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

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ClinicalTrials.gov Identifier: NCT02013687
Recruitment Status : Completed
First Posted : December 17, 2013
Results First Posted : January 18, 2017
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Fraunhofer, Center for Molecular Biotechnology

Tracking Information
First Submitted Date  ICMJE November 25, 2013
First Posted Date  ICMJE December 17, 2013
Results First Submitted Date  ICMJE November 21, 2016
Results First Posted Date  ICMJE January 18, 2017
Last Update Posted Date March 8, 2017
Study Start Date  ICMJE October 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 11, 2013)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 420 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
Official Title  ICMJE A Phase 1 Study of the Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Malaria
Intervention  ICMJE Biological: Pfs25 VLP- FhCMB
Study Arms  ICMJE
  • Experimental: 2 µg + Alhydrogel
    vaccine
    Intervention: Biological: Pfs25 VLP- FhCMB
  • Experimental: 10 µg + Alhydrogel
    vaccine
    Intervention: Biological: Pfs25 VLP- FhCMB
  • Experimental: 30 µg + Alhydrogel
    vaccine
    Intervention: Biological: Pfs25 VLP- FhCMB
  • Experimental: 100 µg + Alhydrogel
    vaccine
    Intervention: Biological: Pfs25 VLP- FhCMB
Publications * Chichester JA, Green BJ, Jones RM, Shoji Y, Miura K, Long CA, Lee CK, Ockenhouse CF, Morin MJ, Streatfield SJ, Yusibov V. Safety and immunogenicity of a plant-produced Pfs25 virus-like particle as a transmission blocking vaccine against malaria: A Phase 1 dose-escalation study in healthy adults. Vaccine. 2018 Sep 18;36(39):5865-5871. doi: 10.1016/j.vaccine.2018.08.033. Epub 2018 Aug 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2013)
44
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02013687
Other Study ID Numbers  ICMJE FhCMB Pfs25-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Fraunhofer, Center for Molecular Biotechnology
Study Sponsor  ICMJE Fraunhofer, Center for Molecular Biotechnology
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fraunhofer, Center for Molecular Biotechnology
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP