National Institute of Allergy and Infectious Diseases (NIAID)
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.
Study Description: This is a single-site, phase 1/2 study of Pvs230D1-EPA/MM and bloodstage controlled human malaria infection and transmission (CHMI-T) model in healthy malaria-naive adults at the NIH Clinical Center (NIHCC), to assess the safety, reactogenicity, and efficacy of Pvs230D1-EPA/Matrix- M (MM). Three doses of the primary vaccine series will be administered at 1-month intervals (study days 0, 28, and 56) to those who are vaccine naive. Concurrently, a fourth (booster) dose will be given to participants who previously received the primary vaccine series while enrolled in NIH proto…
* INCLUSION CRITERIA: All Participants In order to participate in this study, an individual must meet all of the following criteria: * Age \>=18 and \<=54 years at the time of enrollment in this protocol, or for booster participants, at the time of enrollment into NIH protocol 001501. * In good general health and without clinically significant medical history. * Able to provide informed consent. * Study comprehension exam passed (a score of \>=80% or per investigator's discretion) prior to study activities. * Individuals of childbearing potential must agree to use an acceptable method of co…
Challenge agent derived from cryopreserved cell bank PvHMB-CCE001 which contains the P. vivax isolate HMP013 in red blood cells derived from a healthy US adult donor.
A protein subunit conjugate vaccine Pvs230D1-EPA formulated with adjuvant Matrix-M