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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Malaria Biological: Pfs25 VLP- FhCMB Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 1 Study of the Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
Study Start Date : October 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arms and Interventions
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Arm Intervention/treatment
Experimental: 2 µg + Alhydrogel
vaccine
 Biological: Pfs25 VLP- FhCMB
Experimental: 10 µg + Alhydrogel
vaccine
 Biological: Pfs25 VLP- FhCMB
Experimental: 30 µg + Alhydrogel
vaccine
 Biological: Pfs25 VLP- FhCMB
Experimental: 100 µg + Alhydrogel
vaccine
 Biological: Pfs25 VLP- FhCMB


Outcome Measures
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Primary Outcome Measures :
  1. Subjects With at Least One Adverse Event [ Time Frame: 336 days ]
  2. Subjects With Solicited Systemic Adverse Events [ Time Frame: 336 days ]
  3. Subjects With Solicited Local Adverse Events [ Time Frame: 336 days ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013687


Locations
United States, Maryland
Accelovance
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
Fraunhofer, Center for Molecular Biotechnology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Fraunhofer, Center for Molecular Biotechnology
ClinicalTrials.gov Identifier: NCT02013687     History of Changes
Other Study ID Numbers: FhCMB Pfs25-001
First Posted: December 17, 2013    Key Record Dates
Results First Posted: January 18, 2017
Last Update Posted: March 8, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
 Vaccines
Immunologic Factors
Physiological Effects of Drugs