Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults

Inclusion Criteria:

- 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:

1. At least one year post-menopausal

2. Surgically sterile

3. Willing to use oral, implantable, transdermal or injectable contraceptives for
30 days prior to first vaccination and then for the study duration

4. 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.

Exclusion Criteria:

- History of malaria or previous receipt of an investigational malaria vaccine