy [ Time Frame: 21 days after challenge ]

Secondary Outcome Measures :
  1. • Parasitemia and kinetics of parasitemia as measured by PCR [ Time Frame: 21 days after challenge ]
  2. Frequency of signs or symptoms in study groups [ Time Frame: 21 days after challenge ]
  3. • Immune responses between study groups [ Time Frame: 21 days after challenge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 35 years healthy volunteers (males or females)
  2. Good health based on history and clinical examination
  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 contra-indications for participation in the study
  7. Willingness to undergo a Pf controlled challenge through mosquito bites
  8. Agreement to stay in a hotel room close to the trial centre during a part of the study (Day 5 after challenge till treatment is finished)
  9. Reachable (24/7) by mobile phone during the whole study period
  10. Available to attend all study visit
  11. Agreement to refrain from blood donation to Sanquin or for other purposes, during the whole study period
  12. Willingness to undergo HIV, hepatitis B and hepatitis C tests
  13. Negative urine toxicology screening test at screening visit and the day before challenge
  14. Willingness to take a curative regimen of Malarone®

Exclusion Criteria:

  1. History of malaria (other than participation in ZonMw1 study) or residence in malaria endemic areas within the past six months
  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 (except ZonMw1 volunteers)
  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 in 1st and 2nd degree relatives for cardiac events < 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 hematology blood tests or in urine analysis
  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. Enrollment in any other clinical study during the study period
  16. For women: being pregnant or lactating
  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
  20. A history of treatment for psychiatric disease
  21. A history of convulsions
  22. Contra-indications to Malarone®, including hypersensitivity or treatment taken by the volunteer that interferes with Malarone®
  23. The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months of study onset (inhaled and topical corticosteroids and oral anti-histaminic are allowed) and during the study period
  24. Any confirmed or suspected immunosuppressive or immunodeficient condition, including (functional) asplenia
  25. Co-workers or trainees of the departments Infectious Diseases, Medical Microbiology or Parasitology of the Leiden University Medical Centre (LUMC) or Medical Microbiology, Parasitology, Radboud University Nijmegen (RUNMC)
  26. A history of sickle cell anaemia, sickle cell trait, thalassaemia (or trait), G6PD deficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660854


Locations
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Netherlands
Leiden University Medical Centre
Leiden, Netherlands, 2333ZA
Sponsors and Collaborators
Radboud University
Leiden University Medical Center
Investigators
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Study Director: RW Sauerwein, PhD Radboud University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01660854    
Other Study ID Numbers: TIP4
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: July 2012
Keywords provided by Radboud University:
Plasmodium
falciparum
malaria
heterologous
immunity
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Proguanil
Atovaquone, proguanil drug combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action