NCT02013687CompletedPhase 1
A Phase 1 Study of the Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
Fraunhofer, Center for Molecular Biotechnology2 sites in 1 country44 target enrollmentStarted: October 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Subjects With Solicited Systemic Adverse Events
Study Overview
Brief Summary
This study is a Phase 1, dose escalation, first-in-human study designed primarily to evaluate the safety of the purified plant-derived Pfs25 VLP combined with Alhydrogel adjuvant
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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:
- •At least one year post-menopausal
- •Surgically sterile
- •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.
Exclusion Criteria
- •History of malaria or previous receipt of an investigational malaria vaccine
Outcomes
Primary Outcomes
Subjects With Solicited Systemic Adverse Events
Time Frame: 336 days
Subjects With Solicited Local Adverse Events
Time Frame: 336 days
Subjects With at Least One Adverse Event
Time Frame: 336 days
Secondary Outcomes
- Assessment of Anti-Pfs25 IgG Following the Third Immunization.(196 days)
- Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite(196 days)
Investigators
Study Sites (2)
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