A Trial For The Study of Falciparum Malaria Protein 014 Administered Via Intramuscular Injection in Healthy Adults

Phase 1

Waitlist Available

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

No Placebo-Only Group

Summary

This trial will study the safety and effectiveness of a new malaria vaccine.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 505 days (+/- 14) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess expected immunological response associated with Candidate Malaria Vaccine FMP014/ALFQ

Safety Dosage of Candidate Malaria Vaccine FMP014/ALFQ

Secondary study objectives

Determine the number of days before Plasmodium falciparum infection in controlled humans vaccinated with FMP014/ALFQ

Measure (Qualitative) Immune Responses to CSP, induced by FMP014/ALFQ using various immunoassays.

Measure (Quantitative) Immune Responses to CSP, induced by FMP014/ALFQ using various immunoassays.

Other study objectives

Compare the efficacy of standard, delayed dosing, and delayed fractional dosing: Proportion of vaccinated subjects without P. falciparum parasitemia

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 FMP014 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 FMP014 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 FMP014 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 FMP014 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 FMP014 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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