Pvs230D1-EPA/Matrix-M Vaccine for Malaria
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on chronic systemic immunosuppressive medications, you may need to stop them at least 6 months before starting the study.
What data supports the effectiveness of the Pvs230D1-EPA/Matrix-M treatment for malaria?
The research highlights the development of malaria vaccines using protein-based approaches, similar to the Pvs230D1-EPA/Matrix-M treatment, which involves protein antigens and adjuvants (substances that enhance the body's immune response to an antigen). These approaches have shown promise in inducing immune responses against various stages of the malaria parasite's lifecycle, suggesting potential effectiveness for the Pvs230D1-EPA/Matrix-M treatment.12345
How is the Pvs230D1-EPA/Matrix-M treatment for malaria different from other treatments?
The Pvs230D1-EPA/Matrix-M treatment is unique because it targets the sexual stage of the malaria parasite in mosquitoes, aiming to block transmission rather than just treating the infection in humans. This approach uses a protein-based vaccine with an adjuvant to enhance immune response, which is different from traditional malaria treatments that focus on killing the parasite in the human host.26789
What is the purpose of this trial?
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.
Research Team
Joel A Goldberg, M.D.
Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria
Healthy adults aged 18-50 who can consent to the study, understand it well, and have reliable access to NIHCC for visits. They must agree to use contraception and not donate blood during the trial. Excluded are pregnant or breastfeeding individuals, those with certain medical conditions or treatments that affect immune function, and anyone planning travel to malaria-endemic areas.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive three doses of the vaccine at 1-month intervals
Monitoring
Participants have 12 additional clinic visits for monitoring, including physical exams and blood tests
Follow-up
Participants are monitored for safety and effectiveness after treatment with follow-up phone calls
Treatment Details
Interventions
- Pvs230D1-EPA/Matrix-M
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor