NCT05913973

Study of the Plasmodium Vivax Transmission-blocking Vaccine Pvs230D1-EPA/Matrix-M to Assess Safety, Immunogenicity, and Transmission-blocking Activity in Healthy Malaria-naive Adults

Phase 1 Dose Escalation Study of The Plasmodium Vivax Transmission-Blocking Vaccine Pvs230D1-EPA/Matrix-M to Assess Safety, Immunogenicity, and Transmission-Blocking Activity in Healthy Malaria-Naive Adults
National Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Malaria
Drug/Device/Intervention
Pvs230D1-EPA/Matrix-M
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Funder
National Institutes of Health Clinical Center (CC)
Location
Bethesda, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Aug 04, 2023
End date
May 15, 2025
Enrollment
200 participants
Primary outcome

To assess the safety and reactogenicity of Pvs230D1-EPA/MM in healthy malaria-naive adults

Summary

Background:
 
 Malaria is a disease carried by mosquitoes in tropical countries around the world. It can
 cause symptoms like fever, body aches, and weakness. More than half a million people
 worldwide died of malaria in 2021, mostly children. Researchers want to find ways to prevent
 the spread of this disease.
 
 Objective:
 
 To test the effects of a new malaria vaccine. (Volunteers will not be exposed to malaria.)
 
 Eligibility:
 
 Healthy adults aged 18 to 50 years.
 
 Design:
 
 Volunteers will be screened. They will have a physical exam with blood and urine tests. They
 will take a short quiz to make sure they understand the study.
 
 Volunteers will have 3 visits to receive the vaccine. These visits will be about 1 month
 apart. The vaccine will be injected into the muscle of the upper arm.
 
 Volunteers will have 12 additional clinic visits. These will start after the first vaccine
 visit and continue for 8 months. The visits may include a physical exam and blood tests.
 There will also be 7 follow-up phone calls. These will occur the day after each vaccine visit
 and then continue for another 12 months. Participants will be asked how they are doing and
 whether they have had any changes in their health.

ICD-10 classifications
Unspecified malariaPlasmodium malariae malariaPlasmodium falciparum malariaOther parasitologically confirmed malariaPlasmodium ovale malaria
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05913973
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05913973 through Pure Global AI's free database. This Phase 1 trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID) and is currently Recruiting. The study focuses on Malaria. Target enrollment is 200 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.