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AzTrials

Plasmodium FalciparumTIP1NCT01002833

Comparison of Three Plasmodium Falciparum Isolates in an Experimental Human Malaria Infection

A study testing Exposure to Plasmodium falciparum infected mosquitoes in people with Plasmodium Falciparum and Malaria, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Plasmodium Falciparum, Malaria
What is being tested?
Exposure to Plasmodium falciparum infected mosquitoes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteNetherlands
Study dates
Apr 2010to Nov 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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®

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Leiden University Medical Center

    Leiden, 2300 RC

Other trials in Netherlands

About this study

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.

Being tested
Exposure to Plasmodium falciparum infected mosquitoes
Keywords
Plasmodium falciparum, Malaria
Medical subject headings
Malaria, Falciparum, Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exposure to Plasmodium falciparum infected mosquitoesBiological

    Healthy volunteers are exposed to the bites of 5 Plasmodium falciparum infected mosquitoes

Study groups in NCT01002833
Study groupRoleWhat they receive
PfAExperimentalExposure of human volunteers to bites of mosquitoes infected with the A strain of Plasmodium falciparum
Receives: Biological: Exposure to Plasmodium falciparum infected mosquitoes
PfBExperimentalExposure of human volunteers to bites of mosquitoes infected with the B strain of Plasmodium falciparum
Receives: Biological: Exposure to Plasmodium falciparum infected mosquitoes
NF54Active comparatorExposure of human volunteers to bites of mosquitoes infected with the NF54 strain of Plasmodium falciparum
Receives: Biological: Exposure to Plasmodium falciparum infected mosquitoes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A significant difference in kinetics of parasitemia between groups A, B and C

    Measured: 35 days

Secondary outcomes (4)

  1. Immunological properties of different Plasmodium falciparum isolates

    Measured: 140 days

  2. Time to thick smear positivity between groups A, B and C

    Measured: 35 days

  3. Maximum parasitemia and duration of parasitemia as measured by PCR

    Measured: 35 days

  4. Frequency of signs and symptoms between groups A, B and C

    Measured: 140 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2009 (estimated)
  2. Study startApr 2010
  3. Primary completionNov 2010
  4. Study completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01002833
Sponsor's protocol ID
TIP1
Acronym
TIP1
Status last verified
Feb 2010
First submitted
26 Oct 2009
Last updated
9 Nov 2010
Results posted
No
Data monitoring committee
No

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.

    PubMed 28081133

  • 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.

    PubMed 23186785

Questions about this trial

What is this clinical trial studying?

A study testing Exposure to Plasmodium falciparum infected mosquitoes in people with Plasmodium Falciparum and Malaria, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A significant difference in kinetics of parasitemia between groups A, B and C (time frame: 35 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01002833, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2010.

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