Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
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Subjects With at Least One Adverse Event [ Time Frame: 336 days ]
Subjects With Solicited Systemic Adverse Events [ Time Frame: 336 days ]
Subjects With Solicited Local Adverse Events [ Time Frame: 336 days ]
Secondary Outcome Measures :
Assessment of Anti-Pfs25 IgG Following the Third Immunization. [ Time Frame: 196 days ]
Serum anti-Pfs25 antibody IgG titers determined using an ELISA unit assay.
Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite [ Time Frame: 84 days ]
Assessment of TRA, as measured by the standard membrane feeding assay (SMFA), one month after the second vaccination (Study Day 84) in either the 30 μg or 100 μg dose groups.
Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite [ Time Frame: 196 days ]
Assessment of TRA, as measured by the standard membrane feeding assay (SMFA), showing ≥80% reduction of oocysts in Anopheles mosquito gut in ≥50% of the subjects with Study Day 196 sera (one month after the third vaccination) (Study Day 196) in either the 30 μg or 100 μg dose groups.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 50 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or non-pregnant, non-lactating female aged 18 - 50 years inclusive
Able to give written informed consent obtained prior to screening
Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations at baseline
Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of each dose.
Females should fulfill one of the following criteria:
At least one year post-menopausal
Willing to use oral, implantable, transdermal or injectable contraceptives for 30 days prior to first vaccination and then for the study duration
Willing to abstain from sexual intercourse or use another reliable form of contraception approved by the Investigator (e.g., intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, use of condom by the sexual partner or a sterile sexual partner) for 30 days prior to first vaccination through 9 months after third vaccination
Comprehension of the study requirements, as demonstrated by achieving a score of at least 80% correct on a short multiple-choice quiz.
Individuals who fail to achieve a passing score on the initial comprehension assessment will be given the opportunity to retest after a review of protocol information.
Individuals who fail the comprehension assessment for the second time will not be enrolled.
Available and able to participate in all planned study visits and procedures.
History of malaria or previous receipt of an investigational malaria vaccine