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Virus Therapy

HMPBS02-Pv for Malaria

Phase 1
Waitlist Available
Led By Patrick E Duffy, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
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 time of enrollment until blood collection for blood-stage parasite bank (10-11 days post-infection)
Awards & highlights

Study Summary

This study is evaluating whether a malaria infection can be used to infect people with malaria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of enrollment until blood collection for blood-stage parasite bank (10-11 days post-infection)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time of enrollment until blood collection for blood-stage parasite bank (10-11 days post-infection) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
P. Vivax Blood Collection
Secondary outcome measures
safety and tolerability

Side effects data

From 2022 Phase 1 trial • 2 Patients • NCT05095272
100%
Alanine aminotransferase increased
100%
Aspartate aminotransferase increased
100%
Platelet count decreased
100%
Myalgia
100%
Fatigue
100%
Headache
100%
Lymphocyte count decreased
100%
Malaise
50%
Neutrophil count decreased
50%
Chills
50%
Chest discomfort
50%
Nausea
50%
Pyrexia
50%
Tachycardia
50%
White blood cell count decreased
50%
Proteinuria
50%
Haemoglobin decreased
50%
Leukopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Healthy Malaria-naive US Adults Between 18 and 50 Years of Age

Trial Design

1Treatment groups
Experimental Treatment
Group I: Healthy malaria-naive US adultsExperimental Treatment1 Intervention
A single dose of cryopreserved inoculum containing blood-stage P. vivax will be administered IV
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HMPBS02-Pv
2022
Completed Phase 1
~10

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,467 Total Patients Enrolled
149 Trials studying Malaria
612,654 Patients Enrolled for Malaria
Patrick E Duffy, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
13 Previous Clinical Trials
24,322 Total Patients Enrolled
13 Trials studying Malaria
24,322 Patients Enrolled for Malaria

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
PLOS Neglected Tropical DiseasesJournal
Safety and Reproducibility of a Clinical Trial System Using Induced Blood Stage Plasmodium Vivax Infection and Its Potential as a Model to Evaluate Malaria Transmission
Griffin, Paul, Cielo Pasay, Suzanne Elliott, Silvana Sekuloski, Maggy Sikulu, Leon Hugo, David Khoury, et al.. 2016. “Safety and Reproducibility of a Clinical Trial System Using Induced Blood Stage Plasmodium Vivax Infection and Its Potential as a Model to Evaluate Malaria Transmission”. Edited by Photini Sinnis. PLOS Neglected Tropical Diseases. Public Library of Science (PLoS). doi:10.1371/journal.pntd.0005139.
The Journal of Infectious DiseasesJournal
Experimentally Induced Blood-stage Plasmodium Vivax Infection in Healthy Volunteers
McCarthy, James S., Paul M. Griffin, Silvana Sekuloski, A. Taylor Bright, Rebecca Rockett, David Looke, Suzanne Elliott, et al.. 2013. “Experimentally Induced Blood-stage Plasmodium Vivax Infection in Healthy Volunteers”. The Journal of Infectious Diseases. Oxford University Press (OUP). doi:10.1093/infdis/jit394.
Journal of Clinical InvestigationJournal
A Plasmodium Vivax Experimental Human Infection Model for Evaluating Efficacy of Interventions
Collins, Katharine A., Claire Y.T. Wang, Matthew Adams, Hayley Mitchell, Greg J. Robinson, Melanie Rampton, Suzanne Elliott, et al.. 2020. “A Plasmodium Vivax Experimental Human Infection Model for Evaluating Efficacy of Interventions”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci134923.
clinicaltrials.govStudy
Blood-Stage Plasmodium Vivax Cell Bank
2022. "Blood-Stage Plasmodium Vivax Cell Bank". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05095272.
~1 spots leftby Apr 2025
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