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

Completed Phase 1 Last updated 1 December 2025

What this trial tests

Phase 1 trial testing Pvs230D1-EPA/Matrix-M in Malaria in 105 participants. Completed in 12 November 2025.

Timeline

4 August 2023

Primary endpoint
12 November 2025

12 November 2025

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	105
Start date	4 August 2023
Primary completion	12 November 2025
Estimated completion	12 November 2025
Sites	1 location across United States

Drugs / interventions tested

• Pvs230D1-EPA/Matrix-M — full drug profile →

Conditions studied

• Malaria — all drugs for Malaria →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 50, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

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Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vaccines and monoclonal antibodies: new tools for malaria control.
   Miura K, Flores-Garcia Y, Long CA, Zavala F. · · 2024 · cited 24× · PMID 38656211 · DOI 10.1128/cmr.00071-23
2. A new landscape for malaria vaccine development.
   Laurenson AJ, Laurens MB. · · 2024 · cited 6× · PMID 38935630 · DOI 10.1371/journal.ppat.1012309
3. Distinct immunogenicity outcomes of DNA vaccines encoding malaria transmission-blocking vaccine target antigens Pfs230D1M and Pvs230D1.
   Cao Y, da Silva Araujo M, Lorang CG, Dos Santos NAC, et al · · 2025 · cited 4× · PMID 39787798 · DOI 10.1016/j.vaccine.2024.126696