Pure Global

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 - Trial NCT05913973

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.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT05913973
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05913973
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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

Study Focus

Malaria

Pvs230D1-EPA/Matrix-M

Interventional

drug

Sponsor & Location

National Institute of Allergy and Infectious Diseases (NIAID)

National Institutes of Health Clinical Center (CC)

Bethesda, United States of America

Timeline & Enrollment

Phase 1

Aug 04, 2023

May 15, 2025

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 malaria
Plasmodium malariae malaria
Plasmodium falciparum malaria
Other parasitologically confirmed malaria
Plasmodium ovale malaria

Data Source

ClinicalTrials.gov

NCT05913973

Non-Device Trial