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MalariaPhase 1NCT05913973

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

A Phase 1 study testing Pvs230D1-EPA/Matrix-M in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Malaria
What is being tested?
Pvs230D1-EPA/Matrix-M
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteUnited States
Study dates
4 Aug 2023to 12 Nov 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • All of the following criteria must be fulfilled for a subject to participate in this trial:
  • Age >=18 and <=50 years.
  • In good general health and without clinically significant medical history.
  • Able to sign a written informed consent prior to undertaking any study-related procedure.
  • Vaccine comprehension exam completed, passed (a score of (Bullet)80% or per investigator s discretion), and reviewed prior to enrollment.
  • Suitable accommodation and reliable access to the NIHCC for the duration of the study, in the opinion of the investigator.
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  • 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).
  • 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).
  • Willing to allow long-term storage of study samples for future research.
  • Willing to refrain from donating blood throughout the study until 6 months after the last vaccination.

Who cannot join

  • A subject will be excluded from participating in this trial if any 1 of the following criteria is fulfilled:
  • 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.
  • 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.
  • Any subject without good peripheral venous access, at the investigator's discretion.
  • For individuals of childbearing potential:
  • Currently breastfeeding.
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  • Currently pregnant as determined by history or a positive human choriogonadotropin (beta-hCG) test.
  • Clinical trial staff with direct involvement in the conduct of the trial are excluded from participation.
  • HIV, hepatitis B, and/or hepatitis C as determined by HIV antigen/antibody, Hepatitis B surface antigen, and anti-Hepatitis C antibody laboratory tests.
  • 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.
  • History of anaphylaxis, severe allergy, or other concerning adverse reaction, in the opinion of the investigator, to a previous vaccine.
  • Any of the following within the specified periods:
  • Investigational P. vivax malaria vaccine within the last 2 years.
  • Chronic systemic immunosuppressive medications (>14 days) within 6 months of study day 0 (e.g., cytotoxic medications, adrenocorticotrophic hormone, or oral/parental corticosteroids equivalent to >0.5 mg/kg/day of prednisone). Corticosteroid nasal spray for allergic rhinitis and topical corticosteroids for mild, uncomplicated dermatitis are allowed at the discretion of the investigator.
  • Investigational or non-FDA approved/authorized product or vaccine within 28 days prior to study day 0.
  • Asplenia or functional asplenia.
  • Blood transfusion or IVIG within 6 months of study day 0.
  • Any other finding that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a subject s ability to give informed consent, or increase the risk of having an adverse outcome from participating in the study.
  • Subjects who are excluded from participation for any of the reasons above may be considered for
  • enrollment on a postponed schedule if the investigator considers this appropriate.
  • Subjects will be selected in an equitable manner from the available pool of potentially eligible individuals, without regard to factors such as sex, gender, race, ethnicity, socioeconomic status, etc., except for age.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: 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

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.

Read more

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.

...

Read the 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
Conditions
Malaria
Being tested
Pvs230D1-EPA/Matrix-M
Keywords
TBV, Open Label, Antibody, Reactogencity, Mosquito
Medical subject headings
Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pvs230D1-EPA/Matrix-MDrug

    Pvs230 domain 1 (Pvs230D1) is a recombinant protein consisting of subdomain 1 of native Pvs230 (Val-226 to Gly-427, Figure 2) produced in Pichia pastoris. The synthetic gene sequence was optimized for P. pastoris expression and cloned into the expression vector pPICZ(alpha)A, which also encodes a pre-prosecretory alpha-factor sequence.

Study groups in NCT05913973
Study groupRoleWhat they receive
Group 1Experimental5 (micro)g Pvs230D1-EPA/50 (micro)g MM
Receives: Drug: Pvs230D1-EPA/Matrix-M
Group 2Experimental25 (micro)g Pvs230D1-EPA/50 (micro)g MM
Receives: Drug: Pvs230D1-EPA/Matrix-M
Group 3Experimental50 (micro)g Pvs230D1-EPA/50 (micro)g MM
Receives: Drug: Pvs230D1-EPA/Matrix-M

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Incidence and severity of local and systemic adverse events (AEs) or serious adverse events (SAEs)

    Measured: Receipt of first vaccine through subject study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start4 Aug 2023
  3. Primary completion12 Nov 2025
  4. Study completion12 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05913973
Sponsor's protocol ID
10001501
Other IDs
001501-I
Status last verified
26 Nov 2025
First submitted
19 Jun 2023
Last updated
1 Dec 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: This study will be conducted in accordance with the following publication and data sharing policies and regulations:@@@@@@NIH Public Access Policy, which ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication.@@@@@@This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals. @@@@@@

Publications

  • Cao Y, da Silva Araujo M, Lorang CG, Dos Santos NAC, Tripathi A, Vinetz J, Kumar N. Distinct immunogenicity outcomes of DNA vaccines encoding malaria transmission-blocking vaccine target antigens Pfs230D1M and Pvs230D1. Vaccine. 2025 Feb 15;47:126696. doi: 10.1016/j.vaccine.2024.126696. Epub 2025 Jan 8.

    PubMed 39787798

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pvs230D1-EPA/Matrix-M in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the safety and reactogenicity of Pvs230D1-EPA/MM in healthy malaria-naive adults (time frame: Receipt of first vaccine through subject study completion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05913973, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.

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