MalariaBMGF1NCT02080026
Target Antigens Induced by Plasmodium Falciparum Sporozoite Immunization Under Chemoprophylaxis
A study testing CPS-immunization, chloroquine and atovaquone/proguanil in people with Malaria, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Malaria, a disease caused by the parasite Plasmodium, is one of the world's major infectious diseases. With approximately 627.000 deaths a year, there is desperate need for an effective vaccine. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- CPS-immunization, chloroquine and atovaquone/proguanil
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2014to Jul 2015
- 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
- Subject is aged ≥ 18 and ≤ 35 years and in good health.
- Subject has adequate understanding of the procedures of the study and agrees to abide thereby.
- Subject is able to communicate well with the investigator, is available to attend all study visits, lives in proximity to the trial centre or is willing to stay in a hotel close to the trial centre during part of the study (day 5 post-infection until three days post-treatment). The subject will remain within the Netherlands during the challenge period, not travel to a malaria-endemic area during the study period, and is reachable (24/7) by mobile telephone throughout the entire study period.
- Subject agrees to inform his/her general practitioner (GP) about participation in the study and to sign a request to release by the GP any relevant medical information concerning possible contra-indications for participation.
- Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period and for a defined period thereafter according to Sanquin guidelines.
- For female subjects: agrees to use adequate contraception and not to breastfeed for the duration of study.
- Subject has signed informed consent.
Who cannot join
- Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following:
- 1.1 Body weight <50 kg or Body Mass Index (BMI) <18.0 or >30.0 kg/m2 at screening.
- 1.2 A heightened risk of cardiovascular disease, as determined by: an estimated ten year risk of fatal cardiovascular disease of ≥5% at screening, as determined by the Systematic Coronary Risk Evaluation; history, or evidence at screening, of clinically significant arrhythmia's, prolonged QT-interval or other clinically relevant ECG abnormalities; or a positive family history of cardiac events in 1st or 2nd degree relatives <50 years old.
- 1.3 Functional asplenia, sickle cell trait/disease, thalassaemia trait/disease or G6PD deficiency.
- 1.4 History of epilepsy in the period of five years prior to study onset. 1.5 Positive Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) screening tests.
- 1.6 Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period.
Show all 15Show fewer
- 1.7 History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, in the past 5 years.
- 1.8 Any history of treatment for severe psychiatric disease in the past year. 1.9 History of drug or alcohol abuse one year prior to study onset, or positive urine toxicology test for cocaine or amphetamines at screening or prior to infection.
- Females: positive urine pregnancy test at screening or prior to infection.
- Any history of malaria, positive serology for P. falciparum, or previous participation in any malaria study.
- Known hypersensitivity to or contra-indications to any antimalarials, or history of severe reactions to mosquito bites.
- Receipt of any vaccinations in the 3 months prior to the start of the study or plans to receive any other vaccinations during the study period or up to 8 weeks thereafter.
- Participation in any other clinical study in the 30 days prior to the start of the study or during the study period.
- Being an employee or student of the department of Medical Microbiology of the Radboudumc or the department of Internal Medicine.
- Any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6525 GA
About this study
Official title: Identification of Pre-erythrocytic Target Antigens Induced by Plasmodium Falciparum Sporozoite Immunization Under Chemoprophylaxis
Malaria, a disease caused by the parasite Plasmodium, is one of the world's major infectious diseases. With approximately 627.000 deaths a year, there is desperate need for an effective vaccine. Though a number of vaccine-candidates have been developed, they have yet to achieve the level of efficacy necessary to eliminate malaria. It has been shown previously that healthy human volunteers bitten by malaria-infected mosquitoes while taking chloroquine, medicine that prevents malaria, are fully protected against a subsequent malaria challenge. This is called CPS-immunization. The unprecedented effectiveness of CPS-immunization makes it a good model to identify what immune responses protect against malaria, to further guide vaccine development. In this study we will use CPS-immunization to induce protection against malaria in healthy subjects and then analyse their immune response to a malaria challenge infection.
Read the detailed description
Rationale:
Malaria, a disease caused by the parasite Plasmodium, is one of the world's major infectious diseases. With approximately 627.000 deaths a year, it is both a chief cause of morbidity and mortality as well as a significant contribution to ongoing poverty in endemic countries. Ultimately, the key to malaria control and hopefully eradication, would be an effective vaccine. Though a number of vaccine-candidates have entered the pipeline of pre-clinical and clinical development, they have yet to achieve the level of efficacy necessary for effective malaria prevention. It has been shown previously that healthy human volunteers can be fully protected against malaria infection with a homologous parasite by immunization with Plasmodium parasites while taking chloroquine chemoprophylaxis (ChemoProphylaxis and Sporozoites, CPS-immunization). The unprecedented efficacy of CPS-immunization makes it a unique model to identify pre-erythrocytic target antigens for the development of a subunit vaccine. Identification of antigens that play a significant role in the development of sterile protection against malaria will provide a basis for the development and evaluation of more effective sub-unit candidate vaccines.
Primary objective:
- To delineate the antibody repertoire directed against the pre-erythrocytic stages of Plasmodium falciparum induced by CPS-immunization.
Secondary objectives:
- To assess the functionality of CPS-immunization induced antibodies.
- To determine T-cell antigen specificities in CPS-immunized, protected volunteers.
Exploratory objectives:
- To assess the functionality of CPS-immunization induced T-cells.
- To explore the adaptive and innate immune responses during CPS-immunization and early malaria infection.
Study design:
This is a single-centre, randomized open-label study. A total of 15 volunteers will be divided into two groups, one scheduled to receive CPS immunization (Group 1, n=10) and one to receive only chloroquine prior to malaria challenge (Group 2, n=5).
Study population:
The study population will be comprised of male and female healthy subjects. A total of 15 subjects will be enrolled to participate in the study and randomized.
Intervention:
In the immunization group a total of four CPS immunizations will be performed, with 15 bites from Plasmodium infected mosquitoes per immunization, over a period of four months, during which volunteers will take chloroquine prophylaxis. The control group will take only chloroquine prophylaxis during this period. All volunteers will undergo Controlled Human Malaria Infection (CHMI) by exposure to 5 bites from Plasmodium falciparum sporozoite infected mosquitoes.
- Conditions
- Malaria
- Being tested
- CPS-immunization, Controlled Human Malaria Infection, chloroquine, atovaquone/proguanil
- Keywords
- malaria, Plasmodium falciparum
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPS-immunizationBiological
Also called Plasmodium falciparum NF54 infected Anopheles mosquitoes, Chloroquine
Subjects will receive four 'immunizations' with bites from 15 Plasmodium infected mosquitoes during each immunization, while taking chloroquine prophylaxis.
Controlled Human Malaria InfectionBiological
Also called Plasmodium falciparum NF54 infected Anopheles mosquitoes
Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum, NF54 strain.
chloroquineDrug
Registered for prophylaxis against infection with Plasmodium falciparum and the treatment of acute infections.
atovaquone/proguanilDrug
Also called Malarone
Registered for use as an antimalarial agent for the treatment of acute infections with Plasmodium falciparum.
One tablet contains: atovaquone 250 mg, proguanil(hydrochloride) 100 mg
| Study group | Role | What they receive |
|---|---|---|
| CPS-immunization | Experimental | In this group a total of four CPS-immunizations will be performed, with bites from 15 Plasmodium infected mosquitoes per immunization, over a period of four months, during which volunteers will take chloroquine prophylaxis.
14 weeks after the last immunization, these volunteers will undergo Controlled Human Malaria Infection (CHMI) by exposure to bites from 5 Plasmodium falciparum sporozoite infected mosquitoes.
If a subject develops a malaria infection he/she will be treated with atovaquone/proguanil (Malarone). At the end of the study any subjects that did not develop a malaria infection will also be treated with atovaquone/proguanil (Malarone). Receives: Biological: CPS-immunization; Biological: Controlled Human Malaria Infection; Drug: atovaquone/proguanil |
| Control | Other | This group will take chloroquine prophylaxis during the same period as the immunization group, but will not receive CPS-immunizations.
10 weeks after stopping chloroquine prophylaxis, these volunteers will undergo Controlled Human Malaria Infection (CHMI) by exposure to bites from 5 Plasmodium falciparum sporozoite infected mosquitoes.
If a subject develops a malaria infection he/she will be treated with atovaquone/proguanil (Malarone). At the end of the study any subjects that did not develop a malaria infection will also be treated with atovaquone/proguanil (Malarone). Receives: Biological: Controlled Human Malaria Infection; Drug: chloroquine; Drug: atovaquone/proguanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation of B-cells for delineation of antibody responses against Plasmodium falciparum pre-erythrocytic stages in CPS-immunized, protected volunteers.
After immunization and Controlled Human Malaria Infection (CHMI) blood will be drawn to isolate plasmablast for further delineation of the antibody responses following CPS-immunization.
Measured: On day 232-238 of the study (6-11 days after challenge malaria infection)
Secondary outcomes (2)
Functionality of CPS-immunization induced antibodies for protection against pre-erythrocytic stages of Plasmodium falciparum.
On day 107 and day 142 of the study (14 days after the 3rd CPS-immunization and 14 days after the 4th immunization) blood will be drawn for IgG isolation, which will be used to determine the functionality of these antibodies against the pre-erythrocytic stages of Plasmodium falciparum.
Measured: On day 107 and day 142 of the study (14 days after the 3rd CPS-immunization and 14 days after the 4th immunization)
The specificity of CPS-immunization induced T-cell responses against pre-erythrocytic stages of Plasmodium falciparum.
Before the first immunization and six weeks after the malaria challenge infection leukapheresis will be performed to isolate T-cells, which will be used to determine the activity of T-cells against specific target antigens of the pre-erythrocytic stages of Plasmodium falciparum.
Measured: On day 1-14 and on day 267-280 of the study (before the first immunization and after Controlled Human Malaria Infection (CHMI))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2015
- Study completionJul 2015
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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Robert W Sauerwein, Prof., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080026
- Sponsor's protocol ID
- BMGF1
- Other IDs
- NL48301.091.14
- Acronym
- BMGF1
- Status last verified
- Aug 2015
- First submitted
- 4 Mar 2014
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 19641203Roestenberg M, O'Hara GA, Duncan CJ, Epstein JE, Edwards NJ, Scholzen A, van der Ven AJ, Hermsen CC, Hill AV, Sauerwein RW. Comparison of clinical and parasitological data from controlled human malaria infection trials. PLoS One. 2012;7(6):e38434. doi: 10.1371/journal.pone.0038434. Epub 2012 Jun 11.
PubMed 22701640
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Pre-erythrocytic Target Antigens Induced by Plasmodium Falciparum Sporozoite Immunization Under Chemoprophylaxis
- ClinicalTrials.gov ID
- NCT02080026
- Acronym / sponsor ID
- BMGF1 / BMGF1
- Conditions
- Malaria
- Keywords
- malaria, Plasmodium falciparum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Jun 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 Mar 2014 (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.
Malaria, a disease caused by the parasite Plasmodium, is one of the world's major infectious diseases. With approximately 627.000 deaths a year, there is desperate need for an effective vaccine. Though a number of vaccine-candidates have been developed, they have yet to achieve the level of efficacy necessary to eliminate malaria. It has been shown previously that healthy human volunteers bitten by malaria-infected mosquitoes while taking chloroquine, medicine that prevents malaria, are fully protected against a subsequent malaria challenge. This is called CPS-immunization. The unprecedented effectiveness of CPS-immunization makes it a good model to identify what immune responses protect against malaria, to further guide vaccine development. In this study we will use CPS-immunization to induce protection against malaria in healthy subjects and then analyse their immune response to a malaria challenge infection.
Detailed description
Rationale:
Malaria, a disease caused by the parasite Plasmodium, is one of the world's major infectious diseases. With approximately 627.000 deaths a year, it is both a chief cause of morbidity and mortality as well as a significant contribution to ongoing poverty in endemic countries. Ultimately, the key to malaria control and hopefully eradication, would be an effective vaccine. Though a number of vaccine-candidates have entered the pipeline of pre-clinical and clinical development, they have yet to achieve the level of efficacy necessary for effective malaria prevention. It has been shown previously that healthy human volunteers can be fully protected against malaria infection with a homologous parasite by immunization with Plasmodium parasites while taking chloroquine chemoprophylaxis (ChemoProphylaxis and Sporozoites, CPS-immunization). The unprecedented efficacy of CPS-immunization makes it a unique model to identify pre-erythrocytic target antigens for the development of a subunit vaccine. Identification of antigens that play a significant role in the development of sterile protection against malaria will provide a basis for the development and evaluation of more effective sub-unit candidate vaccines.
Primary objective:
- To delineate the antibody repertoire directed against the pre-erythrocytic stages of Plasmodium falciparum induced by CPS-immunization.
Secondary objectives:
- To assess the functionality of CPS-immunization induced antibodies.
- To determine T-cell antigen specificities in CPS-immunized, protected volunteers.
Exploratory objectives:
- To assess the functionality of CPS-immunization induced T-cells.
- To explore the adaptive and innate immune responses during CPS-immunization and early malaria infection.
Study design:
This is a single-centre, randomized open-label study. A total of 15 volunteers will be divided into two groups, one scheduled to receive CPS immunization (Group 1, n=10) and one to receive only chloroquine prior to malaria challenge (Group 2, n=5).
Study population:
The study population will be comprised of male and female healthy subjects. A total of 15 subjects will be enrolled to participate in the study and randomized.
Intervention:
In the immunization group a total of four CPS immunizations will be performed, with 15 bites from Plasmodium infected mosquitoes per immunization, over a period of four months, during which volunteers will take chloroquine prophylaxis. The control group will take only chloroquine prophylaxis during this period. All volunteers will undergo Controlled Human Malaria Infection (CHMI) by exposure to 5 bites from Plasmodium falciparum sporozoite infected mosquitoes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPS-immunization | Experimental | Biological: CPS-immunization, Biological: Controlled Human Malaria Infection, Drug: atovaquone/proguanilIn this group a total of four CPS-immunizations will be performed, with bites from 15 Plasmodium infected mosquitoes per immunization, over a period of four months, during which volunteers will take chloroquine prophylaxis. 14 weeks after the last immunization, these volunteers will undergo Controlled Human Malaria Infection (CHMI) by exposure to bites from 5 Plasmodium falciparum sporozoite infected mosquitoes. If a subject develops a malaria infection he/she will be treated with atovaquone/proguanil (Malarone). At the end of the study any subjects that did not develop a malaria infection will also be treated with atovaquone/proguanil (Malarone). |
| Control | Other | Biological: Controlled Human Malaria Infection, Drug: chloroquine, Drug: atovaquone/proguanilThis group will take chloroquine prophylaxis during the same period as the immunization group, but will not receive CPS-immunizations. 10 weeks after stopping chloroquine prophylaxis, these volunteers will undergo Controlled Human Malaria Infection (CHMI) by exposure to bites from 5 Plasmodium falciparum sporozoite infected mosquitoes. If a subject develops a malaria infection he/she will be treated with atovaquone/proguanil (Malarone). At the end of the study any subjects that did not develop a malaria infection will also be treated with atovaquone/proguanil (Malarone). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is aged ≥ 18 and ≤ 35 years and in good health.
- Subject has adequate understanding of the procedures of the study and agrees to abide thereby.
- Subject is able to communicate well with the investigator, is available to attend all study visits, lives in proximity to the trial centre or is willing to stay in a hotel close to the trial centre during part of the study (day 5 post-infection until three days post-treatment). The subject will remain within the Netherlands during the challenge period, not travel to a malaria-endemic area during the study period, and is reachable (24/7) by mobile telephone throughout the entire study period.
- Subject agrees to inform his/her general practitioner (GP) about participation in the study and to sign a request to release by the GP any relevant medical information concerning possible contra-indications for participation.
- Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period and for a defined period thereafter according to Sanquin guidelines.
Key exclusion criteria (15 listed)
- Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following:
- 1.1 Body weight <50 kg or Body Mass Index (BMI) <18.0 or >30.0 kg/m2 at screening.
- 1.2 A heightened risk of cardiovascular disease, as determined by: an estimated ten year risk of fatal cardiovascular disease of ≥5% at screening, as determined by the Systematic Coronary Risk Evaluation; history, or evidence at screening, of clinically significant arrhythmia's, prolonged QT-interval or other clinically relevant ECG abnormalities; or a positive family history of cardiac events in 1st or 2nd degree relatives <50 years old.
- 1.3 Functional asplenia, sickle cell trait/disease, thalassaemia trait/disease or G6PD deficiency.
- 1.4 History of epilepsy in the period of five years prior to study onset. 1.5 Positive Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) screening tests.
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 |
|---|---|---|
| CPS-immunizationAlso: Plasmodium falciparum NF54 infected Anopheles mosquitoes, ChloroquineSubjects will receive four 'immunizations' with bites from 15 Plasmodium infected mosquitoes during each immunization, while taking chloroquine prophylaxis. | Biological | CPS-immunization |
| Controlled Human Malaria InfectionAlso: Plasmodium falciparum NF54 infected Anopheles mosquitoesSubjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum, NF54 strain. | Biological | CPS-immunization, Control |
| chloroquineRegistered for prophylaxis against infection with Plasmodium falciparum and the treatment of acute infections. | Drug | Control |
| atovaquone/proguanilAlso: MalaroneRegistered for use as an antimalarial agent for the treatment of acute infections with Plasmodium falciparum. One tablet contains: atovaquone 250 mg, proguanil(hydrochloride) 100 mg | Drug | CPS-immunization, Control |
Primary outcome
Generation of B-cells for delineation of antibody responses against Plasmodium falciparum pre-erythrocytic stages in CPS-immunized, protected volunteers.
Time frame: On day 232-238 of the study (6-11 days after challenge malaria infection)
After immunization and Controlled Human Malaria Infection (CHMI) blood will be drawn to isolate plasmablast for further delineation of the antibody responses following CPS-immunization.
2 secondary outcomes
Functionality of CPS-immunization induced antibodies for protection against pre-erythrocytic stages of Plasmodium falciparum.
Time frame: On day 107 and day 142 of the study (14 days after the 3rd CPS-immunization and 14 days after the 4th immunization)
The specificity of CPS-immunization induced T-cell responses against pre-erythrocytic stages of Plasmodium falciparum.
Time frame: On day 1-14 and on day 267-280 of the study (before the first immunization and after Controlled Human Malaria Infection (CHMI))
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 10 Aug 2015.
- Background: 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.
- Background: PubMed 22701640Roestenberg M, O'Hara GA, Duncan CJ, Epstein JE, Edwards NJ, Scholzen A, van der Ven AJ, Hermsen CC, Hill AV, Sauerwein RW. Comparison of clinical and parasitological data from controlled human malaria infection trials. PLoS One. 2012;7(6):e38434. doi: 10.1371/journal.pone.0038434. Epub 2012 Jun 11.
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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 W 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 CPS-immunization, chloroquine and atovaquone/proguanil in people with 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 15 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 10 Aug 2015. 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?
Generation of B-cells for delineation of antibody responses against Plasmodium falciparum pre-erythrocytic stages in CPS-immunized, protected volunteers. (time frame: On day 232-238 of the study (6-11 days after challenge malaria infection)). 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 NCT02080026, 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 10 Aug 2015; AzTrials last refreshed its copy on 8 Nov 2026.