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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

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

Condition or disease Intervention/treatment Phase
Anthrax Biological: PA83-FhCMB Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Phase 1 Study of the Safety and Immunogenicity of Plant-Derived Recombinant Protective Antigen (rPA) Anthrax Vaccine in Healthy Adults
Study Start Date : August 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anthrax

Arm Intervention/treatment
Experimental: 12.5 µg + Alhydrogel
vaccine
Biological: PA83-FhCMB
Experimental: 25 µg + Alhydrogel
vaccine
Biological: PA83-FhCMB
Experimental: 50 µg + Alhydrogel
vaccine
Biological: PA83-FhCMB
Experimental: 100 µg + Alhydrogel
vaccine
Biological: PA83-FhCMB



Primary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: Up to 3 months ]

Secondary Outcome Measures :
  1. Change from Baseline in antibody titer after three immunizations [ Time Frame: Up to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02239172


Locations
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United States, Maryland
Walter Reed Army Institute of Research, Clinical Trials Center
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
Fraunhofer, Center for Molecular Biotechnology

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Responsible Party: Fraunhofer, Center for Molecular Biotechnology
ClinicalTrials.gov Identifier: NCT02239172     History of Changes
Other Study ID Numbers: FhCMB rPA83-001
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Anthrax
Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs