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CompletedNCT00442377Updated Aug 16, 2007

Study to Investigate the Induction of an Protective Immune Response to Malaria

An interventional study of exposure to malaria sporozoites in Falciparum Malaria, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-08-16.

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

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The objective of the study is to induce a protective immune response against malaria in healthy human volunteers. The different parts of the immune response will then be studied.

Read the detailed description

Efforts to develop vaccines against malaria still represent a substantial focus of current research activities. Factors that have hampered the development of a subunit vaccine include the complexity of the malaria life cycle, the wide variety of immune response induced by the malaria parasite, and an incomplete knowledge of protective immunity. This study is therefore aimed at inducing protective immunity against malaria in 15 healthy volunteers. Volunteers will be exposed to the bites of infectious mosquitoes 3 times with live P. falciparum sporozoites under chloroquine prophylaxis. Challenge with infected mosquitoes will be given after stopping chloroquine prophylaxis.

Five volunteers will form a control group; they will be exposed to non-infectious mosquitoes under chloroquine prophylaxis.

Endpoints include the time and height of parasitemia after challenge, the development of fever and immunological parameters.

02

Conditions studied

  • Falciparum Malaria

Keywords

  • Falciparum
  • Plasmodium
  • Malaria
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 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age > 18 and \< 45 years healthy volunteers (males or females).
  • General good health based on history and clinical examination.
  • All volunteers have to sign the informed consent form.
  • Negative pregnancy test.
  • Use of adequate contraception for females
  • Reachable by phone during the whole study period.
  • Volunteer agrees to inform the general practitioner and agrees to sign a request for medical information concerning contra-indications for participation in the trial

Exclusion criteria

Exclusion Criteria:

  • History of malaria or residence in malaria endemic areas within the past six months.
  • Positive serology for P. falciparum
  • Previously participated in any malaria vaccine study
  • 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.
  • Cardiovascular risk >10% according to European guidelines, taking into account sex, age, cholesterol, weight, smoking habits, blood pressure, diabetes
  • Any laboratory abnormalities on screened blood samples beyond the normal range, as defined at UMC St Radboud. Positive HIV, HBV or HCV tests.
  • Volunteers should not be enrolled in any other clinical trial during the whole trial period.
  • Volunteers should not receive chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the three months preceding the screening visit or 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.
  • Known hypersensitivity for anti-malaria drugs
  • Volunteers are not allowed to travel to malaria endemic countries during the study period.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
15 participants (estimated)

Interventions

  • Procedureexposure to malaria sporozoites
06

What researchers measure

Primary outcomes

  1. A significant difference in time of thick smear positivity between exposed and control groups

  2. A significant difference in parasitemia as measured by 18S Pf NASBA between exposed and control group

  3. A significant difference in kinetics of parasitemia between exposed and control groups as measured by 18S Pf NASBA.

  4. A difference in occurrence or height of fever between exposed and control groups.

Secondary outcomes

  1. Significant differences in immune response between exposed and control volunteers (including NK-cell reactivity, TLR reactivity and regulatory T-cell reactivity)

  2. Significant differences in the outcome of in vitro functional malaria assays between exposed and control volunteers

  3. Significant differences in cellular reactivity against Pf antigens

  4. Significant differences in parasite VAR gene expression during infection

  5. The identification of immune mechanisms that correlate with protection

  6. 6. The identification of potential vaccine candidates that correlate with protection

07

Study locations

1 site
  • Radboud University Nijmegen Medical Centre
    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, McCall M, Hopman J, Wiersma J, Luty AJ, van Gemert GJ, van de Vegte-Bolmer M, van Schaijk B, Teelen K, Arens T, Spaarman L, de Mast Q, Roeffen W, Snounou G, Renia L, van der Ven A, Hermsen CC, Sauerwein R. Protection against a malaria challenge by sporozoite inoculation. N Engl J Med. 2009 Jul 30;361(5):468-77. doi: 10.1056/NEJMoa0805832. PubMed 19641203 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00442377
Lead sponsor
Radboud University Medical Center
First posted
Mar 1, 2007
Start date
Jan 2007
Completion
Jul 2007
Last update
Aug 16, 2007

Study contacts

Robert Sauerwein, Prof
principal investigator · Radboud University Medical Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.

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