MalariaNCT02149550
Controlled Human Malaria Infection After Bites From Mosquitoes Infected With Two Novel P. Falciparum Strains
A study testing NF135 n=5, NF135 n=2 and NF135 n=1 in people with Malaria, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
An effective vaccine against malaria is urgently needed to combat the scourge of this disease. Before candidate vaccines can be tested in endemic countries, they are first tested in human volunteers in so-called Controlled Human Malaria Infections (CHMI's). 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?
- NF135 n=5, NF135 n=2 and NF135 n=1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesNetherlands
- Study dates
- Aug 2014to Nov 2014
- 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 strictly thereby.
- Subject is able to communicate well with the investigator, is available to attend all study visits, lives in proximity to the trial centre (<10 km) or (if >10km) is willing to stay in a hotel close to the trial centre during part of the study (day five post-infection until three days post-treatment). Furthermore the subject will remain within the Netherlands 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 and (if applicable) medical specialist 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 in the study.
- 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 current Sanquin guidelines.
- For female subjects: subject 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, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, infectious, immunodeficient, psychiatric and other disorders, 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, defined as: an estimated ten year risk of fatal cardiovascular disease of ≥5% at screening, as determined by the Systematic Coronary Risk Evaluation (SCORE); 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, even if no longer on medication.
- 1.5 Positive HIV, HBV or HCV screening tests. 1.6 Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or other 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.
- 1.7 History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years 1.8 Any history of treatment for severe psychiatric disease by a psychiatrist in the past year.
Show all 14Show fewer
- 1.9 History of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset, or positive urine toxicology test for cocaine or amphetamines at screening or prior to infection.
- For female subjects: 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 (vaccine) study.
- Known hypersensitivity to or contra-indications (including co-medication) for use of atovaquone-proguanil (Malarone®) or artemether-lumefantrine (Riamet®), or history of severe (allergic) 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, the department of Internal Medicine or Laboratory of the Havenziekenhuis or the department of Medical Microbiology \& Infectious Diseases of the Erasmus MC.
- 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
2 sites in 1 country.
About this study
Official title: Controlled Human Malaria Infection After Bites From Mosquitoes Infected With NF135.C10 or NF166.C8 Plasmodium Falciparum Parasites (BMGF2a)
An effective vaccine against malaria is urgently needed to combat the scourge of this disease. Before candidate vaccines can be tested in endemic countries, they are first tested in human volunteers in so-called Controlled Human Malaria Infections (CHMI's). Ideally, a candidate vaccine should be tested against multiple strains of malaria, representative of the disease's global distribution. Recently we compared, for the first time, infections with the novel malaria strains NF135 and NF166 to those with the broadly-used and well-characterised strain NF54.
The purpose of the current study is to optimise the course of infections with these novel strains by determining the minimum number of infectious bites necessary to reliably induce a malaria infection.
Read the detailed description
Plasmodium falciparum (Pf) malaria remains responsible for an intolerable burden of morbidity worldwide and an effective vaccine is sorely needed to aid control efforts. Before candidate malaria vaccines can enter full-scale (phase IIb) field trials in endemic areas, they must first be tested under controlled circumstances in (phase IIa) Controlled Human Malaria Infection (CHMI) studies. Since Pf isolates display a wide genetic diversity across the globe, phase IIa challenge infections should be conducted with both homologous and heterologous strains.
Since 1998 a highly successful Controlled Human Malaria Infection model at the UMC St Radboud, Nijmegen, The Netherlands, has been employed both to test candidate vaccines and to answer fundamental questions about pathophysiological and immunological mechanisms during early Pf infection in human volunteers. To date largely the NF54 strain of P. falciparum has been used in this Nijmegen model, with which extensive experience has meanwhile been acquired. In order to increase the portfolio of Pf strains available for future phase IIa studies, we recently compared NF54 to the novel candidate strains NF135.C10 and NF166.C8 with regards to parasitological, clinical and immunological characteristics during a Controlled Human Malaria Infection (TIP3 study, NCT01627951). The pre-patent period in all NF135- and NF166-infected subjects was markedly shorter than in NF54-infected subjects, following the bites of 5 infected mosquitoes on each subject. The current study will therefore assess whether NF135 and NF166 infections can still reliably be induced with fewer than 5 infected bites per subject. This will envisionably increase the tolerability of NF135 and NF166 infections and render their dynamics more similar to those of NF54 infections, for better comparison in future heterologous challenge studies.
- Conditions
- Malaria
- Being tested
- NF135 n=5, NF135 n=2, NF135 n=1, NF166 n=5, NF166 n=2
- Keywords
- Plasmodium falciparum, malaria
- 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.
NF135 n=5Other
Subjects will be infected with the NF135.C10 strain of Plasmodium falciparum through the bites of 5 infected Anopheline mosquitoes.
NF135 n=2Other
Subjects will be infected with the NF135.C10 strain of Plasmodium falciparum through the bites of 2 infected Anopheline mosquitoes.
NF135 n=1Other
Subjects will be infected with the NF135.C10 strain of Plasmodium falciparum through the bite of 1 infected Anopheline mosquito.
NF166 n=5Other
Subjects will be infected with the NF166.C8 strain of Plasmodium falciparum through the bites of 5 infected Anopheline mosquitoes.
NF166 n=2Other
Subjects will be infected with the NF166.C8 strain of Plasmodium falciparum through the bites of 2 infected Anopheline mosquitoes.
NF166 n=1Other
Subjects will be infected with the NF166.C8 strain of Plasmodium falciparum through the bite of 1 infected Anopheline mosquito.
| Study group | Role | What they receive |
|---|---|---|
| NF135 n=5 | Active comparator | Subjects will be infected with the NF135.C10 strain of Plasmodium falciparum through the bites of 5 infected Anopheline mosquitoes Receives: Other: NF135 n=5 |
| NF135 n=2 | Experimental | Subjects will be infected with the NF135.C10 strain of Plasmodium falciparum through the bites of 2 infected Anopheline mosquitoes Receives: Other: NF135 n=2 |
| NF135 n=1 | Experimental | Subjects will be infected with the NF135.C10 strain of Plasmodium falciparum through the bite of 1 infected Anopheline mosquito Receives: Other: NF135 n=1 |
| NF166 n=5 | Active comparator | Subjects will be infected with the NF166.C8 strain of Plasmodium falciparum through the bites of 5 infected Anopheline mosquitoes Receives: Other: NF166 n=5 |
| NF166 n=2 | Experimental | Subjects will be infected with the NF166.C8 strain of Plasmodium falciparum through the bites of 2 infected Anopheline mosquitoes Receives: Other: NF166 n=2 |
| NF166 n=1 | Experimental | Subjects will be infected with the NF166.C8 strain of Plasmodium falciparum through the bite of 1 infected Anopheline mosquito Receives: Other: NF166 n=1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects in each group who develop patent parasitaemia as assessed by QRT-PCR
Parasitaemia will be measured twice daily by QRT-PCR in venous whole blood, from day 5 post-infection until PCR-positive, or else until day 13 post-infection if subjects have not yet developed a positive PCR before then.
Measured: between day 5 and day 13
Secondary outcomes (3)
Time to patent parasitaemia in each group as assessed by QRT-PCR
Parasitaemia will be measured twice daily by QRT-PCR in venous whole blood, from day 5 post-infection until PCR-positive, or else until day 13 post-infection if subjects have not yet developed a positive PCR before then.
Measured: between day 5 and day 13
Magnitude of first peak of parasitaemia in each group as assessed by QRT-PCR
Parasitaemia will be measured twice daily by QRT-PCR in venous whole blood, from day 5 post-infection until PCR-positive, or else until day 13 post-infection if subjects have not yet developed a positive PCR before then.
Measured: between day 5 and day 13
Frequency of malaria-related symptoms and signs in each group
Symptoms and signs will be assessed at twice daily check-up visits from day 5 post-infection until three days after thick smear positivity, or else until day 16 post-infection, and then again on day 35-post infection.
Measured: between day 0 and day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Havenziekenhuis
- Responsible party
- Sponsor
- Investigators
- Perry van Genderen, MD, PhD, Principal investigator, Havenziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149550
- Sponsor's protocol ID
- BMGF2a
- Status last verified
- Nov 2014
- First submitted
- 26 May 2014
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McCall MBB, Wammes LJ, Langenberg MCC, van Gemert GJ, Walk J, Hermsen CC, Graumans W, Koelewijn R, Franetich JF, Chishimba S, Gerdsen M, Lorthiois A, van de Vegte M, Mazier D, Bijker EM, van Hellemond JJ, van Genderen PJJ, Sauerwein RW. Infectivity of Plasmodium falciparum sporozoites determines emerging parasitemia in infected volunteers. Sci Transl Med. 2017 Jun 21;9(395):eaag2490. doi: 10.1126/scitranslmed.aag2490.
PubMed 28637923
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Human Malaria Infection After Bites From Mosquitoes Infected With NF135.C10 or NF166.C8 Plasmodium Falciparum Parasites (BMGF2a)
- ClinicalTrials.gov ID
- NCT02149550
- Acronym / sponsor ID
- BMGF2a
- Conditions
- Malaria
- Keywords
- Plasmodium falciparum, malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Havenziekenhuis
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 29 May 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.
An effective vaccine against malaria is urgently needed to combat the scourge of this disease. Before candidate vaccines can be tested in endemic countries, they are first tested in human volunteers in so-called Controlled Human Malaria Infections (CHMI's). Ideally, a candidate vaccine should be tested against multiple strains of malaria, representative of the disease's global distribution. Recently we compared, for the first time, infections with the novel malaria strains NF135 and NF166 to those with the broadly-used and well-characterised strain NF54.
The purpose of the current study is to optimise the course of infections with these novel strains by determining the minimum number of infectious bites necessary to reliably induce a malaria infection.
Detailed description
Plasmodium falciparum (Pf) malaria remains responsible for an intolerable burden of morbidity worldwide and an effective vaccine is sorely needed to aid control efforts. Before candidate malaria vaccines can enter full-scale (phase IIb) field trials in endemic areas, they must first be tested under controlled circumstances in (phase IIa) Controlled Human Malaria Infection (CHMI) studies. Since Pf isolates display a wide genetic diversity across the globe, phase IIa challenge infections should be conducted with both homologous and heterologous strains.
Since 1998 a highly successful Controlled Human Malaria Infection model at the UMC St Radboud, Nijmegen, The Netherlands, has been employed both to test candidate vaccines and to answer fundamental questions about pathophysiological and immunological mechanisms during early Pf infection in human volunteers. To date largely the NF54 strain of P. falciparum has been used in this Nijmegen model, with which extensive experience has meanwhile been acquired. In order to increase the portfolio of Pf strains available for future phase IIa studies, we recently compared NF54 to the novel candidate strains NF135.C10 and NF166.C8 with regards to parasitological, clinical and immunological characteristics during a Controlled Human Malaria Infection (TIP3 study, NCT01627951). The pre-patent period in all NF135- and NF166-infected subjects was markedly shorter than in NF54-infected subjects, following the bites of 5 infected mosquitoes on each subject. The current study will therefore assess whether NF135 and NF166 infections can still reliably be induced with fewer than 5 infected bites per subject. This will envisionably increase the tolerability of NF135 and NF166 infections and render their dynamics more similar to those of NF54 infections, for better comparison in future heterologous challenge studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| NF135 n=5 | Active comparator | Other: NF135 n=5Subjects will be infected with the NF135.C10 strain of Plasmodium falciparum through the bites of 5 infected Anopheline mosquitoes |
| NF135 n=2 | Experimental | Other: NF135 n=2Subjects will be infected with the NF135.C10 strain of Plasmodium falciparum through the bites of 2 infected Anopheline mosquitoes |
| NF135 n=1 | Experimental | Other: NF135 n=1Subjects will be infected with the NF135.C10 strain of Plasmodium falciparum through the bite of 1 infected Anopheline mosquito |
| NF166 n=5 | Active comparator | Other: NF166 n=5Subjects will be infected with the NF166.C8 strain of Plasmodium falciparum through the bites of 5 infected Anopheline mosquitoes |
| NF166 n=2 | Experimental | Other: NF166 n=2Subjects will be infected with the NF166.C8 strain of Plasmodium falciparum through the bites of 2 infected Anopheline mosquitoes |
| NF166 n=1 | Experimental | Other: NF166 n=1Subjects will be infected with the NF166.C8 strain of Plasmodium falciparum through the bite of 1 infected Anopheline mosquito |
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 strictly thereby.
- Subject is able to communicate well with the investigator, is available to attend all study visits, lives in proximity to the trial centre (<10 km) or (if >10km) is willing to stay in a hotel close to the trial centre during part of the study (day five post-infection until three days post-treatment). Furthermore the subject will remain within the Netherlands 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 and (if applicable) medical specialist 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 in the study.
- 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 current Sanquin guidelines.
Key exclusion criteria (14 listed)
- Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, infectious, immunodeficient, psychiatric and other disorders, 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, defined as: an estimated ten year risk of fatal cardiovascular disease of ≥5% at screening, as determined by the Systematic Coronary Risk Evaluation (SCORE); 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, even if no longer on medication.
- 1.5 Positive HIV, HBV or HCV screening tests. 1.6 Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or other 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.
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 |
|---|---|---|
| NF135 n=5Subjects will be infected with the NF135.C10 strain of Plasmodium falciparum through the bites of 5 infected Anopheline mosquitoes. | Other | NF135 n=5 |
| NF135 n=2Subjects will be infected with the NF135.C10 strain of Plasmodium falciparum through the bites of 2 infected Anopheline mosquitoes. | Other | NF135 n=2 |
| NF135 n=1Subjects will be infected with the NF135.C10 strain of Plasmodium falciparum through the bite of 1 infected Anopheline mosquito. | Other | NF135 n=1 |
| NF166 n=5Subjects will be infected with the NF166.C8 strain of Plasmodium falciparum through the bites of 5 infected Anopheline mosquitoes. | Other | NF166 n=5 |
| NF166 n=2Subjects will be infected with the NF166.C8 strain of Plasmodium falciparum through the bites of 2 infected Anopheline mosquitoes. | Other | NF166 n=2 |
| NF166 n=1Subjects will be infected with the NF166.C8 strain of Plasmodium falciparum through the bite of 1 infected Anopheline mosquito. | Other | NF166 n=1 |
Primary outcome
Proportion of subjects in each group who develop patent parasitaemia as assessed by QRT-PCR
Time frame: between day 5 and day 13
Parasitaemia will be measured twice daily by QRT-PCR in venous whole blood, from day 5 post-infection until PCR-positive, or else until day 13 post-infection if subjects have not yet developed a positive PCR before then.
3 secondary outcomes
Time to patent parasitaemia in each group as assessed by QRT-PCR
Time frame: between day 5 and day 13
Magnitude of first peak of parasitaemia in each group as assessed by QRT-PCR
Time frame: between day 5 and day 13
Frequency of malaria-related symptoms and signs in each group
Time frame: between day 0 and day 35
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 24 Nov 2014.
- Derived from this study: PubMed 28637923McCall MBB, Wammes LJ, Langenberg MCC, van Gemert GJ, Walk J, Hermsen CC, Graumans W, Koelewijn R, Franetich JF, Chishimba S, Gerdsen M, Lorthiois A, van de Vegte M, Mazier D, Bijker EM, van Hellemond JJ, van Genderen PJJ, Sauerwein RW. Infectivity of Plasmodium falciparum sporozoites determines emerging parasitemia in infected volunteers. Sci Transl Med. 2017 Jun 21;9(395):eaag2490. doi: 10.1126/scitranslmed.aag2490.
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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.
Perry van Genderen, MD, PhD principal investigator
Havenziekenhuis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NF135 n=5, NF135 n=2 and NF135 n=1 in people with Malaria, run by Radboud University Medical Center at 2 sites 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 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Proportion of subjects in each group who develop patent parasitaemia as assessed by QRT-PCR (time frame: between day 5 and day 13). 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 NCT02149550, which also lists 1 linked publication.
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 24 Nov 2014.