Group 1b: PfSPZ Vaccine for Malaria

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Malaria+2 More
PfSPZ Vaccine - Biological
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

USSPZV7 is a randomized, phase 1, double-blind, placebo-controlled trial of Sanaria® PfSPZ Vaccine administered on Days 1, 8 and 29 by direct venous inoculation (DVI) to assess safety, tolerability, immunogenicity, and vaccine efficacy (VE) against heterologous controlled human malaria infection (CHMI) with the 7G8 clone of Plasmodium falciparum (Pf) conducted at 3 or 12 weeks after the third immunization. The trial is designed to determine if individuals living in a non-malaria endemic area such as the United States (US) are protected against heterologous CHMI conducted at these time points.

Eligible Conditions
  • Malaria

Treatment Effectiveness

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Pre vaccination 1 to Day 141

Day 28
VE for CHMI at 3 weeks
Day 28
VE for CHMI at 12 weeks
Day 28
Vaccines
Day 28
Adverse events
Day 141
Antibody levels to PfCSP measured by ELISA

Trial Safety

Trial Design

6 Treatment Groups

Group 1b: PfSPZ Vaccine
1 of 6
Group 1a: PfSPZ Vaccine
1 of 6
Group 1: PfSPZ Vaccine
1 of 6
Group 2a: Normal Saline Controls
1 of 6
Group 2b: Normal Saline Controls
1 of 6
Group 2: Normal Saline Controls
1 of 6
Active Control
Non-Treatment Group

60 Total Participants · 6 Treatment Groups

Primary Treatment: Group 1b: PfSPZ Vaccine · Has Placebo Group · Phase 1

Group 2a: Normal Saline ControlsPlaceboComparator Group · 2 Interventions: PfSPZ Challenge (7G8), Normal Saline · Intervention Types: Biological, Other
Group 2b: Normal Saline ControlsPlaceboComparator Group · 2 Interventions: PfSPZ Challenge (7G8), Normal Saline · Intervention Types: Biological, Other
Group 1b: PfSPZ VaccineActiveComparator Group · 2 Interventions: PfSPZ Vaccine, PfSPZ Challenge (7G8) · Intervention Types: Biological, Biological
Group 1a: PfSPZ VaccineActiveComparator Group · 2 Interventions: PfSPZ Vaccine, PfSPZ Challenge (7G8) · Intervention Types: Biological, Biological
Group 1: PfSPZ VaccineActiveComparator Group · 2 Interventions: PfSPZ Vaccine, PfSPZ Challenge (7G8) · Intervention Types: Biological, Biological
Group 2: Normal Saline ControlsPlaceboComparator Group · 2 Interventions: PfSPZ Challenge (7G8), Normal Saline · Intervention Types: Biological, Other

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre vaccination 1 to day 141

Who is running the clinical trial?

Sanaria Inc.Lead Sponsor
35 Previous Clinical Trials
3,501 Total Patients Enrolled
35 Trials studying Malaria
3,501 Patients Enrolled for Malaria
University of Maryland, BaltimoreOTHER
599 Previous Clinical Trials
332,655 Total Patients Enrolled
4 Trials studying Malaria
1,893 Patients Enrolled for Malaria
Kirsten E Lyke, MDPrincipal InvestigatorUniversity of Maryland, Baltimore
1 Previous Clinical Trials
72 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are of childbearing potential and agree to use effective means of birth control (e.g.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: October 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.