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Virus Therapy
FMP013 for Malaria
Phase 1
Recruiting
Research Sponsored by U.S. Army Medical Research and Development Command
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 505 days (+/-14)
Awards & highlights
Study Summary
This trial is testing a new malaria vaccine in healthy adults to see if it is safe, effective, and tolerated.
Eligible Conditions
- Vaccine Reaction
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 505 days (+/-14)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~505 days (+/-14)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess Reactogenicity of Candidate Malaria Vaccine FMP013/ALFQ
Safety Dosage of Candidate Malaria Vaccine FMP013/ALFQ
Secondary outcome measures
Determine the Protective Efficacy of FMP013/ALFQ against a Plasmodium falciparum controlled human malaria infection.
Measure Immune Responses to CSP, induced by FMP013/ALFQ using various immunoassays.
Other outcome measures
Compare the efficacy of standard, delayed dosing, and delayed fractional dosing
Trial Design
6Treatment groups
Active Control
Group I: Part A - "Low" DoseActive Control2 Interventions
Part A vaccinees in the "low dose" arm will receive the lower dosing (20 μg FMP013 per 0.5 mL ALFQ) approximately 2 weeks prior to each vaccination. Vaccination to be delivered on 0,1,2 month.
Group II: Part A - "High" DoseActive Control2 Interventions
Part A vaccinees in the "high dose" arm will receive the lower dosing (40 μg FMP013 per 1.0 mL ALFQ) approximately 2 weeks prior to each vaccination.
Vaccination to be delivered on 0,1,2 month.
Group III: Part B - "Standard" DoseActive Control2 Interventions
Part B vaccinees in the "high dose" arm will receive the lower dosing (40 μg FMP013 per 1.0 mL ALFQ) approximately 2 weeks prior to each vaccination.
Vaccination to be delivered on 4,5,6 month.
Group IV: Part B - "Delayed" DoseActive Control2 Interventions
Part B vaccinees in the "high dose" arm will receive the lower dosing (40 μg FMP013 per 1.0 mL ALFQ) approximately 2 weeks prior to each vaccination.
Vaccination to be delivered on 0,1,6 month.
Group V: Part B - "Delayed Fractional" DoseActive Control2 Interventions
Part B vaccinees in the "high dose" arm will receive the lower dosing (40 μg FMP013 per 1.0 mL ALFQ) approximately 2 weeks prior to each vaccination.
Vaccination to be delivered on 0,1,6 month.
Group VI: ControlActive Control1 Intervention
Up to 6 subjects will be enrolled (defined as receiving malaria challenge) later in the trial to serve as challenge controls. Additional subjects may be recruited as alternates to ensure that 6 control subjects undergo the challenge. Any alternates not challenged will be released from the study at day of challenge.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
U.S. Army Medical Research and Development CommandLead Sponsor
285 Previous Clinical Trials
245,113 Total Patients Enrolled
1 Trials studying Vaccine Reaction
46 Patients Enrolled for Vaccine Reaction
Walter Reed Army Institute of Research (WRAIR)FED
107 Previous Clinical Trials
36,718 Total Patients Enrolled
1 Trials studying Vaccine Reaction
46 Patients Enrolled for Vaccine Reaction
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are a healthy adult aged between 18 and 55 years old.You are able and willing to follow all the instructions given by the research team, according to the investigator's judgment.Your white blood cell count falls within a range of 3,800 to 10,800 cells per cubic millimeter.Your platelet count falls within the range of 140,000-400,000 per cubic millimeter.You have a past medical history of an autoimmune disease.You have a severe allergy to mosquito bites that has required hospitalization.You have a history of swelling disorder called Angioedema, which can be hereditary or acquired without a known cause.You had unexplained hives within the last year.You have received a malaria vaccine in the past.You have experienced severe allergic reactions in the past.You are allergic to all three anti-malarial medications proposed for use in the trial.You have any condition, illness, or issue that could make it risky for you to participate in the study, could affect your ability to understand what the study involves or could affect the accuracy of the study results according to the investigator.You have a history of ongoing or long-term neurological conditions such as seizures or chronic migraines.You must use birth control during the study.You have recently traveled to or plan to travel to areas where malaria is common during the study period.You have a history of arthritis other than osteoarthritis.You have a history of psoriasis or porphyria.You have a serious medical condition that affects your heart, liver, lungs, or kidneys.You have had uncontrolled asthma or needed emergency medical attention for asthma in the past two years.You must have a negative HIV test before you can participate in the study.You have taken medication to prevent or treat malaria within the last month or plan to take it during the study.You have a medical history of sickle cell disease or trait, or any condition that may increase your risk of getting malaria.You have a history of drug or alcohol abuse.You have had your spleen removed in the past.You agree to take medicine that prevents malaria after being infected with it in the study.You have had malaria before or have lived in a place where malaria is common for more than 5 years.You have a history of thyroid disease, except for hypothyroidism that is well controlled.You are capable of reading and signing a document that explains the study and gives permission to participate.Your hemoglobin levels must be at least 11.7 g/dL if you're a woman and 12.0 g/dL if you're a man.Your kidney function, as measured by serum creatinine, must be within a certain range (less than or equal to 1.5 mg/dL).You cannot donate blood while participating in the study, and if you undergo a specific type of infection simulation for research, you cannot donate blood to the American Red Cross for at least 3 years after the simulation.Your ALT levels must be within a certain range: between 9-46 U/L for males and 6-29 U/L for females.You are currently receiving treatment or preventative medication for tuberculosis.You have taken immunosuppressive, cytotoxic medications or immunomodulators within the past 12 weeks. You have received live attenuated vaccines in the past 30 days or plan to receive them within 14 days before or after the study vaccine. You have taken medication for malaria within the past month or plan to take medically indicated subunit or killed vaccines around the time of the study vaccine.You have been diagnosed with other rheumatoid disorders in the past.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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