Malaria,FalciparumEarly Phase 1CoGANCT05468606
Coadministration of GA2 Sporozoites With Adjuvants
A Early Phase 1 study testing GA2, BCG and YF-17D (fractional ID dose) in people with Malaria,Falciparum, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
This study will assess the coadministration of genetically attenuated Plasmodium falciparum ∆mei2 (GA2) sporozoites with adjuvants (BCG and YF-17D vaccination and imiquimod cream). Primary outcomes will be safety, tolerability and protective efficacy against CHMI. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- GA2, BCG and YF-17D (fractional ID dose)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Feb 2023to Dec 2024
- Phase
- Early Phase 1
- 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
- Participant is aged ≥18 and ≤35 years and in good health.
- Participant has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
- Participant is able to communicate well with the investigator
- Participant is available to attend all essential study visits.
- Participant agrees that his/her general practitioner (GP) will be informed about participation in the study.
- Participant agrees to refrain from blood donation to the national blood bank or for other purposes throughout the study period and for a defined period thereafter according to national blood bank guidelines.
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- Participants of child bearing potential (i.e., have an uterus and are neither surgically sterilized nor post-menopausal) agree to use adequate contraception and to not breastfeed for the duration of study.
- Participant agrees to refrain from intensive physical exercise (disproportionate to the participants' usual daily activity or exercise routine) for twenty-one days following the immunization and during the malaria challenge period.
- Participant signs informed consent.
Who cannot join
- 1. 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 participant during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following:
- Body Mass Index (BMI) >35.0 kg/m2 at screening. b. An elevated risk of cardiovascular disease, defined as: i. An estimated ten-year risk of fatal cardiovascular disease of ≥5% at screening, as determined by the Systematic Coronary Risk Evaluation 2 (SCORE2) .
- History, or evidence at screening, of clinically significant arrhythmia's, prolonged QT-interval or other clinically relevant ECG abnormalities; or iii. A positive family history of cardiac events in first- or second-degree relatives (according to the system used in medical genetics) <50 years old.
- Known functional asplenia, sickle cell trait/disease, thalassemia trait/disease or G6PD deficiency.
- History of epilepsy in the period of five years prior to study onset, even if no longer on medication.
- Positive HIV, HBV or HCV screening tests. f. Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or other drugs that might have an influence on the immune system (excluding inhaled and topical corticosteroids and incidental use of oral anti-histamines), within three months prior to study onset or expected use of such during the study period.
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- Skin disease affecting the site of administration in such a way that administration of mosquito bites or adjuvants is deemed impossible by investigator.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past five years.
- Any history of treatment for severe psychiatric disease by a psychiatrist in the past year.
- History of drug or alcohol abuse interfering with normal social functioning in the period of one year prior to study onset, positive urine toxicology test for cocaine or amphetamines at screening.
- 2. For participants of child bearing potential: breastfeeding, or positive urine pregnancy test prior to immunization or prior to CHMI.
- 3. Any history of malaria or previous participation in any malaria (vaccine) study or CHMI.
- 4. Known hypersensitivity to or contra-indications for both atovaquone/proguanil or artemether/lumefantrine. QT prolonging drugs are only considered an exclusion criterion when QT prolongation is observed at the ECG at screening.
- 5. A history of severe (allergic) reactions to mosquito bites. 6. Any history of infection with mycobacteria or BCG vaccination (only in stage B and C) 7. Any history of infection with yellow fever virus or yellow fever vaccination (only in stage B and C).
- 8. Participation in any other clinical study assessing an investigational medical product in the 30 days prior to the start of the study or during the study period.
- 9. Any condition or situation that could influence the independent consent of participant (e.g. being a direct colleague or family member of study personnel.
- 10. Any other condition or situation that would, in the opinion of the investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol or would compromise the integrity of the data.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, 2333 ZA
M. Roestenberg, MD. PhD.
M. Roestenberg, MD. PhD.
About this study
Official title: Coadministration of Genetically Attenuated Plasmodium Falciparum ∆mei2 (GA2) Sporozoites With Adjuvants - a Proof of Principle Study
This study will assess the coadministration of genetically attenuated Plasmodium falciparum ∆mei2 (GA2) sporozoites with adjuvants (BCG and YF-17D vaccination and imiquimod cream). Primary outcomes will be safety, tolerability and protective efficacy against CHMI.
Read the detailed description
This will be an adaptive design single center, randomized controlled partly blinded, partly open-label clinical proof-of-principle trial of the genetically attenuated parasite GA2 co-administered with adjuvants in healthy, malaria-naïve male and female participants with no prior history of BCG or YF-17D vaccination. A total of 45 participants will be immunized by the bites of 50 GA2 infected mosquitos. Additionally, ten participants will serve as infectivity controls and will be exposed to the bites of 50 uninfected mosquitoes in the immunization phase.
During the 42 days following the immunization, there will be four out-patient visits and one phone call visit to evaluate adverse events and for hematology, biochemistry and immunology laboratory assessment. Six weeks after immunization, all 45 participants will undergo a CHMI through the bites of 5 mosquitos infected with wild-type 3D7 sporozoites. From day 6 to 21 after CHMI, participants will be followed daily on an out-patient basis to determine parasite loads detected by a quantitative polymerase chain reaction (qPCR). As soon as parasitemia is detected (cut-off >100p/mL), or at the latest 28 days after CHMI, participants will be treated with a curative regimen of antimalarials. The trial will be held in two cohorts: the second cohort starting 4 weeks after the first. The first cohort will consist of 10 participants and the second cohort will consist of 15 participants. Both cohorts will be block randomized to the five different study groups.
The study will consist of three stages. In stage A of the study, ten GA2 immunized participants will be compared to five infectivity controls in a blinded design. If the protective efficacy of the GA2 immunized group is ≤7/10 and some efficacy is seen in stage A (either ≥10% protection or significant increase in time to parasitemia) then the study will progress to stage B. In this stage, BCG (n=5), YF-17D (n=5) or imiquimod (n=5) will be applied/administered to the GA2 administration site. Additionally, two infectivity controls will participate in stage B. Stage B will be open label.
Based on the data on safety, tolerability and immunogenicity, the most favorable adjuvant of stage B can be chosen to be further assessed in stage C. In stage C, additional participants will be immunized with 50 GA2 infected mosquitoes in combination with the selected adjuvant. Additionally, a group of five unadjuvanted GA2 immunized participants and three infectivity controls will participate. The adjuvanted group of stage C will be open-label, the unadjuvanted group and the infectivity controls will be blinded.
- Conditions
- Malaria,Falciparum
- Being tested
- GA2, BCG, YF-17D (fractional ID dose), Imiquimod, Mock immunization
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GA2Biological
GA2 sporozoites administered by 50 mosquito bites
BCGBiological
0.1 mL BCG vaccine intradermally
YF-17D (fractional ID dose)Biological
Also called Stamaril
0.1 mL YF17D vaccine intradermally
ImiquimodDrug
Also called Aldara
250mg imiquimod 5% cream topical
Mock immunizationOther
50 bites by uninfected mosquitoes
| Study group | Role | What they receive |
|---|---|---|
| GA2 group (unadjuvanted group) | Experimental | Immunization with 50 GA2-infected mosquito bites Receives: Biological: GA2 |
| Infectivity controls (placebo group) | Placebo comparator | Mock-immunization with 50 uninfected-mosquito bites Receives: Other: Mock immunization |
| BCG group | Experimental | Immunization with 50 GA2-infected mosquito bites and a standard intradermal BCG vaccination (0.1 mL) Receives: Biological: GA2; Biological: BCG |
| YF-17D group | Experimental | Immunization with 50 GA2-infected mosquito bites and a one fifth fractional (0.1 mL) intradermal YF-17D vaccination Receives: Biological: GA2; Biological: YF-17D (fractional ID dose) |
| Imiquimod group | Experimental | Immunization with 50 GA2-infected mosquito bites and 250mg imiquimod cream 5% Receives: Biological: GA2; Drug: Imiquimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to parasitemia
The time to parasitemia (qPCR >100p/mL) (prepatent period) after CHMI in participants immunized with the GA2 parasite co-administered with an adjuvant compared to the unadjuvanted group and the infectivity controls.
Measured: Moment of CHMI to antimalarial treatment (28 days post CHMI)
Safety and tolerability: frequency and magnitude of adverse events in all study groups.
The number of graded adverse events occurring in each group will be calculated as absolute numbers. Frequencies will be calculated by dividing the number of graded adverse events occurring in each group by the total number of volunteers in each group
Measured: Moment of immunization to 35 days post CHMI
Protective efficacy
Proportion of participants immunized with the GA2 parasite co-administered with an adjuvant that do not develop parasitemia (qPCR >100p/mL) (sterile protection) after CHMI comparted the unadjuvanted group and the infectivity controls.
Measured: Moment of CHMI to antimalarial treatment (28 days post CHMI)
Secondary outcomes (1)
Humoral immune responses of volunteers exposed to different intervention arms
Difference in concentration of anti-CSP antibodies between intervention arms as assessed by ELISA.
Measured: Moment of immunization, pre-CHMI and up to 182 days post CHMI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start3 Feb 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
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 Malaria,FalciparumStudies of the same condition, open and under way.
- More trials run by Leiden 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study will consist of three stages (A, B, C). In stage A of the study, ten GA2 immunized participants will be compared to five infectivity controls in a blinded design. If the protective efficacy of the GA2 immunized group is ≤7/10 and some efficacy is seen in stage A (either ≥10% protection or significant increase in time to parasitemia) then the study will progress to stage B. In this stage, BCG (n=5), YF-17D (n=5) or imiquimod (n=5) will be applied/administered to the GA2 administration site. Additionally, two infectivity controls will participate in stage B. Based on the data on safety, tolerability and immunogenicity, the most favorable adjuvant of stage B can be chosen to be further assessed in stage C. In stage C, additional participants will be immunized with 50 GA2 infected mosquitoes in combination with the selected adjuvant. Additionally, a group of five unadjuvanted GA2 immunized participants and three infectivity controls will participate.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meta Roestenberg, Leiden University Medical Center
- Investigators
- Meta Roestenberg, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468606
- Sponsor's protocol ID
- CoGA
- Acronym
- CoGA
- Status last verified
- Feb 2023
- First submitted
- 14 Jul 2022
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roozen GVT, van Schuijlenburg R, Hensen ADO, Koopman JPR, Lamers OAC, Geurten FJA, Sijtsma JC, Baalbergen E, Janse JJ, Chevalley-Maurel S, Naar CM, Bezemer S, Kroeze H, van de Stadt HJF, de Visser B, Meij P, Tihaya MS, Colstrup E, Iliopoulou E, de Bes-Roeleveld HM, Wessels E, van der Stoep MYEC, Janse CJ, Murugan R, Franke-Fayard BMD, Roestenberg M. Single immunization with genetically attenuated Pf∆mei2 (GA2) parasites by mosquito bite in controlled human malaria infection: a placebo-controlled randomized trial. Nat Med. 2025 Jan;31(1):218-222. doi: 10.1038/s41591-024-03347-2. Epub 2025 Jan 3.
PubMed 39753962
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coadministration of Genetically Attenuated Plasmodium Falciparum ∆mei2 (GA2) Sporozoites With Adjuvants - a Proof of Principle Study
- ClinicalTrials.gov ID
- NCT05468606
- Acronym / sponsor ID
- CoGA / CoGA
- Conditions
- Malaria,Falciparum
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Jul 2022 (actual)
- 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.
This study will assess the coadministration of genetically attenuated Plasmodium falciparum ∆mei2 (GA2) sporozoites with adjuvants (BCG and YF-17D vaccination and imiquimod cream). Primary outcomes will be safety, tolerability and protective efficacy against CHMI.
Detailed description
This will be an adaptive design single center, randomized controlled partly blinded, partly open-label clinical proof-of-principle trial of the genetically attenuated parasite GA2 co-administered with adjuvants in healthy, malaria-naïve male and female participants with no prior history of BCG or YF-17D vaccination. A total of 45 participants will be immunized by the bites of 50 GA2 infected mosquitos. Additionally, ten participants will serve as infectivity controls and will be exposed to the bites of 50 uninfected mosquitoes in the immunization phase.
During the 42 days following the immunization, there will be four out-patient visits and one phone call visit to evaluate adverse events and for hematology, biochemistry and immunology laboratory assessment. Six weeks after immunization, all 45 participants will undergo a CHMI through the bites of 5 mosquitos infected with wild-type 3D7 sporozoites. From day 6 to 21 after CHMI, participants will be followed daily on an out-patient basis to determine parasite loads detected by a quantitative polymerase chain reaction (qPCR). As soon as parasitemia is detected (cut-off >100p/mL), or at the latest 28 days after CHMI, participants will be treated with a curative regimen of antimalarials. The trial will be held in two cohorts: the second cohort starting 4 weeks after the first. The first cohort will consist of 10 participants and the second cohort will consist of 15 participants. Both cohorts will be block randomized to the five different study groups.
The study will consist of three stages. In stage A of the study, ten GA2 immunized participants will be compared to five infectivity controls in a blinded design. If the protective efficacy of the GA2 immunized group is ≤7/10 and some efficacy is seen in stage A (either ≥10% protection or significant increase in time to parasitemia) then the study will progress to stage B. In this stage, BCG (n=5), YF-17D (n=5) or imiquimod (n=5) will be applied/administered to the GA2 administration site. Additionally, two infectivity controls will participate in stage B. Stage B will be open label.
Based on the data on safety, tolerability and immunogenicity, the most favorable adjuvant of stage B can be chosen to be further assessed in stage C. In stage C, additional participants will be immunized with 50 GA2 infected mosquitoes in combination with the selected adjuvant. Additionally, a group of five unadjuvanted GA2 immunized participants and three infectivity controls will participate. The adjuvanted group of stage C will be open-label, the unadjuvanted group and the infectivity controls will be blinded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- The study will consist of three stages (A, B, C). In stage A of the study, ten GA2 immunized participants will be compared to five infectivity controls in a blinded design. If the protective efficacy of the GA2 immunized group is ≤7/10 and some efficacy is seen in stage A (either ≥10% protection or significant increase in time to parasitemia) then the study will progress to stage B. In this stage, BCG (n=5), YF-17D (n=5) or imiquimod (n=5) will be applied/administered to the GA2 administration site. Additionally, two infectivity controls will participate in stage B. Based on the data on safety, tolerability and immunogenicity, the most favorable adjuvant of stage B can be chosen to be further assessed in stage C. In stage C, additional participants will be immunized with 50 GA2 infected mosquitoes in combination with the selected adjuvant. Additionally, a group of five unadjuvanted GA2 immunized participants and three infectivity controls will participate.
| Arm | Type | Receives |
|---|---|---|
| GA2 group (unadjuvanted group) | Experimental | Biological: GA2Immunization with 50 GA2-infected mosquito bites |
| Infectivity controls (placebo group) | Placebo comparator | Other: Mock immunizationMock-immunization with 50 uninfected-mosquito bites |
| BCG group | Experimental | Biological: GA2, Biological: BCGImmunization with 50 GA2-infected mosquito bites and a standard intradermal BCG vaccination (0.1 mL) |
| YF-17D group | Experimental | Biological: GA2, Biological: YF-17D (fractional ID dose)Immunization with 50 GA2-infected mosquito bites and a one fifth fractional (0.1 mL) intradermal YF-17D vaccination |
| Imiquimod group | Experimental | Biological: GA2, Drug: ImiquimodImmunization with 50 GA2-infected mosquito bites and 250mg imiquimod cream 5% |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Participant is aged ≥18 and ≤35 years and in good health.
- Participant has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
- Participant is able to communicate well with the investigator
- Participant is available to attend all essential study visits.
- Participant agrees that his/her general practitioner (GP) will be informed about participation in the study.
Key exclusion criteria (17 listed)
- 2. For participants of child bearing potential: breastfeeding, or positive urine pregnancy test prior to immunization or prior to CHMI.
- 3. Any history of malaria or previous participation in any malaria (vaccine) study or CHMI.
- 4. Known hypersensitivity to or contra-indications for both atovaquone/proguanil or artemether/lumefantrine. QT prolonging drugs are only considered an exclusion criterion when QT prolongation is observed at the ECG at screening.
- 5. A history of severe (allergic) reactions to mosquito bites. 6. Any history of infection with mycobacteria or BCG vaccination (only in stage B and C) 7. Any history of infection with yellow fever virus or yellow fever vaccination (only in stage B and C).
- 8. Participation in any other clinical study assessing an investigational medical product in the 30 days prior to the start of the study or 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 |
|---|---|---|
| GA2GA2 sporozoites administered by 50 mosquito bites | Biological | BCG group, GA2 group (unadjuvanted group), Imiquimod group, YF-17D group |
| BCG0.1 mL BCG vaccine intradermally | Biological | BCG group |
| YF-17D (fractional ID dose)Also: Stamaril0.1 mL YF17D vaccine intradermally | Biological | YF-17D group |
| ImiquimodAlso: Aldara250mg imiquimod 5% cream topical | Drug | Imiquimod group |
| Mock immunization50 bites by uninfected mosquitoes | Other | Infectivity controls (placebo group) |
Primary outcome
Time to parasitemia
Time frame: Moment of CHMI to antimalarial treatment (28 days post CHMI)
The time to parasitemia (qPCR >100p/mL) (prepatent period) after CHMI in participants immunized with the GA2 parasite co-administered with an adjuvant compared to the unadjuvanted group and the infectivity controls.
Safety and tolerability: frequency and magnitude of adverse events in all study groups.
Time frame: Moment of immunization to 35 days post CHMI
The number of graded adverse events occurring in each group will be calculated as absolute numbers. Frequencies will be calculated by dividing the number of graded adverse events occurring in each group by the total number of volunteers in each group
Protective efficacy
Time frame: Moment of CHMI to antimalarial treatment (28 days post CHMI)
Proportion of participants immunized with the GA2 parasite co-administered with an adjuvant that do not develop parasitemia (qPCR >100p/mL) (sterile protection) after CHMI comparted the unadjuvanted group and the infectivity controls.
1 secondary outcome
Humoral immune responses of volunteers exposed to different intervention arms
Time frame: Moment of immunization, pre-CHMI and up to 182 days post CHMI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Derived from this study: PubMed 39753962Roozen GVT, van Schuijlenburg R, Hensen ADO, Koopman JPR, Lamers OAC, Geurten FJA, Sijtsma JC, Baalbergen E, Janse JJ, Chevalley-Maurel S, Naar CM, Bezemer S, Kroeze H, van de Stadt HJF, de Visser B, Meij P, Tihaya MS, Colstrup E, Iliopoulou E, de Bes-Roeleveld HM, Wessels E, van der Stoep MYEC, Janse CJ, Murugan R, Franke-Fayard BMD, Roestenberg M. Single immunization with genetically attenuated Pf∆mei2 (GA2) parasites by mosquito bite in controlled human malaria infection: a placebo-controlled randomized trial. Nat Med. 2025 Jan;31(1):218-222. doi: 10.1038/s41591-024-03347-2. Epub 2025 Jan 3.
- Individual participant dataSharing planned: No
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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.
Meta Roestenberg, MD, PhD principal investigator
Leiden 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 Early Phase 1 study testing GA2, BCG and YF-17D (fractional ID dose) in people with Malaria,Falciparum, run by Leiden 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 9 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 10 Feb 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meta Roestenberg, MD, PhD (+31715262102, M.Roestenberg@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to parasitemia (time frame: Moment of CHMI to antimalarial treatment (28 days post CHMI)). The study lists 3 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 NCT05468606, 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 10 Feb 2023.