Plasmodium Falciparum MalariaPhase 1/2NCT04577066
Safety and Preliminary Protective Efficacy of Genetically Attenuated GA2 Parasites.
A Phase 1/2 study testing GA2 and GA1 in people with Plasmodium Falciparum Malaria, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
This study will consist of two phases and be aimed at assessing the safety and tolerability of the new genetically attenuated GA2 malaria parasite (Phase 1) and its preliminary protective efficacy against controlled human malaria infection (Phase 2) in healthy Dutch volunteers. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum Malaria
- What is being tested?
- GA2 and GA1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Sep 2021to 22 Dec 2022
- Phase
- Phase 1/2
- 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.
- Furthermore, the subject will remain within the Netherlands from day -1 till day +28 after each parasite exposure. After CHMI, subjects have to be reachable by phone (24/7) from day -1 until day 35.
- Subject agrees to inform his/her general practitioner (GP) about 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 Sanquin guidelines.
- Non-pregnant, non-lactating females of reproductive potential (i.e., have a uterus and are neither surgically sterilized nor post-menopausal) agree to use adequate contraception and to not breastfeed for the duration of study.
- Subject agrees to refrain from intensive physical exercise (disproportionate to the subjects' usual daily activity or exercise routine) for twenty-one days following each immunization and during the malaria challenge period.
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, hematological, infectious, immune-deficient, psychiatric or 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:
- Body weight <50 kg or Body Mass Index (BMI) <18.0 or >30.0 kg/m2 at screening.
- 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); i. An estimated ten-year risk of fatal cardiovascular disease of ≥5% at screening, as determined by the Systematic Coronary Risk Evaluation (SCORE); ii. 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.
- 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.
Show all 16Show fewer
- 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 function in the period of one year prior to study onset, positive urine toxicology test for cocaine, amphetamines or cannabis at screening.
- For female subjects: breastfeeding, or positive urine pregnancy test at screening or prior to immunization or prior to CHMI.
- Any history of malaria, positive serology for Pf, or previous participation in any malaria (vaccine) study or CHMI.
- Known hypersensitivity to or contra-indications (including co-medication) for use of atovaquone/proguanil or artemether/lumefantrine, or history of severe (allergic) reactions to MB.
- Receipt of any vaccinations in the three months prior to the start of the study or plans to receive any other vaccinations during the study period or up to eight weeks thereafter. Exceptions are made for influenza vaccination and for vaccination against the coronavirus SARS-COV2 or any other vaccination which cannot be reasonably withheld or postponed.
- 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 Parasitology, Medical Microbiology or Infectious Diseases of the RadboudUMC or the LUMC.
- 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 or would compromise the integrity of the data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Protective Efficacy of Genetically Attenuated Pf∆mei2 (Also Referred to as GA2) Malaria Parasites in Healthy Dutch Volunteers.
This study will consist of two phases and be aimed at assessing the safety and tolerability of the new genetically attenuated GA2 malaria parasite (Phase 1) and its preliminary protective efficacy against controlled human malaria infection (Phase 2) in healthy Dutch volunteers.
Read the detailed description
Malaria is one of the most common tropical diseases, accounting for 228 million infections and 450.000 deaths each year. It is caused by five species of protozoan parasites belonging to the genus of the Plasmodia. Plasmodia have a complex life cycle: they are injected into the human host by female Anopheles mosquitos, migrate to the liver to replicate and then enter red blood cells. The typical symptoms of malaria with fever episodes are caused by the bursting of red blood cells, as the parasites leave to infect new cells.
The rising resistance of both parasites against anti-malarial drugs and mosquitoes against insecticides, make the need to eradicate malaria even more impellent. A promising approach to disease control is the development of an effective vaccine. Among the different approaches to vaccine development, live attenuated parasites stand out for their high protective efficacy (>90%).
The GA2 parasite, a new genetically attenuated malaria parasite, which is derived from the NF45 Plasmodium falciparum strain and has been engineered to arrest development in the liver before entering the bloodstream, was recently created. It should therefore not be able to cause malaria in humans. The idea is that the GA2 parasite will prime the immune system for recognition of non attenuated parasites in the future without causing disease itself. In other words, exposure to the innocuous GA2 parasite could confer protection against pathogenic malaria parasites.
Hence, this study is aimed at investigating the safety and tolerability of the GA2 parasite and at determining its potential protective efficacy against controlled human malaria infection. The former question will be investigated by exposing volunteers to sequentially increasing numbers of GA2-infected mosquito bites. The latter question will be investigated by repeatedly (3 times) exposing volunteers to the GA2 parasite and once to unattenuated parasites. The efficacy of the GA2 parasite will be compared to another genetically attenuated parasite, the GA1, which in previous studies has been shown to be safe and well-tolerated but only have limited protective efficacy. There will also be a placebo group.
- Conditions
- Plasmodium Falciparum Malaria
- Being tested
- GA2, GA1, Placebo
- Keywords
- Malaria, Plasmodium falciparum, Genetically attenuated parasites
- 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.
GA2Other
15 volunteers will receive 50 GA2-infected mosquito bites. The GA2 parasite is a new genetically attenuated Plasmodium falciparum parasite, which arrests development in the liver and should not be able to cause malaria in humans.
GA1Other
10 volunteers will receive 50 GA1-infected mosquito bites. The GA1 parasite is a genetically attenuated Plasmodium falciparum parasite, which arrests development in the liver and is not able to cause malaria in humans.
PlaceboOther
5 volunteers will receive 50 uninfected mosquito bites.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (GA2) | Experimental | Volunteers will be exposed to GA2-infected mosquito bites. Receives: Other: GA2 |
| Group 2 (GA1) | Active comparator | Volunteers will be exposed to the GA1-infected mosquito bites. Receives: Other: GA1 |
| Group 3 (Placebo) | Placebo comparator | Volunteers will be exposed to uninfected mosquito bites. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of volunteers with blood-stage parasitemia.
The number of volunteers developing a breakthrough blood-stage infection after exposure to the GA2 parasite will be calculated as absolute numbers. Frequencies will be calculated by dividing the number of qPCR positive volunteers by the total number of volunteers in each group and multiplying the result by 100.
Measured: From time of exposure to 28 days later.
Number of volunteers protected against controlled human malaria infection immunisation with the GA2 parasite.
The number of volunteers protected against CHMI in each group will be calculated as absolute numbers. Frequencies will be calculated by dividing the number of qPCR positive volunteers by the total number of volunteers in each group and multiplying the result by 100. The difference between the intervention group (receiving bites of GA2-infected mosquitoes) and control group (receiving bites of uninfected mosquitoes) will be calculated by means of the Chi square test.
Measured: From first immunisation to 104 days later.
Number and magnitude of adverse events in Phase 1 and Phase 2.
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: From exposure to maximum 264 days later.
Secondary outcomes (2)
Humoral immune responses of volunteers exposed to the GA2 and GA1 parasite.
Difference in concentration of anti-CSP antibodies between GA2 and GA1 immunised volunteers as assessed by ELISA prior to controlled human infection (study day 75).
Measured: From time of exposure to maximum 264 days later.
Cellular immune response of volunteers exposed to the GA2 and GA1 parasite.
Difference in percentage of CD4+ and CD8+ T-cells producing IFN-γ between GA2 and GA1 immunised volunteers as assessed by flow cytometry prior tot controlled human infection (study day 75).
Measured: From time of exposure to maximum 264 days later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start27 Sep 2021
- Primary completion30 May 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Plasmodium Falciparum MalariaStudies 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
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial has both a sequential as well as a parallel interventional study model. The safety and tolerability of the GA2 parasite will be assessed in phase 1 by means of a sequential study model. There will be 2 cohorts, which will be recruited sequentially and exposed to increasing numbers of infected mosquito bites. The preliminary protective efficacy of the GA2 parasite will be assessed in phase 2 by means of a parallel study model. There will be 3 groups of volunteers, who will be exposed to either GA2-infected, GA1-infected or uninfected mosquito bites.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
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, Prof., Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577066
- Sponsor's protocol ID
- GA2
- Status last verified
- Jan 2023
- First submitted
- 22 Sep 2020
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ashley EA, Pyae Phyo A, Woodrow CJ. Malaria. Lancet. 2018 Apr 21;391(10130):1608-1621. doi: 10.1016/S0140-6736(18)30324-6. Epub 2018 Apr 6.
PubMed 29631781Hoffman SL, Goh LM, Luke TC, Schneider I, Le TP, Doolan DL, Sacci J, de la Vega P, Dowler M, Paul C, Gordon DM, Stoute JA, Church LW, Sedegah M, Heppner DG, Ballou WR, Richie TL. Protection of humans against malaria by immunization with radiation-attenuated Plasmodium falciparum sporozoites. J Infect Dis. 2002 Apr 15;185(8):1155-64. doi: 10.1086/339409. Epub 2002 Apr 1.
PubMed 11930326Roestenberg 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 19641203Lamers OAC, Franke-Fayard BMD, Koopman JPR, Roozen GVT, Janse JJ, Chevalley-Maurel SC, Geurten FJA, de Bes-Roeleveld HM, Iliopoulou E, Colstrup E, Wessels E, van Gemert GJ, van de Vegte-Bolmer M, Graumans W, Stoter TR, Mordmuller BG, Houlder EL, Bousema T, Murugan R, McCall MBB, Janse CJ, Roestenberg M. Safety and Efficacy of Immunization with a Late-Liver-Stage Attenuated Malaria Parasite. N Engl J Med. 2024 Nov 21;391(20):1913-1923. doi: 10.1056/NEJMoa2313892.
PubMed 39565990
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Protective Efficacy of Genetically Attenuated Pf∆mei2 (Also Referred to as GA2) Malaria Parasites in Healthy Dutch Volunteers.
- ClinicalTrials.gov ID
- NCT04577066
- Acronym / sponsor ID
- GA2
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- Malaria, Plasmodium falciparum, Genetically attenuated parasites
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 6 Oct 2020 (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 consist of two phases and be aimed at assessing the safety and tolerability of the new genetically attenuated GA2 malaria parasite (Phase 1) and its preliminary protective efficacy against controlled human malaria infection (Phase 2) in healthy Dutch volunteers.
Detailed description
Malaria is one of the most common tropical diseases, accounting for 228 million infections and 450.000 deaths each year. It is caused by five species of protozoan parasites belonging to the genus of the Plasmodia. Plasmodia have a complex life cycle: they are injected into the human host by female Anopheles mosquitos, migrate to the liver to replicate and then enter red blood cells. The typical symptoms of malaria with fever episodes are caused by the bursting of red blood cells, as the parasites leave to infect new cells.
The rising resistance of both parasites against anti-malarial drugs and mosquitoes against insecticides, make the need to eradicate malaria even more impellent. A promising approach to disease control is the development of an effective vaccine. Among the different approaches to vaccine development, live attenuated parasites stand out for their high protective efficacy (>90%).
The GA2 parasite, a new genetically attenuated malaria parasite, which is derived from the NF45 Plasmodium falciparum strain and has been engineered to arrest development in the liver before entering the bloodstream, was recently created. It should therefore not be able to cause malaria in humans. The idea is that the GA2 parasite will prime the immune system for recognition of non attenuated parasites in the future without causing disease itself. In other words, exposure to the innocuous GA2 parasite could confer protection against pathogenic malaria parasites.
Hence, this study is aimed at investigating the safety and tolerability of the GA2 parasite and at determining its potential protective efficacy against controlled human malaria infection. The former question will be investigated by exposing volunteers to sequentially increasing numbers of GA2-infected mosquito bites. The latter question will be investigated by repeatedly (3 times) exposing volunteers to the GA2 parasite and once to unattenuated parasites. The efficacy of the GA2 parasite will be compared to another genetically attenuated parasite, the GA1, which in previous studies has been shown to be safe and well-tolerated but only have limited protective efficacy. There will also be a placebo group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This trial has both a sequential as well as a parallel interventional study model. The safety and tolerability of the GA2 parasite will be assessed in phase 1 by means of a sequential study model. There will be 2 cohorts, which will be recruited sequentially and exposed to increasing numbers of infected mosquito bites. The preliminary protective efficacy of the GA2 parasite will be assessed in phase 2 by means of a parallel study model. There will be 3 groups of volunteers, who will be exposed to either GA2-infected, GA1-infected or uninfected mosquito bites.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (GA2) | Experimental | Other: GA2Volunteers will be exposed to GA2-infected mosquito bites. |
| Group 2 (GA1) | Active comparator | Other: GA1Volunteers will be exposed to the GA1-infected mosquito bites. |
| Group 3 (Placebo) | Placebo comparator | Other: PlaceboVolunteers will be exposed to uninfected mosquito bites. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 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.
- Furthermore, the subject will remain within the Netherlands from day -1 till day +28 after each parasite exposure. After CHMI, subjects have to be reachable by phone (24/7) from day -1 until day 35.
- Subject agrees to inform his/her general practitioner (GP) about participation in the study.
Key exclusion criteria (16 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, hematological, infectious, immune-deficient, psychiatric or 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:
- For female subjects: breastfeeding, or positive urine pregnancy test at screening or prior to immunization or prior to CHMI.
- Any history of malaria, positive serology for Pf, or previous participation in any malaria (vaccine) study or CHMI.
- Known hypersensitivity to or contra-indications (including co-medication) for use of atovaquone/proguanil or artemether/lumefantrine, or history of severe (allergic) reactions to MB.
- Receipt of any vaccinations in the three months prior to the start of the study or plans to receive any other vaccinations during the study period or up to eight weeks thereafter. Exceptions are made for influenza vaccination and for vaccination against the coronavirus SARS-COV2 or any other vaccination which cannot be reasonably withheld or postponed.
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 |
|---|---|---|
| GA215 volunteers will receive 50 GA2-infected mosquito bites. The GA2 parasite is a new genetically attenuated Plasmodium falciparum parasite, which arrests development in the liver and should not be able to cause malaria in humans. | Other | Group 1 (GA2) |
| GA110 volunteers will receive 50 GA1-infected mosquito bites. The GA1 parasite is a genetically attenuated Plasmodium falciparum parasite, which arrests development in the liver and is not able to cause malaria in humans. | Other | Group 2 (GA1) |
| Placebo5 volunteers will receive 50 uninfected mosquito bites. | Other | Group 3 (Placebo) |
Primary outcome
Number of volunteers with blood-stage parasitemia.
Time frame: From time of exposure to 28 days later.
The number of volunteers developing a breakthrough blood-stage infection after exposure to the GA2 parasite will be calculated as absolute numbers. Frequencies will be calculated by dividing the number of qPCR positive volunteers by the total number of volunteers in each group and multiplying the result by 100.
Number of volunteers protected against controlled human malaria infection immunisation with the GA2 parasite.
Time frame: From first immunisation to 104 days later.
The number of volunteers protected against CHMI in each group will be calculated as absolute numbers. Frequencies will be calculated by dividing the number of qPCR positive volunteers by the total number of volunteers in each group and multiplying the result by 100. The difference between the intervention group (receiving bites of GA2-infected mosquitoes) and control group (receiving bites of uninfected mosquitoes) will be calculated by means of the Chi square test.
Number and magnitude of adverse events in Phase 1 and Phase 2.
Time frame: From exposure to maximum 264 days later.
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.
2 secondary outcomes
Humoral immune responses of volunteers exposed to the GA2 and GA1 parasite.
Time frame: From time of exposure to maximum 264 days later.
Cellular immune response of volunteers exposed to the GA2 and GA1 parasite.
Time frame: From time of exposure to maximum 264 days later.
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 13 Jan 2023.
- Background: PubMed 29631781Ashley EA, Pyae Phyo A, Woodrow CJ. Malaria. Lancet. 2018 Apr 21;391(10130):1608-1621. doi: 10.1016/S0140-6736(18)30324-6. Epub 2018 Apr 6.
- Background: PubMed 11930326Hoffman SL, Goh LM, Luke TC, Schneider I, Le TP, Doolan DL, Sacci J, de la Vega P, Dowler M, Paul C, Gordon DM, Stoute JA, Church LW, Sedegah M, Heppner DG, Ballou WR, Richie TL. Protection of humans against malaria by immunization with radiation-attenuated Plasmodium falciparum sporozoites. J Infect Dis. 2002 Apr 15;185(8):1155-64. doi: 10.1086/339409. Epub 2002 Apr 1.
- 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.
- Derived from this study: PubMed 39565990Lamers OAC, Franke-Fayard BMD, Koopman JPR, Roozen GVT, Janse JJ, Chevalley-Maurel SC, Geurten FJA, de Bes-Roeleveld HM, Iliopoulou E, Colstrup E, Wessels E, van Gemert GJ, van de Vegte-Bolmer M, Graumans W, Stoter TR, Mordmuller BG, Houlder EL, Bousema T, Murugan R, McCall MBB, Janse CJ, Roestenberg M. Safety and Efficacy of Immunization with a Late-Liver-Stage Attenuated Malaria Parasite. N Engl J Med. 2024 Nov 21;391(20):1913-1923. doi: 10.1056/NEJMoa2313892.
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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, Prof. 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 Phase 1/2 study testing GA2 and GA1 in people with Plasmodium Falciparum Malaria, 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 8 inclusion and 16 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 13 Jan 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of volunteers with blood-stage parasitemia. (time frame: From time of exposure to 28 days later.). 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 NCT04577066, which also lists 4 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 13 Jan 2023.