Malaria,FalciparumPhase 1NCT03882528

Evaluate the Infectivity Equivalence of Current and New Lots of Plasmodium Falciparum Strain NF54

A Phase 1 study testing Plasmodium falciparum malaria parasite in people with Malaria,Falciparum, run by U.S. Army Medical Research and Development Command at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Objectives: Primary: To characterize the infectivity of the new lot of Plasmodium falciparum strain 3D7 within the standard WRAIR CHMI model as compared to the current lot (historical data) Secondary: To assess safety of the new lot of P falciparum parasites To assess the kinetics of detecting parasitemia and parasite… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Malaria,Falciparum
What is being tested?: Plasmodium falciparum malaria parasite
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 4 Mar 2019to 16 May 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

To be eligible for this study, you must meet ALL of the following conditions:
You are between the ages of 18 and 50 years old.
You are willing and able to participate in all planned study visits for the duration of the study.
You are in good general health based on your medical history, physical examination, EKG, and screening laboratories.
You are able to understand and sign this informed consent.
You pass the written test called the 'Assessment of Understanding' with a score of at least 80% (8 out of 10 questions correct).

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You agree not to donate blood during the study and for 3 years after the malaria challenge.
You agree not to travel to place(s) where there is malaria during the time of the study.
If you are a female, you must agree to consistently use effective birth control (e.g., oral or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide, abstinence, cervical cap) during the period from the day of screening (today) through 3 months after the malaria challenge.
You must be willing to take anti-malarial treatment after CHMI, if indicated.
You must agree to stay in a pre-determined hotel near the NMRC CTC during the designated post-CHMI follow-up period from approximately 7 days after malaria challenge until antimalarial treatment is completed, if indicated.
If you are an active duty military or federal employee, you must have approval from your supervisory chain to participate. The appropriate approval form will be provided to you.

Who cannot join

You must not have any of the following:
Any history of malaria infection or having been given a malaria vaccine
Any history travel to a country with falciparum malaria in the past 6 months, or planned travel to such an area during the course of the study
Any history of having lived in an area with falciparum malaria for more than 5 years.
Any use of medications that prevent or treat malaria during the 1 month prior to challenge or planned use during the study (outside of the drugs provided by the study team).
Any serious medical illness or condition involving the heart, liver, lungs, or kidneys

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Any significant risk for developing heart disease in the next 5 years. The risk for developing heart disease in the next 5 years will be determined by a combination of the following factors: high blood pressure, smoking, weight, family history of heart disease and the presence of diabetes
Any medical illness or condition involving your blood or immune system (to include sickle cell trait or thalassemia trait)
Any abnormal (as determined by a physician) screening laboratory test results
Any history of neurologic disease (including migraines or seizures)
Any history of psoriasis (itchy skin rash) or porphyria (rare disturbance of metabolism), since these conditions could get worse after treatment with chloroquine (a medication for treating malaria).
You have had your spleen removed
Any past or current infection with HIV, Hepatitis C, or Hepatitis B
Any use of investigational drugs or vaccines within 1 month before starting the study
Any allergy to or inability to take the anti-malaria medications used in this study
Any history of allergic reaction to mosquito bites that required hospitalization
You must not be pregnant or nursing, or have any plans to become pregnant or breastfeed during the period from now through 3 months after malaria challenge
Any chronic use of steroids or other medications that affect the immune system in the 6 months before malaria challenge. Inhaled and topical (used on the skin) steroids are allowed.
You plan to have surgery between enrollment and 3 months after malaria challenge.
Any active alcohol or drug abuse
You have any other physical or psychologic condition or laboratory abnormality that the study doctor thinks may increase your risk of having side effects or compromise the results of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Walter Reed Army Institute of Research
Silver Spring, Maryland, 20910

Other trials in United States

About this study

Official title: Bridging Trial to Evaluate the Infectivity Equivalence of Current and New Lots of Plasmodium Falciparum Strain NF54 (Clone 3D7) Within the WRAIR Controlled Human Malaria Infection (CHMI) Model

Objectives:

Primary:

To characterize the infectivity of the new lot of Plasmodium falciparum strain 3D7 within the standard WRAIR CHMI model as compared to the current lot (historical data)

Secondary:

To assess safety of the new lot of P falciparum parasites
To assess the kinetics of detecting parasitemia and parasite clearance by quantitative polymerase chain reaction (qPCR) as compared to blood smear
To obtain plasma samples to restore the testing control pool for malaria serology testing and for future malaria research

Read the detailed description

This is a single center, open label CHMI study. CHMI will consist of exposure to Plasmodium falciparum sporozoites through the bites of infected mosquitoes. After the challenge, subjects will be evaluated daily for the development of malaria infection using a blood smear. Unless previously diagnosed and fully treated, subjects will be required to stay in a hotel for a maximum of 12 nights starting on or around the evening of Day 7 post challenge.

All subjects diagnosed with malaria infection based on smears will be prescribed a standard malaria treatment regimen to begin on the day that parasitemia is detected. Subjects who do not become parasitemic (via smear) by Day 19 will be empirically treated for malaria.

After the hotel phase, all challenged subjects will have a final scheduled follow-up visit on Day 28 (±7 days).

Conditions: Malaria,Falciparum
Being tested: Plasmodium falciparum malaria parasite
Medical subject headings: Malaria, Falciparum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Plasmodium falciparum malaria parasiteBiological
Laboratory cultured Plasmodium falciparum strain 3D7 delivered via the bite of 5 infected mosquitoes with salivary gland scores of at least 2+ (11-100 sporozoites observed).

Study groups in NCT03882528
Study group	Role	What they receive
Infective controls	Experimental	Controlled Human Malaria Infection (CHMI) will consist of exposure to Plasmodium falciparum sporozoites through the bites of infected mosquitoes. Beginning 5 days after the challenge, subjects will be evaluated daily for the development of malaria infection using a blood smear. Receives: Biological: Plasmodium falciparum malaria parasite

What is being measured

The primary outcome is the main question the study is designed to answer.

To Characterize the Infectivity of a New Lot of Plasmodium Falciparum Strain 3D7 Developing Parasitemia Within the Standard WRAIR CHMI Model.
Number of challenged subjects exposed to the new lot of Plasmodium falciparum strain 3D7 parasites developing parasitemia (defined as 2 unambiguous malaria parasites on a single smear).
Measured: Within 2 weeks

Secondary outcomes (3)

Diagnostic Efficacy; Time to Parasitemia by Blood Smear Method After the P Falciparum Challenge
Time to parasitemia by blood smear method after the P falciparum challenge. Time to parasitemia is defined as the time from CHMI to a first positive malaria parasite result. Parasitemia was defined as the presence of 2 unambiguous malaria parasites on a single smear. Beginning on Day 1 after their challenge, subjects were seen and evaluated daily by a study investigator and blood was drawn for determination of parasitemia by qPCR. Beginning on Day 5 and through Day 19 after their challenge, blood from these daily draws was utilized to generate blood smears to evaluate the development of malaria infection. In addition to smears, subjects were also evaluated for the presence of parasitemia via qPCR. In addition to smears, subjects were also evaluated for the presence of parasitemia via qPCR. However, only blood smears were used for diagnosis during this trial and evaluation of treatment success.
Measured: Within 2-3 weeks
Diagnostic Efficacy; Time to Parasitemia (Days) by qPCR Method After the P Falciparum Challenge
Time to parasitemia by qPCR method after the P falciparum challenge. Time to parasitemia is defined as the time from CHMI to a first positive malaria parasite result. Parasitemia was defined as the presence of 2 unambiguous malaria parasites on a single smear. On Day 0, subjects were evaluated by qPCR once prior to challenge, to establish a baseline. Beginning on Day 1 through Day 19 after their challenge, subjects were seen and evaluated daily by a study investigator and blood was drawn for determination of parasitemia by qPCR. Beginning on Day 5 and going through Day 19 after their challenge, blood from these daily draws was utilized to generate blood smears to evaluate the development of malaria infection. In addition to smears, subjects were also evaluated for the presence of parasitemia via qPCR. However, only blood smears were used for diagnosis during this trial and evaluation of treatment success.
Measured: Within 2-3 weeks
Diagnostic Efficacy; Quantification of Parasite Clearance Time (PCT) by Blood Smear and qPCR Methods After Initiation of Antimalarial Treatment
Time to Clearance was determined for all subjects for both smear and qPCR. Time to Clearance was defined as the time (in Days) from malaria diagnosis to confirmed clearance of parasitemia. Confirmed clearance of parasitemia by malaria smear was defined as the observation of 3 sequential negative (no parasites observed) daily smears. Confirmed clearance of parasitemia by qPCR was defined as 2 sequential daily (approximately 24 hours apart) negative qPCR assay results. For clarity, the day of the final test in each sequence (smear, PCR) was used as the day of confirmed clearance for calculation purposes.
Measured: Within 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Mar 201916 May 2019

First posted20 Mar 2019
Study start4 Mar 2019
Primary completion25 Apr 2019
Study completion16 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Malaria,FalciparumStudies of the same condition, open and under way.
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: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03882528
Sponsor's protocol ID: S-18-02
Status last verified: Mar 2021
First submitted: 24 Oct 2018
Last updated: 30 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bridging Trial to Evaluate the Infectivity Equivalence of Current and New Lots of Plasmodium Falciparum Strain NF54 (Clone 3D7) Within the WRAIR Controlled Human Malaria Infection (CHMI) Model
ClinicalTrials.gov ID: NCT03882528
Acronym / sponsor ID: S-18-02
Conditions: Malaria,Falciparum
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: U.S. Army Medical Research and Development CommandUS federal agency
Study start: 4 Mar 2019 (actual)
Primary completion: 25 Apr 2019 (actual)
Study completion: 16 May 2019 (actual)
First posted: 20 Mar 2019 (actual)
Results: Posted 30 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Objectives:

Primary:

To characterize the infectivity of the new lot of Plasmodium falciparum strain 3D7 within the standard WRAIR CHMI model as compared to the current lot (historical data)

Secondary:

To assess safety of the new lot of P falciparum parasites
To assess the kinetics of detecting parasitemia and parasite clearance by quantitative polymerase chain reaction (qPCR) as compared to blood smear
To obtain plasma samples to restore the testing control pool for malaria serology testing and for future malaria research

Detailed description

After the hotel phase, all challenged subjects will have a final scheduled follow-up visit on Day 28 (±7 days).

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Infective controls	Experimental	Biological: Plasmodium falciparum malaria parasiteControlled Human Malaria Infection (CHMI) will consist of exposure to Plasmodium falciparum sporozoites through the bites of infected mosquitoes. Beginning 5 days after the challenge, subjects will be evaluated daily for the development of malaria infection using a blood smear.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

To be eligible for this study, you must meet ALL of the following conditions:

Key exclusion criteria (21 listed)

You must not have any of the following:

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
Plasmodium falciparum malaria parasiteLaboratory cultured Plasmodium falciparum strain 3D7 delivered via the bite of 5 infected mosquitoes with salivary gland scores of at least 2+ (11-100 sporozoites observed).	Biological	Infective controls

Primary outcome

To Characterize the Infectivity of a New Lot of Plasmodium Falciparum Strain 3D7 Developing Parasitemia Within the Standard WRAIR CHMI Model.
Time frame: Within 2 weeks
Number of challenged subjects exposed to the new lot of Plasmodium falciparum strain 3D7 parasites developing parasitemia (defined as 2 unambiguous malaria parasites on a single smear).

3 secondary outcomes

Diagnostic Efficacy; Time to Parasitemia by Blood Smear Method After the P Falciparum Challenge
Time frame: Within 2-3 weeks
Diagnostic Efficacy; Time to Parasitemia (Days) by qPCR Method After the P Falciparum Challenge
Time frame: Within 2-3 weeks
Diagnostic Efficacy; Quantification of Parasite Clearance Time (PCT) by Blood Smear and qPCR Methods After Initiation of Antimalarial Treatment
Time frame: Within 6 weeks

Results and safety

Results posted to the registry on 30 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Infective Controls	12	12

Primary outcome: To Characterize the Infectivity of a New Lot of Plasmodium Falciparum Strain 3D7 Developing Parasitemia Within the Standard WRAIR CHMI Model.

Time frame: Within 2 weeks. Count of participants. Unit: Participants

Measure	Infective Controls n = 12
9 Days post-challenge	0
10 Days post-challenge	1
11 Days post-challenge	5
12 Days post-challenge	5
13 Days post-challenge	0
14 Days post-challenge	1

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 through Day 35. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infective Controls	0 of 12 (0%)	12 of 12 (100%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

James E Moon, MD principal investigator

Walter Reed Army Institute of Research (WRAIR)

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 Plasmodium falciparum malaria parasite in people with Malaria,Falciparum, run by U.S. Army Medical Research and Development Command 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 12 inclusion and 21 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 30 Mar 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?

Yes. Results are posted in the registry (first posted 30 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

To Characterize the Infectivity of a New Lot of Plasmodium Falciparum Strain 3D7 Developing Parasitemia Within the Standard WRAIR CHMI Model. (time frame: Within 2 weeks). 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 NCT03882528.

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 30 Mar 2021.