Falciparum MalariaNCT00442377
Study to Investigate the Induction of an Protective Immune Response to Malaria
A study testing exposure to malaria sporozoites in people with Falciparum Malaria, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Falciparum Malaria
- What is being tested?
- exposure to malaria sporozoites
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2007to Jul 2007
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
About this study
Official title: Exposure of Human Volunteers to Live Malaria Sporozoites Under Chloroquine Prophylaxis
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.
- Conditions
- Falciparum Malaria
- Being tested
- exposure to malaria sporozoites
- Keywords
- Falciparum, Plasmodium, 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 malaria sporozoitesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
A significant difference in time of thick smear positivity between exposed and control groups
A significant difference in parasitemia as measured by 18S Pf NASBA between exposed and control group
A significant difference in kinetics of parasitemia between exposed and control groups as measured by 18S Pf NASBA.
A difference in occurrence or height of fever between exposed and control groups.
Secondary outcomes (6)
Significant differences in immune response between exposed and control volunteers (including NK-cell reactivity, TLR reactivity and regulatory T-cell reactivity)
Significant differences in the outcome of in vitro functional malaria assays between exposed and control volunteers
Significant differences in cellular reactivity against Pf antigens
Significant differences in parasite VAR gene expression during infection
The identification of immune mechanisms that correlate with protection
6. The identification of potential vaccine candidates that correlate with protection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startJan 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Falciparum MalariaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Robert Sauerwein, Prof, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442377
- Sponsor's protocol ID
- EHMI-8
- Status last verified
- Aug 2007
- First submitted
- 28 Feb 2007
- Last updated
- 16 Aug 2007
- Results posted
- 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 28081133Roestenberg 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure of Human Volunteers to Live Malaria Sporozoites Under Chloroquine Prophylaxis
- ClinicalTrials.gov ID
- NCT00442377
- Acronym / sponsor ID
- EHMI-8
- Conditions
- Falciparum Malaria
- Keywords
- Falciparum, Plasmodium, Malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Jul 2007 (actual)
- First posted
- 1 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exposure to malaria sporozoites | Procedure or surgery | – |
Primary outcome
A significant difference in time of thick smear positivity between exposed and control groups
A significant difference in parasitemia as measured by 18S Pf NASBA between exposed and control group
A significant difference in kinetics of parasitemia between exposed and control groups as measured by 18S Pf NASBA.
A difference in occurrence or height of fever between exposed and control groups.
6 secondary outcomes
Significant differences in immune response between exposed and control volunteers (including NK-cell reactivity, TLR reactivity and regulatory T-cell reactivity)
Significant differences in the outcome of in vitro functional malaria assays between exposed and control volunteers
Significant differences in cellular reactivity against Pf antigens
Significant differences in parasite VAR gene expression during infection
The identification of immune mechanisms that correlate with protection
6. The identification of potential vaccine candidates that correlate with protection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2007.
- Derived from this study: PubMed 28081133Coffeng 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.
- Derived from this study: PubMed 19641203Roestenberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Sauerwein, Prof principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exposure to malaria sporozoites in people with 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 7 inclusion and 14 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 16 Aug 2007. 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 exposed and control groups. 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 NCT00442377, 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 16 Aug 2007.