MalariaNCT00761020
Merozoite Surface Protein 1 Antibody Response in Asymptomatic Human Malaria Infection
A study testing Mefloquine in people with Malaria, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
The main purpose of this trial is to study whether a certain blood test can reliably identify the presence of malaria in people who have been infected with, but who do not have symptoms of malaria. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Mefloquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A male or non-pregnant, non-lactating female 18 to 55 years of age (inclusive) at the time of screening
- Written informed consent obtained from the participant before screening procedures
- Free of clinically significant health problems as established by medical history and clinical examination before entering into the study
- Available to participate for duration of study (approximately 6 months, not including screening period)
- If the participant is female, she must be of non-childbearing potential, (i.e., either surgically sterilized or one year post-menopausal) or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or Depo-Provera®) during this study, have a negative pregnancy test at the time of enrollment, and must agree to continue such precautions for at least two months after completion of the malaria challenge if part of the control cohort, or for three months after the final mefloquine dose is taken if part of the mefloquine cohort.
- Prior to entry into this study, participants must score at least 80% correct on a short multiple-choice quiz that assesses their understanding of this study. If they do not score 80% on the initial quiz, the protocol information will be reviewed with them to ensure comprehension and they will have the opportunity to retest (using the same test). Participants who fail the Comprehension Assessment for the second time will not be enrolled.
Who cannot join
- History of malaria
- Travel to a malarious country within the previous 12 months
- History of participation in a study in which potential exposure to malaria or vaccination against malaria occurred.
- Planned travel to malarious areas during the study period
- History of malaria chemoprophylaxis within 60 days prior to time of study entry
- Recent (defined as any use within 30 days of study entry) or chronic use (defined as more than 14 days of use within 60 days of study entry) of antibiotics with anti-malarial effects (e.g., tetracyclines for dermatologic patients, clindamycin for soft tissue and bone infections, sulfa for recurrent urinary tract infections, etc.)
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- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of study entry. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- Administration of immunoglobulins and/or any blood products within the three months preceding study entry or planned administration during the study period
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
- Personal medical histories including the following diagnoses: systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease, scleroderma, vasculitis, and multiple sclerosis
- Elevated serum creatinine, defined in this study as greater than or equal to 1.7 mg/dL in males and 1.4 mg/dL in females
- Elevated transaminases, defined in this study as greater than twice the upper limit of the normal range (>2 ULN)
- Significant unexplained anemia: hematocrit < 35%
- History of sickle cell disease or sickle cell trait
- Seropositive for hepatitis B surface antigen or hepatitis C antibody
- Hepatomegaly, right upper quadrant abdominal pain or tenderness
- History of splenectomy
- Pregnant or lactating female, or female who intends to become pregnant during the study
- Chronic or active neurologic disorders including seizures, excluding a single febrile seizure as a child
- History of a neuropsychiatric disorder (anxiety, depression, psychosis, schizophrenia, PTSD, etc.)
- Suspected or known current alcohol abuse as defined by the American Psychiatric Association in DSM IV (Diagnostic and Statistical Manual of Mental Disorders- 4th edition)
- Chronic or active illicit and/or intravenous drug use
- History of severe anaphylactic reactions to mosquito bites
- History of allergy to mefloquine
- History of intolerance to mefloquine
- History of psoriasis (given its interaction with chloroquine)
- Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Institute of Research
Silver Spring, Maryland, 20910
About this study
Official title: Analysis of Anti-Plasmodium Falciparum Merozoite Surface Protein 1 Antigen Specific Antibodies in a Human Malaria Challenge Using Mefloquine Prophylaxis to Confirm Assay Sensitivity and Establish Key Antibody Kinetic Parameters
The main purpose of this trial is to study whether a certain blood test can reliably identify the presence of malaria in people who have been infected with, but who do not have symptoms of malaria.
Read the detailed description
In this study, two groups of volunteers will be exposed to malaria through the bites of infected mosquitoes. In one group, volunteers will be given several doses of a drug called mefloquine, known to prevent the development of malaria symptoms. The other group will not be treated with any drug that could prevent symptoms or infection. After exposure, both groups will be monitored for a period of approximately 6 months to see if they develop symptoms of malaria. Any subjects who do so will be treated with appropriate medications. Subjects in both groups will have their blood checked regularly during this period for the presence of a certain malaria antibody called Merozoite Surface Protein 1, or Anti-MSP-1 for short, using a special blood test (also known as an assay). At the completion of the study, the results of all assays will be analyzed to determine if this test can be used to diagnose malaria infection in persons without symptoms.
- Conditions
- Malaria
- Being tested
- Mefloquine, Control
- Keywords
- Malaria, Diagnosis, Biomarker
- Medical subject headings
- Malaria, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MefloquineDrug
Also called Lariam
To determine the seroconversion rate (sensitivity) to Plasmodium falciparum Merozoite Surface Protein 1 (Pf MSP-1) antigen by ELISA assay in the infectivity control and mefloquine cohorts as part of a larger project to support the qualification of anti-MSP-1 antigen-specific antibody assays as valid surrogate endpoints for malaria infection.
ControlOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Mefloquine | Experimental | Mefloquine 250 mg orally daily x 3 days beginning 2 days prior to challenge and then weekly for 4 weeks post challenge. Receives: Drug: Mefloquine |
| Control | Sham comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects showing four-fold increase in antibody titer
The focus of the statistical analysis will be to estimate (with 95% confidence limits) the sensitivity of Pf assay in the mefloquine and control arms. Sensitivity will be calculated as the number of subjects in each cohort who develop at least a four-fold increase in antibody titer from baseline (measured positives) divided by the number infected (true positives). The binomial test will used to test the null hypothesis that the sensitivity in the mefloquine arm is at 30% α(= 0.05; one-sided). The control group will serve as a check on the challenge. The study is not powered to statistically test for a difference in sensitivity between mefloquine and control arms. ELISA titer data will be log-transformed for all analyses. For each group, geometric mean anti-MSP-1 antibody titers with 95% confidence intervals will be determined by ELISA and tabulated at each time point which blood samples are taken for serology.
Measured: 1 year
Secondary outcomes (1)
Subjects showing Anti- Pf MSP-1 IgG antibody response
The focus of the statistical analysis will be to characterize the antibody kinetics in subjects over that time, will be presented graphically in whole blood concentration vs. time plots. We will identify individual Cmax, t 1/2, and time to Cmax as well determined point estimates and confidence intervals for the cohorts. We will also estimate the percentage cross-reactivity of the serum in each cohort by measuring the number of subjects who test Pf assay positive divided by the number of subjects Pf infected with in each cohort.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
- Investigators
- James Moon, MD, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761020
- Sponsor's protocol ID
- WRAIR 1490
- Other IDs
- HSRRB Log#A-15136
- Status last verified
- Apr 2021
- First submitted
- 25 Sep 2008
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Anti-Plasmodium Falciparum Merozoite Surface Protein 1 Antigen Specific Antibodies in a Human Malaria Challenge Using Mefloquine Prophylaxis to Confirm Assay Sensitivity and Establish Key Antibody Kinetic Parameters
- ClinicalTrials.gov ID
- NCT00761020
- Acronym / sponsor ID
- WRAIR 1490
- Conditions
- Malaria
- Keywords
- Malaria, Diagnosis, Biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Study start
- Sep 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Sep 2008 (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.
The main purpose of this trial is to study whether a certain blood test can reliably identify the presence of malaria in people who have been infected with, but who do not have symptoms of malaria.
Detailed description
In this study, two groups of volunteers will be exposed to malaria through the bites of infected mosquitoes. In one group, volunteers will be given several doses of a drug called mefloquine, known to prevent the development of malaria symptoms. The other group will not be treated with any drug that could prevent symptoms or infection. After exposure, both groups will be monitored for a period of approximately 6 months to see if they develop symptoms of malaria. Any subjects who do so will be treated with appropriate medications. Subjects in both groups will have their blood checked regularly during this period for the presence of a certain malaria antibody called Merozoite Surface Protein 1, or Anti-MSP-1 for short, using a special blood test (also known as an assay). At the completion of the study, the results of all assays will be analyzed to determine if this test can be used to diagnose malaria infection in persons without symptoms.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mefloquine | Experimental | Drug: MefloquineMefloquine 250 mg orally daily x 3 days beginning 2 days prior to challenge and then weekly for 4 weeks post challenge. |
| Control | Sham comparator | Other: Control |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A male or non-pregnant, non-lactating female 18 to 55 years of age (inclusive) at the time of screening
- Written informed consent obtained from the participant before screening procedures
- Free of clinically significant health problems as established by medical history and clinical examination before entering into the study
- Available to participate for duration of study (approximately 6 months, not including screening period)
- If the participant is female, she must be of non-childbearing potential, (i.e., either surgically sterilized or one year post-menopausal) or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or Depo-Provera®) during this study, have a negative pregnancy test at the time of enrollment, and must agree to continue such precautions for at least two months after completion of the malaria challenge if part of the control cohort, or for three months after the final mefloquine dose is taken if part of the mefloquine cohort.
Key exclusion criteria (28 listed)
- History of malaria
- Travel to a malarious country within the previous 12 months
- History of participation in a study in which potential exposure to malaria or vaccination against malaria occurred.
- Planned travel to malarious areas during the study period
- History of malaria chemoprophylaxis within 60 days prior to time of study entry
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 |
|---|---|---|
| MefloquineAlso: LariamTo determine the seroconversion rate (sensitivity) to Plasmodium falciparum Merozoite Surface Protein 1 (Pf MSP-1) antigen by ELISA assay in the infectivity control and mefloquine cohorts as part of a larger project to support the qualification of anti-MSP-1 antigen-specific antibody assays as valid surrogate endpoints for malaria infection. | Drug | Mefloquine |
| ControlNo Intervention | Other | Control |
Primary outcome
Subjects showing four-fold increase in antibody titer
Time frame: 1 year
The focus of the statistical analysis will be to estimate (with 95% confidence limits) the sensitivity of Pf assay in the mefloquine and control arms. Sensitivity will be calculated as the number of subjects in each cohort who develop at least a four-fold increase in antibody titer from baseline (measured positives) divided by the number infected (true positives). The binomial test will used to test the null hypothesis that the sensitivity in the mefloquine arm is at 30% α(= 0.05; one-sided). The control group will serve as a check on the challenge. The study is not powered to statistically test for a difference in sensitivity between mefloquine and control arms. ELISA titer data will be log-transformed for all analyses. For each group, geometric mean anti-MSP-1 antibody titers with 95% confidence intervals will be determined by ELISA and tabulated at each time point which blood samples are taken for serology.
1 secondary outcome
Subjects showing Anti- Pf MSP-1 IgG antibody response
Time frame: 1 year
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 19 Apr 2021.
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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 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 study testing Mefloquine in people with Malaria, 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 6 inclusion and 28 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 19 Apr 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. 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.
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?
Subjects showing four-fold increase in antibody titer (time frame: 1 year). 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 19 Apr 2021.