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Virus Therapy

Part A - "Low" Dose for Vaccine Reaction

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
Healthy adults between the ages 18-55 (inclusive);
Able and willing to provide written, informed consent;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 505 days (+/- 14)
Awards & highlights

Study Summary

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

Eligible Conditions
  • Vaccine Reaction

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess expected immunological response associated with Candidate Malaria Vaccine FMP014/ALFQ
Safety Dosage of Candidate Malaria Vaccine FMP014/ALFQ
Secondary outcome measures
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 outcome measures
Compare the efficacy of standard, delayed dosing, and delayed fractional dosing: Proportion of vaccinated subjects without P. falciparum parasitemia

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.

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~9 spots leftby Mar 2025