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

• 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: Fraunhofer, Center for Molecular Biotechnology
• Information provided by (Responsible Party): Fraunhofer, Center for Molecular Biotechnology

Tracking Information

• First Submitted Date: November 25, 2013
• First Posted Date: December 17, 2013
• Results First Submitted Date: November 21, 2016
• Results First Posted Date: January 18, 2017
• Last Update Posted Date: March 8, 2017
• Study Start Date: October 2013
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: December 11, 2013): Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 420 days ]

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Malaria
• Intervention: Biological: Pfs25 VLP- FhCMB

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 11, 2013): 44
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 2015
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02013687
• Other Study ID Numbers: FhCMB Pfs25-001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Fraunhofer, Center for Molecular Biotechnology
• Original Responsible Party: Same as current
• Current Study Sponsor: Fraunhofer, Center for Molecular Biotechnology
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Fraunhofer, Center for Molecular Biotechnology
• Verification Date: January 2017