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Study of the Transmission-Blocking Vaccine Pfs230D1-EPA/Matrix-M Against Malaria in Adults in Mali

NCT05135273 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-05-06

Study results available
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Summary

Background:

Researchers are trying to develop a vaccine that will safely reduce the spread of malaria in the community by preventing mosquitos from carrying malaria from person to person.

Objective:

To assess in African adults the safety of and immune response to the administration of Pfs230D1-EPA/Matrix-M vaccine as compared to the rabies vaccine control.

Eligibility:

Healthy adults (18 to 50 years of age) who reside in Sotuba and surrounding villages in Mali

Design:

Participants will be screened with:

* Medical history
* Physical exam
* Blood, urine, and heart tests
* Malaria comprehension exam

Participants will be randomly assigned to get either the experimental vaccine or the approved rabies vaccine. They will not know which they are getting.

Participants will get 3 doses of the study or comparator vaccine via injection in the upper arm. This occurs at the first visit, 1 month, and 2 months later.

Participants will have up to 23 scheduled visits over 14 to 16 months. Each visit includes a physical exam, and blood will be collected at most visits.

Participants will be followed up to 1 year after the final vaccination.

If participants develop an injection site rash or reaction, photographs may be taken of the site.

Conditions

  • Malaria,Falciparum

Interventions

BIOLOGICAL

Pfs230D1-EPA/Matrix-M Vaccine

Each single-use vial of Pfs230D1M-EPA contains 160 µg/mL of conjugated Pfs230D1M and 124 µg/mL or 143 µg/mL of conjugated EPA in 4 mM phosphate-buffered saline (PBS), in a volume of 0.5 mL. Each vial of Matrix-M1 contains saponin content of 0.375 mg/mL in PBS, at a pH of 7.2, in a final volume of 0.75 mL. Components will be combined in volumes defined in the protocol at point of use.

BIOLOGICAL

Verorab Rabies Vaccine

Verorab Rabies Vaccine is a purified inactivated rabies vaccine (Wistar rabies PM/WI 38 1503-3M strain) prepared on Vero cells. It is supplied as a powder and solvent for suspension for injection in a prefilled syringe. Before reconstitution, the powder is a white and homogeneous pellet. The solvent is a limpid solution.

Sponsors & Collaborators

  • Novavax

    collaborator INDUSTRY

  • Malaria Research and Training Center, Bamako, Mali

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Patrick Duffy, MD · National Institute of Allergy and Infectious Diseases (NIAID)

  • Issaka Sagara, MD · Malaria Research and Training Center, Bamako, Mali

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-22
Primary Completion
2023-02-17
Completion
2023-06-21
FDA Drug
Yes

Countries

  • Mali

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05135273 on ClinicalTrials.gov