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History of Changes for Study: NCT02013687
Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
Latest version (submitted January 25, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 11, 2013 None (earliest Version on record)
2 August 5, 2014 Recruitment Status, Study Status and Contacts/Locations
3 March 4, 2015 Study Status
4 June 16, 2015 Study Status
5 May 10, 2016 Recruitment Status, Study Status, Arms and Interventions, Study Design and IPDSharing
6 November 21, 2016 Study Status, Outcome Measures and Results
7 January 25, 2017 Study Status, Outcome Measures, Baseline Characteristics and Study Design
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Study NCT02013687
Submitted Date:  December 11, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: FhCMB Pfs25-001
Brief Title: Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
Official Title: A Phase 1 Study of the Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2013
Overall Status: Recruiting
Study Start: November 2013
Primary Completion: March 2015 [Anticipated]
Study Completion: July 2015 [Anticipated]
First Submitted: November 25, 2013
First Submitted that
Met QC Criteria:
December 11, 2013
First Posted: December 17, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 11, 2013
Last Update Posted: December 17, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Fraunhofer, Center for Molecular Biotechnology
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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
Detailed Description:
Open or close this module Conditions
Conditions: Malaria
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: N/A
Enrollment: 44 [Anticipated]
Open or close this module Arms and Interventions
Intervention Details:
Biological: Pfs25 VLP- FhCMB
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability
[ Time Frame: 420 days ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 50 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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
Open or close this module Contacts/Locations
Locations: United States, Maryland
Accelovance
[Recruiting]
Rockville, Maryland, United States, 20850
Contact:Contact: Stephan Bart, MD 240-238-4953
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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