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CompletedNCT00757887Updated Nov 9, 2010

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

An interventional study of Exposure to 5 P. falciparum infected mosquitoes in P. Falciparum Malaria, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-11-09.

Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • P. Falciparum Malaria

Keywords

  • malaria
  • plasmodium
  • falciparum
  • human
  • experimental infection
03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's planned enrollment of 15 is below the median of 220 across 1,027 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age > 18 and \< 35 years healthy volunteers (males or females).
  2. General good health based on history and clinical examination.
  3. Negative pregnancy test.
  4. Use of adequate contraception for females
  5. All volunteers have to sign the informed consent form following proper understanding of the meaning and procedures of the study
  6. Volunteer agrees to inform the general practitioner and agrees to sign a request for medical information concerning contra-indications for participation in the study
  7. Willingness to undergo a P. falciparum sporozoite challenge
  8. 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)
  9. Reachable by mobile phone during the whole study period
  10. Availability to attend all study visits
  11. Agreement to refrain from blood donation to Sanquin or for other purposes, during the course of the study
  12. Willingness to undergo an HIV, hepatitis B and C test
  13. Negative urine toxicology screening test at screening visit and day before challenge

Exclusion criteria

Exclusion criteria

  1. History of malaria other than participation in EHMI-8, or residence in malaria endemic areas within the past six months
  2. Plans to travel to endemic malaria areas during the study period.
  3. Only for newly recruited control volunteers: previous participation in any malaria vaccine study and/or positive serology for P. falciparum
  4. 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.
  5. History of diabetes mellitus or cancer (except basal cell carcinoma of the skin)
  6. History of arrhythmia's or prolonged QT-interval
  7. Positive family history in 1st and 2nd degree relatives of cardiac disease \< 50 years old
  8. An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system.
  9. Any clinically significant deviation from the normal range in biochemistry or haematology blood tests or in urine analysis
  10. Positive HIV, HBV or HCV tests
  11. Participation in any other clinical study within 30 days prior to the onset of the study
  12. Volunteers enrolled in any other clinical study during the study period
  13. Pregnant or lactating women
  14. Volunteers unable to give written informed consent
  15. Volunteers unable to be closely followed for social, geographic or psychological reasons
  16. Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study
  17. A history of psychiatric disease
  18. Known hypersensitivity for anti-malaria drugs
  19. History of severe reactions or allergy to mosquito bites
  20. 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
  21. Contra-indications to Malarone® including treatment taken by the volunteers that interfere with Malarone®
  22. Any confirmed or suspected immunosuppressive or immunodeficiency condition, including asplenia
  23. Co-workers of the departments of Medical Microbiology or Internal Medicine of the Radboud University Nijmegen Medical Centre
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    EHMI8

    Previously protected volunteers, N=10

    Biological: Exposure to 5 P. falciparum infected mosquitoes

  • Active comparator
    control

    5 malaria-naive volunteers

    Biological: Exposure to 5 P. falciparum infected mosquitoes

Interventions

  • BiologicalExposure to 5 P. falciparum infected mosquitoes

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

06

What researchers measure

Primary outcomes

  1. A significant difference in time of thick smear positivity between EHMI-8 and control volunteers

    Time frame: 21 days

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

    Time frame: 21 days

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

    Time frame: 21 days

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

    Time frame: 21 days

Secondary outcomes

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

    Time frame: 140 days

07

Study locations

1 site
  • UMC St. Radboud
    Nijmegen, 6500 HB, Netherlands
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00757887
Lead sponsor
Radboud University Medical Center
First posted
Sep 23, 2008
Start date
Oct 2009
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Nov 9, 2010

Study contacts

Robert Sauerwein, Prof. Dr.
principal investigator · Radboud University Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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