Pvs230D1-EPA/Matrix-M Vaccine for Malaria
What You Need to Know Before You Apply
What is the purpose of this trial?
Background:
Malaria is a disease caused by parasites spread by mosquito bites. Researchers want to test a vaccine that could stop mosquitoes from picking up these parasites when they bite infected people. This could stop malaria from spreading.
Objective:
To test a study vaccine (Pvs230D1-EPA/MM) to stop malaria transmission in healthy adults.
Eligibility:
Healthy people aged 18 to 54 years. People who already received the vaccine during a different study are also needed.
Design:
Participants will be screened. They will have a physical exam. They will have blood tests and a test of their heart function (a simple electrocardiogram or EKG).
The vaccine is given as an injectionin the upper arm. Participants who have never gotten the study vaccine will get 3 vaccines; each injection will be about 1 month apart. Participants who were vaccinated before will receive only 1 vaccine for this study. All participants will have multiple phone and in-person follow-up visits after each vaccination.
Two to 12 weeks after their last vaccine, all participants will be injected with live malaria parasites. Then they will be seenin the clinic for about 3 days. They will be monitored daily until they develop symptoms of malaria, usually in about 10 days then will be admitted to the NIH hospital.
While in the NIH hospital, participants will have 3 mosquito feedings: Two cups containing mosquitoes will be placed on an arm or leg. The mosquitoes will feed for about 15 minutes. Participants will receive medicines to relieve discomfort from the bites.
Participants will then be treated for malaria. They will have follow-up visits and calls until they fully recover.
Who Is on the Research Team?
Shanan R Immel, M.D.
Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18 to 54 who have never had malaria. Both people new to the study vaccine and those who received it in a previous study can join.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Pvs230D1-EPA/Matrix-M
Trial Overview
Researchers are testing a new malaria vaccine (Pvs230D1-EPA/Matrix-M) given as up to three shots, followed by exposure to live malaria parasites and mosquito bites, to see if the vaccine can stop transmission of malaria.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Three doses of 5microg Pvs230D1-EPA/50microg MM will be administered at 1-month intervals, via intramuscular (IM) injection. Two to twelve weeks after the final vaccination, challenge agent derived from a cell bank of cryopreserved blood-stage P. vivax (PvHMB-CCE001) will be administered intravenously (IV). Participants will be monitored and admitted to the NIHCC to undergo safety monitoring, transmission assays, and receive antimalarial treatment.
A fourth (booster) dose of of Pvs230D1-EPA/MM will be given to participants who previously received the primary vaccine series while enrolled in NIH protocol 001501, at a dose identical to that which the participant received under NIH Protocol 1501 (i.e., 5microg Pvs230D1-EPA/50microg MM, 25microg Pvs230D1-EPA/50microg MM, or 50microg Pvs230D1-EPA/50microg MM).Optionally, two to twelve weeks after the final vaccination, challenge agent derived from a cell bank of cryopreserved blood-stage P. vivax (PvHMB-CCE001) will be administered intravenously (IV). Participants will be monitored and admitted to the NIHCC to undergo safety monitoring, transmission assays, and receive antimalarial treatment.
Participants enrolled on NIH protocol 001970, Induced blood-stage malaria in healthy malaria-naive adults to assess the safety and infectivity of Plasmodium vivax challenge agent and evaluate transmission in mosquito feeding assays , will serve as open-label controls.
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Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
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