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

Completed · Phase 1

Conditions studied: Malaria

In brief

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

Key facts

Study ID

NCT02013687

Run by

Fraunhofer, Center for Molecular Biotechnology

People needed

44

Starts

2013-10-01

Expected to finish

2015-01-01

Last updated by the study team

2017-03-08

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Accelovance — Rockville, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.