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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT05913973•National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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. ...

Detailed Description

Study Description: Single-center, open-label, first-in-human, dose-escalating phase 1 study to characterize the safety, immunogenicity, and transmission-blocking activity in healthy malaria-naive adults of the Plasmodium vivax (P. vivax) transmission-blocking vaccine (TBV), Pvs230D1-EPA combined with adjuvant Matrix-M (MM). Three doses of vaccine will be administered at 1-month intervals (study days 0, 28, and 56). Subjects will be divided into low, intermediate, and high dose groups based on the amount of the antigen component in each vaccine dose: * Group 1 (n = 10): 5 (micro)g Pvs230D1-EPA/50 (micro)g MM * Group 2 (n = 10): 25 (micro)g Pvs230D1-EPA/50 (micro)g MM * Group 3 (n = 10): 50 (micro)g Pvs230D1-EPA/50 (micro)g MM Objectives: Primary Objective -To assess the safety and reactogenicity of Pvs230D1-EPA/MM in healthy malaria-naive adults Exploratory Objectives * To determine the antibody response to Pvs230D1-EPA/MM * To determine the functional response to Pvs230D1-EPA/MM by mosquito feeding assays * To assess cellular and transcriptomic responses to Pvs230D1-EPA/MM * To identify and characterize human monoclonal antibodies (mAbs) with activity against Pvs230D1M Endpoints: Primary Endpoint -Incidence and severity of local and systemic adverse events (AEs) or serious adverse events (SAEs) Exploratory Endpoints * Anti-Pvs230D1M antibody levels as measured by enzyme-linked immunosorbent assay (ELISA) * Transmission-reducing activity (TRA) and/or transmission-blocking activity (TBA) of Pvs230D1-EPA/MM using direct membrane feeding assays (DMFA) * Cellular immune responses and whole genome transcriptional profiles * Isolation of reactive antibodies from sorted B cells

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All of the following criteria must be fulfilled for a subject to participate in this trial:
•1. Age \>=18 and \<=50 years.
•2. In good general health and without clinically significant medical history.
•3. Able to sign a written informed consent prior to undertaking any study-related procedure.
•4. Vaccine comprehension exam completed, passed (a score of (Bullet)80% or per investigator s discretion), and reviewed prior to enrollment.
•5. Suitable accommodation and reliable access to the NIHCC for the duration of the study, in the opinion of the investigator.
•6. Individuals of childbearing potential must agree to use an acceptable method of contraception from 1 month prior to enrollment to 1 month after the final vaccination (i.e., from study day -28 until study day 84).
•7. Individuals capable of fathering children must agree to use an acceptable method of contraception from 1 month prior to enrollment to 1 month after the final vaccination (i.e., from study day -28 until study day 84).
•8. Willing to allow long-term storage of study samples for future research.
•9. Willing to refrain from donating blood throughout the study until 6 months after the last vaccination.

Exclusion Criteria

•A subject will be excluded from participating in this trial if any 1 of the following criteria is fulfilled:
•1. Planned travel to a malaria-endemic area until 6-months beyond the final vaccination (see https://www.cdc.gov/malaria/travelers/country\_table/a.html). Exceptions may be made, at the investigator s discretion, if the travel is limited to areas without appreciable levels of P. vivax transmission.
•2. Any prior confirmed P. vivax malaria diagnosis or clinical history consistent with P. vivax malaria diagnosis within the previous 10 years, at the investigator's discretion.
•3. Any subject without good peripheral venous access, at the investigator's discretion.
•4. For individuals of childbearing potential:
•1. Currently breastfeeding.
•2. Currently pregnant as determined by history or a positive human choriogonadotropin (beta-hCG) test.
•5. Clinical trial staff with direct involvement in the conduct of the trial are excluded from participation.
•6. HIV, hepatitis B, and/or hepatitis C as determined by HIV antigen/antibody, Hepatitis B surface antigen, and anti-Hepatitis C antibody laboratory tests.
•7. Screening blood test or urinalysis laboratory parameters outside of local lab normal range. Subjects may be included at the investigator s discretion for "not clinically significant" values outside of normal range.
+11 more criteria

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Key Dates

Start Date

August 4, 2023

Primary Completion Date

November 12, 2025

Completion Date

November 12, 2025

Last Updated

December 1, 2025

Enrollment

105

ACTUAL participants

Conditions

Malaria

Interventions

Pvs230D1-EPA/Matrix-M

DRUG

Dose Finding Trial of R21/Matrix-M in School Children

NCT07074665

Malaria (Plasmodium Falciparum)

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RECRUITINGPHASE4

OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa

NCT06967519

MalariaHiv

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RECRUITING

Introduction of Polymerase Chain Reaction (PCR) in Microbiology and Parasitology

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Dose Finding Trial of R21/Matrix-M in School Children

OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa

Introduction of Polymerase Chain Reaction (PCR) in Microbiology and Parasitology

FocaL Mass Drug Administration for Vivax Malaria Elimination

A Study of Oral E1018 in Healthy Adult Participants

Laboratory Evaluation of Pregnancy Malaria Vaccine Candidates/In-vitro Testing of Pregnancy Malaria Vaccine Candidates