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P. Falciparum MalariaNCT00757887

Re-exposure of EHMI-8 Human Volunteers to Live Malaria Sporozoites

A study testing Exposure to 5 P. falciparum infected mosquitoes in people with P. Falciparum 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

In the EHMI-8 study (CMO 2006/207) the investigators induced sterile protection against P. falciparum challenge in healthy Dutch volunteers by repeated exposure to infected mosquitoes whilst under chloroquine prophylaxis. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
P. Falciparum Malaria
What is being tested?
Exposure to 5 P. falciparum infected mosquitoes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteNetherlands
Study dates
Oct 2009to Aug 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 P. falciparum sporozoite challenge
  • Resident near the RUNMC, Nijmegen or agree to stay in a hotel room during the intensive period of the study (Day 5 till Day T +3)
  • Reachable by mobile phone during the whole study period
  • Availability 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

Who cannot join

  • History of malaria other than participation in EHMI-8, or residence in malaria endemic areas within the past six months
  • Plans to travel to endemic malaria areas during the study period.
  • Only for newly recruited control volunteers: previous participation in any malaria vaccine study and/or positive serology for P. falciparum
  • 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 of 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.
  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • UMC St. Radboud

    Nijmegen, 6500 HB

Other trials in Netherlands

About this study

In the EHMI-8 study (CMO 2006/207) the investigators induced sterile protection against P. falciparum challenge in healthy Dutch volunteers by repeated exposure to infected mosquitoes whilst under chloroquine prophylaxis. The surprisingly efficient induction of protection in this study strongly supports the development of whole parasite vaccines and is therefore an important finding to malaria vaccine development. In this study (EHMI8B) the investigators would like to explore the longevity of the protective immune response and simultaneously further characterise immune mechanisms responsible for protection by re-exposing EHMI-8 volunteers to infected mosquito bites.

Being tested
Exposure to 5 P. falciparum infected mosquitoes
Keywords
malaria, plasmodium, falciparum, human, experimental infection
Medical subject headings
Malaria

What participants receive

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

  • Exposure to 5 P. falciparum infected mosquitoesBiological

    Five Anopheles Stephensi mosquitoes are infected with NF54 P.falciparum. volunteers are exposed to bites for 10 minutes.

Study groups in NCT00757887
Study groupRoleWhat they receive
EHMI8ExperimentalPreviously protected volunteers, N=10
Receives: Biological: Exposure to 5 P. falciparum infected mosquitoes
controlActive comparator5 malaria-naive volunteers
Receives: Biological: Exposure to 5 P. 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 time of thick smear positivity between EHMI-8 and control volunteers

    Measured: 21 days

  2. A significant quantitative difference in parasitemia as measured by PCR between EHMI-8 and control volunteers

    Measured: 21 days

  3. A significant difference in kinetics of parasitemia between EHMI-8 and control volunteers as measured by PCR.

    Measured: 21 days

  4. A difference in occurrence of signs or symptoms between EHMI-8 and control volunteers

    Measured: 21 days

Secondary outcomes (1)

  1. Difference in immunological parameters between EHMI-8 and control volunteers.

    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 posted23 Sep 2008 (estimated)
  2. Study startOct 2009
  3. Primary completionAug 2010
  4. Study completionAug 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00757887
Sponsor's protocol ID
EHMI-8B
Status last verified
Oct 2009
First submitted
22 Sep 2008
Last updated
9 Nov 2010
Results posted
No
Data monitoring committee
Yes

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

  • Roestenberg M, Teirlinck AC, McCall MB, Teelen K, Makamdop KN, Wiersma J, Arens T, Beckers P, van Gemert G, van de Vegte-Bolmer M, van der Ven AJ, Luty AJ, Hermsen CC, Sauerwein RW. Long-term protection against malaria after experimental sporozoite inoculation: an open-label follow-up study. Lancet. 2011 May 21;377(9779):1770-6. doi: 10.1016/S0140-6736(11)60360-7. Epub 2011 Apr 22.

    PubMed 21514658

Questions about this trial

What is this clinical trial studying?

A study testing Exposure to 5 P. falciparum infected mosquitoes in people with P. Falciparum 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 13 inclusion and 23 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 time of thick smear positivity between EHMI-8 and control volunteers (time frame: 21 days). The study lists 4 primary outcomes in all. 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 NCT00757887, 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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