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 | Completed Phase 1 FDA Drug

• 2 other identifiers: 10001501001501-I
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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. ...

Conditions

Malaria

Keywords

TBV; Open Label; Antibody; Reactogencity; Mosquito

Outcome Measures

Primary Outcomes (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)

  Receipt of first vaccine through subject study completion

Study Arms (3)

Group 1

EXPERIMENTAL

5 (micro)g Pvs230D1-EPA/50 (micro)g MM

Drug: Pvs230D1-EPA/Matrix-M

Group 2

EXPERIMENTAL

25 (micro)g Pvs230D1-EPA/50 (micro)g MM

Drug: Pvs230D1-EPA/Matrix-M

Group 3

EXPERIMENTAL

50 (micro)g Pvs230D1-EPA/50 (micro)g MM

Drug: Pvs230D1-EPA/Matrix-M

Interventions

Pvs230D1-EPA/Matrix-M DRUG

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.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• 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.

  PMID: 39787798 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Joel A Goldberg, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 22, 2023
• Study Start: August 4, 2023
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11-26

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)