Plasmodium Falciparum InfectionPhase 1NCT03014258
A Systems Biology Approach to Malaria Immunity
A Phase 1 study testing NF54 P. falciparum malaria challenge in people with Plasmodium Falciparum Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This is a phase I study that will assess the acquisition of immunity to Pf malaria over the course of 5 sequential Controlled Human Malaria Infections (CHMI) over 2-4 years, in 10 healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum Infection
- What is being tested?
- NF54 P. falciparum malaria challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2017to 19 Jul 2019
- Phase
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non-pregnant/non-lactating female between the ages of 18 and 50 years, inclusive.
- Able and willing to participate for the duration of the study.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Able and willing to complete the informed consent process.
- Willing to donate blood for sample storage to be used for future research (Note: refusal to allow future use is exclusionary).
- Willing to refrain from blood donation to blood banks for 3 years following P. falciparum CHMI.
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- Agrees not to travel to a malaria endemic region during the entire course of study participation.
- Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) = / < 35.
- Laboratory Criteria within 56 days prior to enrollment:
- Hemoglobin = / >11.2 g/dL for women; = / > 12.6 g/dL for men.
- Platelet count within institutional normal range.
- Alanine aminotransferase (ALT) = / < upper limit of normal.
- Serum creatinine = / < upper limit of normal.
- Negative for HIV and Hepatitis B/C infection.
- Laboratory Criterion documented any time prior to enrollment:
- Negative sickle cell screening test.
- Female-Specific Criteria:
- Negative beta-HCG pregnancy test (serum) on day of screening or urine pregnancy test at subsequent time points for women of childbearing potential.
- Women of childbearing potential (exclusive of women in a same sex relationship) must agree to use effective means of birth control.* *(e.g. oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner). Women with a history of amenorrhea (> 1 year duration) or surgical or chemical sterilization (e.g. tubal ligation, hysterectomy, other) must provide written documentation of infertility from a health care provider.
Who cannot join
- Women who are breast-feeding or planning to become pregnant during the time interval needed to complete the study.
- Receipt of a malaria vaccine in a prior clinical trial.
- Any history of malaria infection.
- Evidence of increased cardiovascular disease risk; defined as > 10% five year risk by the non-laboratory method.
- Current use of systemic immunosuppressant pharmacotherapy.
- History of a splenectomy, sickle cell disease or sickle cell trait.
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- Known history of anaphylactic response to mosquito-bites; or known allergy to artemether lumefantrine or atovaquone or proguanil or other component of the product.
- Participation in any study involving investigational vaccine or drug within 4 weeks prior to enrollment, or expects to receive vaccine or drug during the 2-month post-challenge period.
- Use or planned use of any drug with anti-malarial activity that would coincide with challenge.
- Anticipated use of medications known to cause drug reactions with atovaquone-proguanil (Malarone(R)) such as cimetidine, metoclopramide, antacids, and kaolin.
- Plans to undergo surgery (elective or otherwise) between enrollment and 4 weeks (28 days) after any of the challenges.
- Received a licensed vaccine within 1 month prior to enrollment in this study or expects to receive one during the 28 day post challenge period.
- History of psychiatric disorders or behavioral tendencies (including active alcohol or drug abuse) that in the opinion of the investigator would make compliance with the protocol difficult.* *Medical and psychiatric illness defined as personality disorders, anxiety disorders, or schizophrenia or social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent or to comply with the protocol schedule.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, 21201-1509
About this study
Official title: A Systems Biology Approach to Malaria Immunity: Repetitive Controlled Human Malaria Infection (CHMI) Study in Malaria-Naïve Adults Using NF54 Strain Plasmodium Falciparum (Pf)
This is a phase I study that will assess the acquisition of immunity to Pf malaria over the course of 5 sequential Controlled Human Malaria Infections (CHMI) over 2-4 years, in 10 healthy adult participants. 10 subjects will initially be challenged with 5 uninfected mosquitoes (mock), followed by 5 challenges with 5 mosquitoes infected with drug sensitive, P. falciparum parasites (strain NF54) 2, 8, 14-20, 20-32, and 32-36 months later. For the final four infective CMHIs six additional immunologic malaria-naïve subjects will be enrolled and challenged as infectivity controls. If dropouts occur within the original 10 person cohort, and two or more CHMI remain, back-up replacement volunteers will be recruited to undergo successive CHMI with the core group. All volunteers (repeat CHMI subjects and infectivity controls) will be evaluated as part of an inpatient stay (or outpatient daily follow-up) to diagnose Pf malaria infection and treat with Coartem(R) (artemether/lumefantrine) or Malarone(R) (Atovaquone/proguanil). Daily observation will occur from Study Days 9-19 or until three-day directly observed therapy for P. falciparum infection is complete and two negative smears separated by a time interval >12 hours have been documented. A third negative smear >12 hours after the previous two daily smears will be documented to affirm malaria cure. Infectivity Controls enrolled as part of CHMI #5 will be treated based on concomitant us qPCR results. The repeat CHMI subjects will have additional outpatient visits days 1, 3, 5, and 7 after the challenge to obtain blood samples to monitor the development of immunity. The study is expected to last for 48 months and will include approximately 34 healthy male and female volunteers (10 active study volunteers and 18 naïve controls to confirm Pf infectivity during the 2nd -5th CHMI challenges) ages 18 to 50 years, inclusive, from the greater Baltimore community. The primary objective of this study is to determine whether protective immunity against parasite infection develops following repeat CHMI.
Read the detailed description
This is a phase I study that will assess the acquisition of immunity to Pf malaria over the course of 5 sequential Controlled Human Malaria Infections (CHMI) over 2-4 years, in 10 healthy adult participants. 10 subjects will initially be challenged with 5 uninfected mosquitoes (mock), followed by 5 challenges with 5 mosquitoes infected with drug sensitive, P. falciparum parasites (strain NF54) 2, 8, 14-20, 20-32, and 32-36 months later. For the final four infective CMHIs six additional immunologic malaria-naïve subjects will be enrolled and challenged as infectivity controls. If dropouts occur within the original 10 person cohort, and two or more CHMI remain, back-up replacement volunteers will be recruited to undergo successive CHMI with the core group. All volunteers (repeat CHMI subjects and infectivity controls) will be evaluated as part of an inpatient stay (or outpatient daily follow-up) to diagnose Pf malaria infection and treat with Coartem(R) (artemether/lumefantrine) or Malarone(R) (Atovaquone/proguanil). Daily observation will occur from Study Days 9-19 or until three-day directly observed therapy for P. falciparum infection is complete and two negative smears separated by a time interval >12 hours have been documented. A third negative smear >12 hours after the previous two daily smears will be documented to affirm malaria cure. Infectivity Controls enrolled as part of CHMI #5 will be treated based on concomitant us qPCR results. The repeat CHMI subjects will have additional outpatient visits days 1, 3, 5, and 7 after the challenge to obtain blood samples to monitor the development of immunity. The study is expected to last for 48 months and will include approximately 34 healthy male and female volunteers (10 active study volunteers and 18 naïve controls to confirm Pf infectivity during the 2nd -5th CHMI challenges) ages 18 to 50 years, inclusive, from the greater Baltimore community. The primary objective of this study is to determine whether protective immunity against parasite infection develops following repeat CHMI. The secondary objectives are to: 1) determine whether clinical signs and symptoms of malaria decrease in intensity and duration following repeat CHMI, 2) track the production of antibodies that react with P. falciparum sporozoites and blood stage parasites.
- Conditions
- Plasmodium Falciparum Infection
- Being tested
- NF54 P. falciparum malaria challenge
- Keywords
- Biology, falciparum, Immunity, Infections, Malaria, Pf, Plasmodium, Systems
- Medical subject headings
- Infections, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NF54 P. falciparum malaria challengeBiological
Aseptically-raised A. stephensi female mosquitoes infected with aseptically-raised P. falciparum parasites of the NF54 strain.
| Study group | Role | What they receive |
|---|---|---|
| Control Cohort 1 | Active comparator | Immunologic malaria-naïve subjects will undergo CHMI #2 with 5 NF54 P. falciparum-infected mosquitoes at months 8-9. n=6. Receives: Biological: NF54 P. falciparum malaria challenge |
| Control Cohort 2 | Active comparator | Immunologic malaria-naïve subjects will undergo a CHMI #3 with 5 NF54 P. falciparum-infected mosquitoes at 6-12 months post CHMI #2. n=6. Receives: Biological: NF54 P. falciparum malaria challenge |
| Control Cohort 3 | Active comparator | Immunologic malaria-naïve subjects will undergo a CHMI #4 with 5 NF54 P. falciparum-infected mosquitoes at 6-12 months post CHMI #3. n=6. Receives: Biological: NF54 P. falciparum malaria challenge |
| Control Cohort 4 | Active comparator | Immunologic malaria-naïve subjects will undergo a CHMI #5 with 5 NF54 P. falciparum-infected mosquitoes at 6-12 months post CHMI #4. n=6. Receives: Biological: NF54 P. falciparum malaria challenge |
| Repeat CHMI | Experimental | Subjects will initially be challenged with 5 uninfected mosquitoes (mock), followed by 5 challenges (CHMI # 1-5) with 5 NF54 P. falciparum-infected mosquitoes 2, 8, 14-20, and 20-32, and 32-36 months later. n=10. Receives: Biological: NF54 P. falciparum malaria challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects testing positive for parasites
As measured using real-time quantitative polymerase chain reaction (PCR)
Measured: Study Day 6 through Study Day 29
Percentage of subjects with positive malaria smear
For infectivity controls enrolled into infective CHMI #5, malaria detection will rely upon ultra-sensitive quantitative polymerase chain reaction (us-qPCR) to ensure safety while conducting this portion of the study as an outpatient
Measured: Study Day 9 through Study Day 29
Quantification of parasite infection
As measured using real-time quantitative polymerase chain reaction (PCR) during the surveillance period after infected CHMI.
Measured: Study Day 6 through Study Day 29
Secondary outcomes (6)
Antibody reactivity against Circumsporozoite protein (CSP)
Measured using plasma obtained during the surveillance period. Antibody reactivity is defined as the optical density at 410 nM of a 1/300 dilution of the volunteers plasma sample minus the optical density at 410 nM of a 1/300 dilution of the volunteer's baseline sample.
Measured: Up to Study Day 21
Antibody reactivity against Glutamate-rich protein (GLURP)
Measured using plasma obtained during the surveillance period. Antibody reactivity is defined as the optical density at 410 nM of a 1/300 dilution of the volunteers plasma sample minus the optical density at 410 nM of a 1/300 dilution of the volunteer's baseline sample.
Measured: Up to Study Day 21
Antibody reactivity against Plasmodium Falciparum liver- and erythrocytic-stage antigen
Measured using plasma obtained during the surveillance period. Antibody reactivity is defined as the optical density at 410 nM of a 1/300 dilution of the volunteers plasma sample minus the optical density at 410 nM of a 1/300 dilution of the volunteer's baseline sample.
Measured: Up to Study Day 21
Antibody reactivity against Plasmodium Falciparum pre-erythrocytic antigen
Measured using plasma obtained during the surveillance period. Antibody reactivity is defined as the optical density at 410 nM of a 1/300 dilution of the volunteers plasma sample minus the optical density at 410 nM of a 1/300 dilution of the volunteer's baseline sample.
Measured: Up to Study Day 21
Percentage of subjects displaying signs and symptoms attributable to malaria
Such as malaise, chills/rigors, nausea, vomiting, dizziness, arthralgia, abdominal pain, myalgia, and headache
Measured: Study Day 6 through Study Day 29
Percentage of subjects with fever attributable to malaria
Fever as defined as >38 degrees Celsius
Measured: Study Day 6 through Study Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start7 Jun 2017
- Primary completion19 Jul 2019
- Study completion19 Jul 2019
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 Plasmodium Falciparum InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014258
- Sponsor's protocol ID
- 15-0058
- Status last verified
- 27 May 2021
- First submitted
- 15 Dec 2016
- Last updated
- 8 Jun 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ferrer P, Berry AA, Bucsan AN, Prajapati SK, Krishnan K, Barbeau MC, Rickert DM, Guerrero SM, Usui M, Abebe Y, Patil A, Chakravarty S, Billingsley PF, Pa'ahana-Brown F, Strauss K, Shrestha B, Nomicos E, Deye GA, Sim BKL, Hoffman SL, Williamson KC, Lyke KE. Repeat controlled human Plasmodium falciparum infections delay bloodstream patency and reduce symptoms. Nat Commun. 2024 Jun 18;15(1):5194. doi: 10.1038/s41467-024-49041-2.
PubMed 38890271
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systems Biology Approach to Malaria Immunity: Repetitive Controlled Human Malaria Infection (CHMI) Study in Malaria-Naïve Adults Using NF54 Strain Plasmodium Falciparum (Pf)
- ClinicalTrials.gov ID
- NCT03014258
- Acronym / sponsor ID
- 15-0058
- Conditions
- Plasmodium Falciparum Infection
- Keywords
- Biology, falciparum, Immunity, Infections, Malaria, Pf, Plasmodium, Systems
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 9 Jan 2017 (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.
This is a phase I study that will assess the acquisition of immunity to Pf malaria over the course of 5 sequential Controlled Human Malaria Infections (CHMI) over 2-4 years, in 10 healthy adult participants. 10 subjects will initially be challenged with 5 uninfected mosquitoes (mock), followed by 5 challenges with 5 mosquitoes infected with drug sensitive, P. falciparum parasites (strain NF54) 2, 8, 14-20, 20-32, and 32-36 months later. For the final four infective CMHIs six additional immunologic malaria-naïve subjects will be enrolled and challenged as infectivity controls. If dropouts occur within the original 10 person cohort, and two or more CHMI remain, back-up replacement volunteers will be recruited to undergo successive CHMI with the core group. All volunteers (repeat CHMI subjects and infectivity controls) will be evaluated as part of an inpatient stay (or outpatient daily follow-up) to diagnose Pf malaria infection and treat with Coartem(R) (artemether/lumefantrine) or Malarone(R) (Atovaquone/proguanil). Daily observation will occur from Study Days 9-19 or until three-day directly observed therapy for P. falciparum infection is complete and two negative smears separated by a time interval >12 hours have been documented. A third negative smear >12 hours after the previous two daily smears will be documented to affirm malaria cure. Infectivity Controls enrolled as part of CHMI #5 will be treated based on concomitant us qPCR results. The repeat CHMI subjects will have additional outpatient visits days 1, 3, 5, and 7 after the challenge to obtain blood samples to monitor the development of immunity. The study is expected to last for 48 months and will include approximately 34 healthy male and female volunteers (10 active study volunteers and 18 naïve controls to confirm Pf infectivity during the 2nd -5th CHMI challenges) ages 18 to 50 years, inclusive, from the greater Baltimore community. The primary objective of this study is to determine whether protective immunity against parasite infection develops following repeat CHMI.
Detailed description
This is a phase I study that will assess the acquisition of immunity to Pf malaria over the course of 5 sequential Controlled Human Malaria Infections (CHMI) over 2-4 years, in 10 healthy adult participants. 10 subjects will initially be challenged with 5 uninfected mosquitoes (mock), followed by 5 challenges with 5 mosquitoes infected with drug sensitive, P. falciparum parasites (strain NF54) 2, 8, 14-20, 20-32, and 32-36 months later. For the final four infective CMHIs six additional immunologic malaria-naïve subjects will be enrolled and challenged as infectivity controls. If dropouts occur within the original 10 person cohort, and two or more CHMI remain, back-up replacement volunteers will be recruited to undergo successive CHMI with the core group. All volunteers (repeat CHMI subjects and infectivity controls) will be evaluated as part of an inpatient stay (or outpatient daily follow-up) to diagnose Pf malaria infection and treat with Coartem(R) (artemether/lumefantrine) or Malarone(R) (Atovaquone/proguanil). Daily observation will occur from Study Days 9-19 or until three-day directly observed therapy for P. falciparum infection is complete and two negative smears separated by a time interval >12 hours have been documented. A third negative smear >12 hours after the previous two daily smears will be documented to affirm malaria cure. Infectivity Controls enrolled as part of CHMI #5 will be treated based on concomitant us qPCR results. The repeat CHMI subjects will have additional outpatient visits days 1, 3, 5, and 7 after the challenge to obtain blood samples to monitor the development of immunity. The study is expected to last for 48 months and will include approximately 34 healthy male and female volunteers (10 active study volunteers and 18 naïve controls to confirm Pf infectivity during the 2nd -5th CHMI challenges) ages 18 to 50 years, inclusive, from the greater Baltimore community. The primary objective of this study is to determine whether protective immunity against parasite infection develops following repeat CHMI. The secondary objectives are to: 1) determine whether clinical signs and symptoms of malaria decrease in intensity and duration following repeat CHMI, 2) track the production of antibodies that react with P. falciparum sporozoites and blood stage parasites.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control Cohort 1 | Active comparator | Biological: NF54 P. falciparum malaria challengeImmunologic malaria-naïve subjects will undergo CHMI #2 with 5 NF54 P. falciparum-infected mosquitoes at months 8-9. n=6. |
| Control Cohort 2 | Active comparator | Biological: NF54 P. falciparum malaria challengeImmunologic malaria-naïve subjects will undergo a CHMI #3 with 5 NF54 P. falciparum-infected mosquitoes at 6-12 months post CHMI #2. n=6. |
| Control Cohort 3 | Active comparator | Biological: NF54 P. falciparum malaria challengeImmunologic malaria-naïve subjects will undergo a CHMI #4 with 5 NF54 P. falciparum-infected mosquitoes at 6-12 months post CHMI #3. n=6. |
| Control Cohort 4 | Active comparator | Biological: NF54 P. falciparum malaria challengeImmunologic malaria-naïve subjects will undergo a CHMI #5 with 5 NF54 P. falciparum-infected mosquitoes at 6-12 months post CHMI #4. n=6. |
| Repeat CHMI | Experimental | Biological: NF54 P. falciparum malaria challengeSubjects will initially be challenged with 5 uninfected mosquitoes (mock), followed by 5 challenges (CHMI # 1-5) with 5 NF54 P. falciparum-infected mosquitoes 2, 8, 14-20, and 20-32, and 32-36 months later. n=10. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Male or non-pregnant/non-lactating female between the ages of 18 and 50 years, inclusive.
- Able and willing to participate for the duration of the study.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Able and willing to complete the informed consent process.
- Willing to donate blood for sample storage to be used for future research (Note: refusal to allow future use is exclusionary).
Key exclusion criteria (13 listed)
- Women who are breast-feeding or planning to become pregnant during the time interval needed to complete the study.
- Receipt of a malaria vaccine in a prior clinical trial.
- Any history of malaria infection.
- Evidence of increased cardiovascular disease risk; defined as > 10% five year risk by the non-laboratory method.
- Current use of systemic immunosuppressant pharmacotherapy.
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 |
|---|---|---|
| NF54 P. falciparum malaria challengeAseptically-raised A. stephensi female mosquitoes infected with aseptically-raised P. falciparum parasites of the NF54 strain. | Biological | Control Cohort 1, Control Cohort 2, Control Cohort 3, Control Cohort 4, Repeat CHMI |
Primary outcome
Percentage of subjects testing positive for parasites
Time frame: Study Day 6 through Study Day 29
As measured using real-time quantitative polymerase chain reaction (PCR)
Percentage of subjects with positive malaria smear
Time frame: Study Day 9 through Study Day 29
For infectivity controls enrolled into infective CHMI #5, malaria detection will rely upon ultra-sensitive quantitative polymerase chain reaction (us-qPCR) to ensure safety while conducting this portion of the study as an outpatient
Quantification of parasite infection
Time frame: Study Day 6 through Study Day 29
As measured using real-time quantitative polymerase chain reaction (PCR) during the surveillance period after infected CHMI.
6 secondary outcomes
Antibody reactivity against Circumsporozoite protein (CSP)
Time frame: Up to Study Day 21
Antibody reactivity against Glutamate-rich protein (GLURP)
Time frame: Up to Study Day 21
Antibody reactivity against Plasmodium Falciparum liver- and erythrocytic-stage antigen
Time frame: Up to Study Day 21
Antibody reactivity against Plasmodium Falciparum pre-erythrocytic antigen
Time frame: Up to Study Day 21
Percentage of subjects displaying signs and symptoms attributable to malaria
Time frame: Study Day 6 through Study Day 29
Percentage of subjects with fever attributable to malaria
Time frame: Study Day 6 through Study Day 29
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 8 Jun 2021.
- Derived from this study: PubMed 38890271Ferrer P, Berry AA, Bucsan AN, Prajapati SK, Krishnan K, Barbeau MC, Rickert DM, Guerrero SM, Usui M, Abebe Y, Patil A, Chakravarty S, Billingsley PF, Pa'ahana-Brown F, Strauss K, Shrestha B, Nomicos E, Deye GA, Sim BKL, Hoffman SL, Williamson KC, Lyke KE. Repeat controlled human Plasmodium falciparum infections delay bloodstream patency and reduce symptoms. Nat Commun. 2024 Jun 18;15(1):5194. doi: 10.1038/s41467-024-49041-2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NF54 P. falciparum malaria challenge in people with Plasmodium Falciparum Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 19 inclusion and 13 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 8 Jun 2021. 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 United States. 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.
What does this 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.
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?
Percentage of subjects testing positive for parasites (time frame: Study Day 6 through Study Day 29). 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 NCT03014258, 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 8 Jun 2021.