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Virus Therapy

Group 1a: PfSPZ Vaccine for Malaria

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
Awards & highlights

Study Summary

This trial tests the safety, effectiveness, and immunological response of a new malaria vaccine administered in the US to prevent malaria infection.

Eligible Conditions
  • Malaria caused by Plasmodium falciparum
  • Malaria

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events
Vaccines
Secondary outcome measures
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).

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sanaria Inc.Lead Sponsor
35 Previous Clinical Trials
3,523 Total Patients Enrolled
35 Trials studying Malaria
3,523 Patients Enrolled for Malaria
University of Maryland, BaltimoreOTHER
687 Previous Clinical Trials
374,586 Total Patients Enrolled
6 Trials studying Malaria
2,584 Patients Enrolled for Malaria
Kirsten E Lyke, MDPrincipal InvestigatorUniversity of Maryland, Baltimore
1 Previous Clinical Trials
72 Total Patients Enrolled

Media Library

PfSPZ Vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05604521 — Phase 1
Malaria Research Study Groups: Group 1a: PfSPZ Vaccine, Group 1b: PfSPZ Vaccine, Group 2a: Normal Saline Controls, Group 2b: Normal Saline Controls
Malaria Clinical Trial 2023: PfSPZ Vaccine Highlights & Side Effects. Trial Name: NCT05604521 — Phase 1
PfSPZ Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05604521 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is considered an optimal candidate for this experimental program?

"This clinical trial will accept 60 individuals aged 18-50 with a diagnosis of malaria. Participants must also fulfill the following conditions: Be in good health, consent to involvement for the entirety of the investigation, pass an understanding test with a score higher than 80%, have no significant physical/laboratory abnormalities, women eligible for childbearing should use reliable contraception throughout and abstain from donating blood for 3 years post completion, agree not to travel to any malarial area during this time."

Answered by AI

Is there any potential hazard associated with Group 1a: PfSPZ Vaccine for participants?

"Considering the Phase 1 nature of this trial, with only a small amount of data to support both safety and efficacy, Group 1a: PfSPZ Vaccine received an assessment score of 1."

Answered by AI

How many participants are currently taking part in this trial?

"Indeed, the data hosted on clinicaltrials.gov verifies that this medical research project is currently recruiting patients. It was first released to the public on October 25th 2022 and has since been updated - most recently on November 2nd 2022. This trial seeks to enroll 60 people from a single location."

Answered by AI

Is there a recruitment period currently underway for participants in this experiment?

"Affirmative. According to the information from clinicaltrials.gov, this research protocol is actively looking for enrolment and was initially posted on October 25th 2022; it has since been updated as recently as November 2nd 2022. 60 prospective participants are needed at a single site."

Answered by AI

Do the eligibility requirements of this trial extend to individuals aged 18 or older?

"This trial is recruiting those aged 18 to 50 and separate trials are being conducted for the under-18s (70) and over 65s (35)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 1 Trial of PfSPZ Vaccine in Healthy Adults to Determine Safety, Tolerability and Efficacy Against Heterologous CHMI
2022. "A Phase 1 Trial of PfSPZ Vaccine in Healthy Adults to Determine Safety, Tolerability and Efficacy Against Heterologous CHMI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05604521.
~26 spots leftby Apr 2025
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