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PA83-FhCMB Plant-Derived Recombinant Protective Antigen (rPA) Anthrax Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02239172
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Fraunhofer, Center for Molecular Biotechnology

Tracking Information
First Submitted Date  ICMJE August 13, 2014
First Posted Date  ICMJE September 12, 2014
Last Update Posted Date May 12, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2014)
Number of Participants with Adverse Events [ Time Frame: Up to 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02239172 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2014)
Change from Baseline in antibody titer after three immunizations [ Time Frame: Up to 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PA83-FhCMB Plant-Derived Recombinant Protective Antigen (rPA) Anthrax Vaccine
Official Title  ICMJE A Phase 1 Study of the Safety and Immunogenicity of Plant-Derived Recombinant Protective Antigen (rPA) Anthrax Vaccine in Healthy Adults
Brief Summary The purposes of this study is to evaluate and compare the safety, reactogenicity, and tolerability of the PA83-FhCMB vaccine candidate delivered at 4 dose levels with Alhydrogel
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Anthrax
Intervention  ICMJE Biological: PA83-FhCMB
Study Arms  ICMJE
  • Experimental: 12.5 µg + Alhydrogel
    vaccine
    Intervention: Biological: PA83-FhCMB
  • Experimental: 25 µg + Alhydrogel
    vaccine
    Intervention: Biological: PA83-FhCMB
  • Experimental: 50 µg + Alhydrogel
    vaccine
    Intervention: Biological: PA83-FhCMB
  • Experimental: 100 µg + Alhydrogel
    vaccine
    Intervention: Biological: PA83-FhCMB
Publications * Not Provided

*   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: September 10, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Citizen or permanent resident of the US
  • Male or female aged 18 to 49 years inclusive
  • Able to give written informed consent
  • Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations at baseline
  • Females should fulfill one of the following criteria:

    1. At least one year post-menopausal
    2. Surgically sterile
    3. Willing to use a medically approved form of contraception (eg, oral, implantable, transdermal, or injectable hormonal contraceptive; intrauterine device; barrier protection to include female condom, diaphragm, cervical cap, or male condoms in conjunction with spermicide) for 30 days prior to first vaccination and through the end of the study
    4. Willing to abstain from sexual intercourse for 30 days prior to first vaccination and through the end of the study
  • Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of each dose
  • Comprehension of the study requirements
  • Expressed availability for the required study period
  • Ability to attend scheduled visits and to be contacted by telephone throughout the follow-up period

Exclusion Criteria:

  • History of anthrax disease or receipt of anthrax vaccine
  • Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical or surgical treatment or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening
  • Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies
  • Pregnancy or lactation
  • Cancer or treatment for cancer, within the previous 3 years, excluding basal cell carcinoma
  • Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus, per the investigator's discretion
  • Presently receiving or history of receiving, during the preceding 3-month period, any medications or other treatments that may adversely affect the immune system

    1. This includes allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs, or systemic corticosteroids (oral or injectable; 20 mg/day x 14 days or longer)
    2. Radiation therapy
    3. Intranasal and topical corticosteroids will be allowed
  • Receipt or planned administration of a non study vaccine within 14 days prior to vaccination and throughout the study period (30 days for live vaccines) Immunization on an emergency basis with Tetanus Toxoids Adsorbed for adult use (Td or Tdap) or influenza vaccine up to 14 days before or at least 14 days after a dose of study vaccine will be allowed
  • History of anaphylactic type reaction to injected vaccines
  • History of drug or chemical abuse in the year before the study
  • Receipt of any investigational product or nonregistered drug within 30 days prior to vaccination or currently enrolled in any investigational drug study or intends to enroll in such a study within the ensuing study period
  • Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the study period
  • Donation of blood or blood products within 8 weeks prior to vaccination or at any time during the study
  • Acute disease within 72 hours prior to vaccination

    1. Acute disease is defined as the presence of a moderate or severe illness (as determined by the Investigator through medical history and physical examination) with or without fever (≥38°C; 100.4°F), or an oral temperature of ≥38°C orally
    2. Study vaccine can be administered to persons with a minor illness
  • History of immunodeficiency, chronic illness requiring continuous or frequent medical intervention, autoimmune disease, use of immunosuppressive medications, or ongoing therapy with systemic corticosteroids within 3 months prior to any planned vaccine dose. Inhaled and topical steroids are permitted. "Burst" therapy of steroids is permitted except within 2 weeks prior to vaccination.
  • Evidence of psychiatric, medical and/or substance abuse problems during the past 6 months that the investigator believes would adversely affect the subject's ability to participate in the trial
  • Occupational or other responsibilities that would prevent completion of participation in the trial, including:

    1. US military or reservists who may receive the licensed anthrax vaccine (BioThrax) or served during the Persian Gulf War between January and May, 1991. Such individuals may be enrolled only if they provide their medical records, which can then show proof that they have not received the licensed anthrax vaccine.
    2. Postal and other workers who may be exposed to anthrax or may have to take BioThrax
  • Any condition that, in the opinion of the investigator, might interfere with interpretation of data supporting the primary study objectives
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 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 NCT02239172
Other Study ID Numbers  ICMJE FhCMB rPA83-001
Has Data Monitoring Committee No
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 May 2016

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