A Phase 1 Trial of PfSPZ Vaccine in Healthy Adults to Determine Safety, Tolerability and Efficacy Against Heterologous CHMI

Phase 1

Waitlist Available

Led By Kirsten E Lyke, MD

Research Sponsored by Sanaria Inc.

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 pre vaccination 1 to day 141

Summary

This trial tests a malaria vaccine on healthy adults in the US to see if it can protect them. The vaccine trains the immune system using a weakened malaria parasite. Using weakened parasites has been the most effective method to protect against malaria infection in previous studies.

Eligible Conditions

Malaria caused by Plasmodium falciparum
Malaria

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre vaccination 1 to day 141

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre vaccination 1 to day 141

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre vaccination 1 to day 141 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse Events

Secondary study objectives

Antibody levels to PfCSP measured by ELISA

VE for CHMI at 12 weeks

VE for CHMI at 3 weeks

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Group 1a: PfSPZ VaccineActive Control2 Interventions

45 participants will receive 3 doses of 9.0x10\^5 PfSPZ Vaccine on Days 1, 8, and 29 with a total dose of 2.7x10\^6 PfSPZ Vaccine. Group 1a: Approximately half (22/23) of the volunteers will undergo CHMI 3 weeks after last immunization by exposure to 3.2x10\^3 PfSPZ Challenge (7G8).

Group II: Group 1b: PfSPZ VaccineActive Control2 Interventions

45 participants will receive 3 doses of 9.0x10\^5 PfSPZ Vaccine on Days 1, 8, and 29 with a total dose of 2.7x10\^6 PfSPZ Vaccine. Group 1b: Approximately half (22/23) of the volunteers will undergo CHMI 12 weeks after last immunization by exposure to 3.2x10\^3 PfSPZ Challenge (7G8).

Group III: Group 2a: Normal Saline ControlsPlacebo Group2 Interventions

15 participants will receive 3 doses of normal saline on Days 1, 8, and 29. Group 2a: Approximately half (7/8) of the volunteers will undergo CHMI 3 weeks after last immunization by exposure to 3.2x10\^3 PfSPZ Challenge (7G8).

Group IV: Group 2b: Normal Saline ControlsPlacebo Group2 Interventions

15 participants will receive 3 doses of normal saline on Days 1, 8, and 29. Group 2b: Approximately half (7/8) of the volunteers will undergo CHMI 12 weeks after last immunization by exposure to 3.2x10\^3 PfSPZ Challenge (7G8).

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