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

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ClinicalTrials.gov Identifier: NCT02655549
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Pfenex, Inc

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

Condition or disease Intervention/treatment Phase
Anthrax Biological: Px563L, RPA563, or placebo Phase 1

Detailed Description:
This is a Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of Px563L or RPA563 administered intramuscularly. All subjects will be followed for safety and tolerability for 393 days after the initial vaccination. Immunogenicity analyses will be performed for up to 182 days, including an interim analysis based on Day 70 results, after the initial vaccination.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1a Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study Assessing Safety and Immunogenicity of Px563L and RPA563 Administered by Intramuscular Injection in Healthy Adult Volunteers
Actual Study Start Date : December 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anthrax

Arm Intervention/treatment
Experimental: Cohort 1 of Px563L, RPA563, or placebo
Intramuscular injections of Px563L, RPA563, or placebo
Biological: Px563L, RPA563, or placebo
Two intramuscular injections

Experimental: Cohort 2 of Px563L, RPA563, or placebo
Intramuscular injections of Px563L, RPA563, or placebo
Biological: Px563L, RPA563, or placebo
Two intramuscular injections

Experimental: Cohort 3 of Px563L, RPA563, or placebo
Intramuscular injections of Px563L, RPA563, or placebo
Biological: Px563L, RPA563, or placebo
Two intramuscular injections




Primary Outcome Measures :
  1. Adverse events (AE) and adverse events of special interest (AESI) for vaccines [ Time Frame: 393 days ]

Secondary Outcome Measures :
  1. Anthrax toxin neutralizing antibody (TNA) 50% neutralization factor (NF50) value [ Time Frame: 182 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT02655549


Locations
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United States, Kansas
Quintiles Phase One Services
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Pfenex, Inc
Department of Health and Human Services
Investigators
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Principal Investigator: Barbara K Lomeli, M.D. Quintiles Phase One Services, LLC
Study Director: Hubert C Chen, M.D. Pfenex, Inc

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Responsible Party: Pfenex, Inc
ClinicalTrials.gov Identifier: NCT02655549     History of Changes
Other Study ID Numbers: PF563-101
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Anthrax
Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections