Plasmodium FalciparumECG-CHMINCT04203186
A Clinical Trial to Evaluate Plasmodium Falciparum 7G8 and NF54 Challenge Strains (PfSPZ) in a Head-to-head Comparative Study - (ECG-CHMI)
A study testing atovaquone-proguanil in people with Plasmodium Falciparum, run by U.S. Army Medical Research and Development Command.
Trial summary
A comparison of Malaria events (symptoms and signs of malaria) experienced by subjects infected with PfSPZ Challenge (NF54) vs. PfSPZ Challenge (7G8). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum
- What is being tested?
- atovaquone-proguanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults (male or non-lactating, non-pregnant female)
- Between the ages of 18 and 45 (inclusive) at the time of enrollment
- Body weight equal to or greater than 110 lbs
- Available and willing to participate for duration of study
- Able and willing to provide a written informed consent
- Able to complete an Assessment of Understanding with a score of at least 80% correct
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- In good general health with no clinically significant health problems as established by medical history, physical examination, and laboratory screening
- Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (Section 5.4.5.3) from 14 days prior to CHMI and agree to continue using such precautions during the study until at least 2 months after CHMI
- If female subjects are unable to bear children due to menopause or have had a procedure performed (e.g. tubal ligation or hysterectomy), a medical note from a physician is required
- If post-menopausal, subjects must have experienced at least 1 year of amenorrhea and provide a medical note from her physician documenting this medical history
- Agree not to travel to a malaria endemic area during the course of the study
- Agree to refrain from blood donation from the time of CHMI and for 3 years following CHMI
- Must be willing to take anti-malarial treatment after CHMI
- Must agree to stay in a pre-determined hotel near the NMRC CTC from approximately 7 days after CHMI until antimalarial treatment is completed or through 18 days post CHMI
- For active-duty military personnel, documentation of their command's approval to participate
Who cannot join
- Pregnant (positive urine pregnancy test) or nursing at screening or plans to become pregnant or nurse at any period from the time of enrollment through 56 days after CHMI.
- Receipt of any investigational malaria vaccine
- Any history of malaria infection
- Travel to a malaria endemic region within 6 months of enrollment or during the study (from enrollment through 2 months after CHMI)
- History of long-term residence (>5 years) in an area known to have significant transmission of P falciparum (http://www.cdc.gov/malaria/map/)
- History of clinically significant contact dermatitis
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- Seropositive for the human immunodeficiency virus (HIV), hepatitis C virus (HCV), and/or hepatitis B surface antigen (HBsAg)
- Positive sickle cell screening test, including evidence of sickle cell trait or sickle cell anemia (due to its effect on subject's susceptibility to malaria)
- History of thalassemia or thalassemia trait (due to its effect on subject's susceptibility to malaria)
- Participation in any clinical study involving another investigational vaccine, drug, or other products within 60 days prior to enrollment or plan to participate in such a clinical study during or within 1 month following the active study phase of the study (from the day enrollment through 2 months after CHMI)
- Allergy to any component of the PfSPZ Challenge formulation, Malarone® (atovaquone-proguanil), and/or Coartem® (artemether-lumefantrine)
- History of porphyria
About this study
Official title: A Phase 1 Clinical Trial To Evaluate The Safety and Infectivity Of Direct Venus Inoculation of Aseptic, Purified, Cryopreserved Plasmodium Falciparum 7G8 And NF54 Challenge Strains (PfSPZ) in a Head-To-Head Comparative Study
A comparison of Malaria events (symptoms and signs of malaria) experienced by subjects infected with PfSPZ Challenge (NF54) vs. PfSPZ Challenge (7G8).
Read the detailed description
The single center study is designed as a double-blind, randomized, placebo-controlled CHMI trial with 2 parallel test groups to directly compare clinical and laboratory characteristics of the NF54 and 7G8 strains of PfSPZ Challenge. This study will also evaluate signatures of and time to parasitemia by multiple methods and evaluate physiologic status data collected by non-invasive wearable monitors before and during Plasmodium falciparum infection to characterize and trend physiologic changes appearing prior to the onset of parasitemia.
PfSPZ Challenge (aseptic, purified, cryopreserved, infectious Plasmodium falciparum sporozoites) or normal saline will be administered by direct venous inoculation (DVI) by 25-gauge needle and syringe to healthy malaria naïve adults.
Data generated from samples collected for biomarker assay analysis will be useful for developing predictive models to evaluate the efficacy of malaria vaccine candidates.
- Conditions
- Plasmodium Falciparum
- Being tested
- atovaquone-proguanil
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atovaquone-proguanilDrug
Also called artemether/lumefantrine (AL; Coartem)
Malaria standard treatment regimen
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - PfSPZ, (NF54) strain | Active comparator | Group 1 (N=9) will receive PfSPZ Challenge (NF54) A one-time dose of 3,200 aseptic, purified, cryopreserved, non-attenuated Plasmodium falciparum (Pf) NF54 sporozoites (Pf SPZ Challenge) Mode of administration: Direct venous inoculation (DVI) through a 25 gauge needle and syringe Receives: Drug: atovaquone-proguanil |
| Group 2 - PfSPZ, (7G8) strain | Active comparator | Group 2 (N=9) will receive PfSPZ Challenge (7G8) A one-time dose of 3,200 aseptic, purified, cryopreserved, non-attenuated Plasmodium falciparum 7G8 sporozoites (Pf SPZ Challenge) Mode of administration: Direct venous inoculation (DVI) through a 25 gauge needle and syringe Receives: Drug: atovaquone-proguanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the pre-patent period
The difference in the time of first malaria event (symptom or sign of malaria),in subjects infected with PfSPZ Challenge (NF54) vs. PfSPZ Challenge (7G8)
Measured: 29 days
Difference in the total number of malaria events
The difference in the total number of Grade 2 or greater malaria events (symptoms and signs of malaria) experienced by subjects infected with PfSPZ Challenge (NF54) vs PfSPZ Challenge (7G8)
Measured: 29 days
Secondary outcomes (2)
Determine differences in pre-patent periods
Determine differences in prepatent periods in subjects infected with PfSPZ Challenge (NF54) vs PfSPZ Challenge (7G8) as detected by TBS, RDT, hsRDT and by PCR
Measured: 29 days
Determine differences in the growth rate of parasites
Determine differences in the growth rate of parasites in the blood of subjects infected by PfSPZ Challenge (NF54) vs PfSPZ Challenge (7G8) as detected by PCR
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study startMar 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: Funding was lost due to the COVID19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 parallel test groups to directly compare clinical and laboratory characteristics
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Naval Medical Research Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203186
- Sponsor's protocol ID
- 19239
- Acronym
- ECG-CHMI
- Status last verified
- May 2020
- First submitted
- 16 Dec 2019
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial To Evaluate The Safety and Infectivity Of Direct Venus Inoculation of Aseptic, Purified, Cryopreserved Plasmodium Falciparum 7G8 And NF54 Challenge Strains (PfSPZ) in a Head-To-Head Comparative Study
- ClinicalTrials.gov ID
- NCT04203186
- Acronym / sponsor ID
- ECG-CHMI / 19239
- Conditions
- Plasmodium Falciparum
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was lost due to the COVID19 Pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Naval Medical Research Center
- Study start
- Mar 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 18 Dec 2019 (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.
A comparison of Malaria events (symptoms and signs of malaria) experienced by subjects infected with PfSPZ Challenge (NF54) vs. PfSPZ Challenge (7G8).
Detailed description
The single center study is designed as a double-blind, randomized, placebo-controlled CHMI trial with 2 parallel test groups to directly compare clinical and laboratory characteristics of the NF54 and 7G8 strains of PfSPZ Challenge. This study will also evaluate signatures of and time to parasitemia by multiple methods and evaluate physiologic status data collected by non-invasive wearable monitors before and during Plasmodium falciparum infection to characterize and trend physiologic changes appearing prior to the onset of parasitemia.
PfSPZ Challenge (aseptic, purified, cryopreserved, infectious Plasmodium falciparum sporozoites) or normal saline will be administered by direct venous inoculation (DVI) by 25-gauge needle and syringe to healthy malaria naïve adults.
Data generated from samples collected for biomarker assay analysis will be useful for developing predictive models to evaluate the efficacy of malaria vaccine candidates.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 2 parallel test groups to directly compare clinical and laboratory characteristics
| Arm | Type | Receives |
|---|---|---|
| Group 1 - PfSPZ, (NF54) strain | Active comparator | Drug: atovaquone-proguanilGroup 1 (N=9) will receive PfSPZ Challenge (NF54) A one-time dose of 3,200 aseptic, purified, cryopreserved, non-attenuated Plasmodium falciparum (Pf) NF54 sporozoites (Pf SPZ Challenge) Mode of administration: Direct venous inoculation (DVI) through a 25 gauge needle and syringe |
| Group 2 - PfSPZ, (7G8) strain | Active comparator | Drug: atovaquone-proguanilGroup 2 (N=9) will receive PfSPZ Challenge (7G8) A one-time dose of 3,200 aseptic, purified, cryopreserved, non-attenuated Plasmodium falciparum 7G8 sporozoites (Pf SPZ Challenge) Mode of administration: Direct venous inoculation (DVI) through a 25 gauge needle and syringe |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Adults (male or non-lactating, non-pregnant female)
- Between the ages of 18 and 45 (inclusive) at the time of enrollment
- Body weight equal to or greater than 110 lbs
- Available and willing to participate for duration of study
- Able and willing to provide a written informed consent
Key exclusion criteria (12 listed)
- Pregnant (positive urine pregnancy test) or nursing at screening or plans to become pregnant or nurse at any period from the time of enrollment through 56 days after CHMI.
- Receipt of any investigational malaria vaccine
- Any history of malaria infection
- Travel to a malaria endemic region within 6 months of enrollment or during the study (from enrollment through 2 months after CHMI)
- History of long-term residence (>5 years) in an area known to have significant transmission of P falciparum (http://www.cdc.gov/malaria/map/)
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 |
|---|---|---|
| atovaquone-proguanilAlso: artemether/lumefantrine (AL; Coartem)Malaria standard treatment regimen | Drug | Group 1 - PfSPZ, (NF54) strain, Group 2 - PfSPZ, (7G8) strain |
Primary outcome
Difference in the pre-patent period
Time frame: 29 days
The difference in the time of first malaria event (symptom or sign of malaria),in subjects infected with PfSPZ Challenge (NF54) vs. PfSPZ Challenge (7G8)
Difference in the total number of malaria events
Time frame: 29 days
The difference in the total number of Grade 2 or greater malaria events (symptoms and signs of malaria) experienced by subjects infected with PfSPZ Challenge (NF54) vs PfSPZ Challenge (7G8)
2 secondary outcomes
Determine differences in pre-patent periods
Time frame: 29 days
Determine differences in the growth rate of parasites
Time frame: 29 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing atovaquone-proguanil in people with Plasmodium Falciparum, run by U.S. Army Medical Research and Development Command.
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 15 inclusion and 12 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: withdrawn, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Difference in the pre-patent period (time frame: 29 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2020.