A Study of Anthrax Vaccines Px563L and RPA563 in Healthy Adult Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Anthrax

In brief

The trial investigates Px563L and RPA563, two formulations of a novel anthrax vaccine.

Key facts

Study ID

NCT02655549

Run by

Pfenex, Inc

People needed

54

Starts

2015-12-01

Expected to finish

2017-06-01

Last updated by the study team

2017-07-11

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Willing and able to read and understand the consent process and sign an informed consent form (ICF).
• Females or males between the ages of 18 and 55, inclusive, at the time of informed consent.
• Healthy or with stable medical conditions not requiring continuous medication.

You may not qualify if…

• Female subjects who are pregnant or breastfeeding.
• A history of anthrax disease or receipt of an anthrax vaccine at any time in the past, exposure to or infection with B. anthracis, or has received any investigational anthrax vaccine or treatment (e.g., monoclonal antibodies, anthrax immune globulin).
• Positive test for human immunodeficiency virus (HIV), hepatitis C or hepatitis B (surface antigen).
• History of any malignant neoplasm or receipt of anti-neoplastic agents within the last 5 years, with the exception of adequately treated, localized or in situ non-melanoma of the skin (e.g., basal cell carcinoma) or of the cervix.
• History of immunodeficiency, chronic illness requiring continuous or frequent medical intervention, autoimmune disease, bleeding disorder, hemoglobinopathy, prior solid organ or bone marrow transplant, or any known history in the past 5 years of cardiac disease.
• Evidence of alcohol abuse (i.e., requiring treatment) or substance abuse (i.e., any use of illicit drugs) within 6 months prior to screening.
• History of severe allergy (e.g., anaphylaxis) to latex or rubber.
• Subjects who have significant scarring, tattoos, abrasions, rash, or other skin abnormality at the planned vaccination site that could interfere with evaluation of injection site..
• Use of any systemic steroids or other immunosuppressive agents within 2 years prior to screening; or use of topical, intranasal, or inhaled corticosteroids for ≥10 consecutive days within 1 year prior to screening.
• Administration of any licensed vaccines within 30 days prior to screening.
• History of anaphylaxis or other serious adverse reaction to vaccines.
• Donation or loss of >500 mL of blood or donation of plasma within 2 months of screening, or recipient of blood or blood products within 2 months of screening.
• Present or former member of US military or reservist who may have or will receive the licensed anthrax vaccine, or who has served in any military arena from January 1990 through present time.
• May be at risk for exposure to anthrax or may be required to receive the licensed anthrax vaccine (e.g., postal workers).
• Has previously participated in any anthrax vaccine or anti-protective antigen (PA) monoclonal antibody clinical trial.

Where it is running

• Quintiles Phase One Services — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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